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A Timeline of Ivermectin-Related Events in the COVID-19 Pandemic [March 24, 2021]

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Abstract

This is an outdated version of the first part of the timeline. Please see current versions *** Part 0: https://www.researchgate.net/publication/348077948 *** Part 1: https://doi.org/10.13140/RG.2.2.13705.36966 *** Part 2: https://doi.org/10.13140/RG.2.2.16973.36326 *** Part 3: https://doi.org/10.13140/RG.2.2.23081.72805 *** Part 4: https://doi.org/10.13140/RG.2.2.26000.53767 *** Part 5: https://doi.org/10.13140/RG.2.2.35015.16807 *** Additional notes (Feb-Apr 2022): https://doi.org/10.13140/RG.2.2.24356.55682 ***
A timeline of ivermectin-related events in the COVID-19
pandemic
Mika Turkia
M.Sc., mika.turkia@alumni.helsinki.fi, March 24, 2021
Abstract
Ivermectin is an antiparasitic medication invented in Japan in 1975 by Kitasato University professor emeritus
Satoshi ¯
Omura, for which he won the 2015 Nobel Prize in physiology or medicine. The drug proved effective
in eradicating parasitic infections, with several billion doses administered since 1981. The patent for the
product was owned by Merck & Co/MSD. In most countries the patent expired in 1996. Currently, ivermectin
preparations are available internationally from many sources, with the production cost of a single dose
estimated to be less than 0.1 US dollars.
The interest in ivermectin with regard to COVID-19 was initiated by an Australian in vitro study published
on April 3, 2020, indicating that a a single treatment with ivermectin effected an approximately 5000-fold
reduction in SARS-CoV-2 virus at 48 h in cell culture. A few days later, two doctors in Peru begun treating
a COVID-19 outbreak in a prison with ivermectin, later also treating the local police.
In the second and third quarter of 2020 the use of ivermectin spread to or emerged independently in other
South and Central American countries, Egypt and India. The first country to adopt it nationwide appears
to have been Honduras, followed by Peru and Bangladesh. Eventually in the fourth quarter of 2020 and
the first quarter of 2021 it spread to Lebanon and selected countries of Southern Africa and Southeastern
Europe, with Slovakia being the first European Union country to adopt ivermectin for COVID-19, followed
by Bulgaria and the Czech Republic.
Ivermectin treatments raised controversy within most wealthy industrialized countries including other Euro-
pean Union countries and the United States ignoring ivermectin referring to lack of evidence of its efficacy
and safety. There was a difference in attitudes: many developing countries acted early based on clinical
experimentation or their own clinical trials initiated early in 2020, whereas the industrialized countries pre-
dominantly did not initiate ivermectin trials and appeared to rely solely on recommendations of the World
Health Organization (WHO), the US National Institutes of Health (NIH), the US Food and Drug Admin-
istration (FDA), and the European Medicine Agency (EMA), which held predominantly negative views on
ivermectin. Many developing countries adopted ivermectin before the existence of any trial results, whereas
the industrialized countries did not adopt it even after results of twenty randomized controlled clinical trials
were available in February 2021. The WHO initiated its first ivermectin trial in late February 2021.
In the United States, allocation of government funding between novel and existing pharmaceuticals appeared
inefficient at times, with significant government funding allocated for example to the development of a novel
pharmaceutical estimated to possess an efficacy comparable to ivermectin but priced several magnitudes
higher.
Major social media companies censored ivermectin researchers and research, with for example YouTube
censoring results of a meta-analysis commissioned by the WHO. Traditional media in the USA and the
European Union appeared to either ignore ivermectin or publish negative commentaries only.
This article aims at giving a brief overview of ivermectin-related events, presenting them on a timeline from
April 2020 to the second half of March 2021. There was a widespread disagreement on the fundamentals:
which methods were appropriate as a basis for decision making, what counted as evidence, and what was
ethical.
Keywords: COVID-19, SARS-CoV-2, ivermectin
ORCID iD: 0000-0002-8575-9838
1
Introduction
This article aims at giving an overview of the ivermectin controversy, including current practices of research,
publishing and governmental policy formation, by presenting a timeline of relevant events, compiled from
peer-reviewed academic journals indexed in PubMed, preprint servers such as medRxiv, chemRxiv, SSRN,
Research Square and ResearchGate, international clinical trials registers, international newspapers and med-
ical news service providers as well as websites. As there have been a lot of sparsely documented events
internationally, the search has not been systematic, the timeline is unavoidably incomplete, and there may
naturally be some personal bias with regard to what has been selected. Also, the main focus of the article
is on the last quarter of the 2020s and the first quarter of 2021. Despite these limitations the timeline may
serve as a template for more detailed inquiries.
Due to the large number of studies and limited space, each study is mentioned only briefly, without a
possibility to analyze methodologies or results in depth. Statistically significant endpoints are reported,
with nonsignificant endpoints mostly left out. For consistency, results are in most cases formatted as they
appear in a meta-analysis by the CovidAnalysis research group, possibly reformulated in comparison to the
original sources (e.g. odds ratios converted to relative risk or methodological errors corrected).1,2,3
Ivermectin is best known as an antiparasitic agent. For prophylaxis of onchocerciasis (river blindness) and
strongyloidiasis it is administered as a single oral yearly dose of 0.15-0.20 mg/kg.4,5 For lymphatic filariasis,
a once-yearly dose of 0.3-0.4 mg/kg or bi-yearly dose of 0.15–0.2 mg/kg is administered.4For classic scabies,
two doses of 0.2 mg/kg approximately one week apart are recommended, and for crusted scabies three
to seven doses of 0.2 mg/kg depending on the infection severity.6,7 With regard to malaria, repurposing
ivermectin as a complement to current malaria vector control tools is currently being investigated, with a
proposed dosing regime of 0.4 mg/kg repeated three times during the malaria season, and another proposed
dosing regime of 0.3 mg/kg on three consecutive days in combination with two other pharmaceuticals also
repeated three times during the season.8
With regard to its in vitro antiviral action, ivermectin has shown robust antiviral action towards a range of
RNA and DNA viruses, including HIV-1, dengue, Zika and West Nile Virus, Venezuelan equine encephalitis
virus, Chikungunya, pseudorabies virus, adenovirus, and SARS-CoV-2 (COVID-19).9For dengue virus, a
combined phase II/III patient randomized controlled trial (RCT) has been completed.10
Another recent line of research has been an investigation into ivermectin’s efficacy in cancer. A study
found out that ivermectin at a very low dose drastically reversed the resistance of the tumor cells to the
chemotherapeutic drugs both in vitro and in vivo.11 Ivermectin could thus be used in combination with
chemotherapeutic agents to treat drug-resistant cancers.
With regard to the mechanism of action of ivermectin as an antiparasitic medication, Chung et al. describe
that ivermectin interacts with vertebrate and invertebrate γ-aminobutyric acid (GABA) receptor and inver-
tebrate glutamate-gated chloride channels, increasing chloride ion influx with subsequent paralysis and death
in the target organism.12 Ivermectin is effective in killing nematodes and arthropods with a single dose of 0.1-
0.3 mg/kg but has has a very wide margin of safety in mammals because in mammals GABA-mediated nerves
occur only in the central nervous system and ivermectin does not readily cross the blood-brain barrier.12
With regard to safety of overdosing, in chickens and most dogs subcutaneous doses of approximately 5
mg/kg have been shown to cause mild symptoms and doses of approximately 15 mg/kg severe symptoms
up to coma and death. In two described cases on humans, a 16-month-old child ingesting 6.7 to 8.7 mg/kg
ivermectin resulted in frequent vomiting, somnolence, mild tachycardia, and hypotension, and a 61-year old
woman became comatose three hours after ingesting 15.4 mg/kg agricultural ivermectin, requiring supportive
intensive care but was discharged uneventfully on day 9.12
The FDA-approved dosing for treatment of parasitic diseases is 0.2 mg/kg. The doses used in COVID-19 re-
lated clinical trials described in this article varied between 0.2-0.6 mg/kg. With regard to safety of ivermectin
in general, a current World Health Organization (WHO) document on the treatment of onchocerciasis states
that “ivermectin is safe and can be used on a wide scale”.13 With regard to safety for children, a recent
systematic review and and an individual patient data meta-analysis of ivermectin use in children weighing
less than 15 kg concluded that existing limited data between January 1980 and October 2019 suggest that
oral ivermectin in children weighing less than 15 kilograms is safe.14 Overall a total of 1.4% (15/1,088) of
children experienced 18 adverse events all of which were mild and self-limiting. No serious adverse events
were reported.
2
With regard to safety of ivermectin during pregnancy, a document from 2004 published by the WHO titled
“Mass treatment with ivermectin: an underutilized public health strategy” describes safety during pregnancy,
noting that “a number of follow-up studies have found that inadvertent filariasis mass campaign use of
ivermectin during pregnancy has not been associated with adverse pregnancy outcomes or negative effects
on pregnant women or their offspring”, referring to a study by Gyapong et al. who concluded “there is no
evidence of a higher risk of congenital malformation or abortions in those who are inadvertently exposed”.15,16
April 2020
On April 3, a Monash University of Australia in vitro ivermectin study by Caly et al. reported that
ivermectin is an inhibitor of SARS-CoV-2 virus in vitro, that a single treatment effected approximately
5000-fold reduction in virus at 48 h in cell culture, and that ivermectin is FDA-approved for parasitic
infections and included on the WHO model list of essential medicines, thus being widely available.17,18,19
On April 6, a French biotechnology company MedinCell which had been studying ivermectin for malaria
announced an initiative to develop an injectable form of ivermectin for prophylaxis of COVID-19.20,21,22
On April 10, mentioning increased interest in ivermectin after the Australian in vitro study, US FDA issued a
warning against using veterinary ivermectin as treatment for COVID-19 in humans, citing safety concerns.23
It noted additional testing is needed to determine whether ivermectin might be safe or effective in COVID-19
in humans.
On April 13, two Florida, US pulmonologists Rajter and Cepelowicz-Rajter were said to be pioneering early
treatments with ivermectin, reporting a nearly 100% response rate with early administration, adding that
they were initiating clinical studies.24
On April 13, a preprint by Patel et al. described an observational registry-based study from 169 hospitals
claiming that a single dose of 0.15 mg/kg of ivermectin produced a significant mortality reduction (7.7% vs.
18.6%) in 1,970 patients requiring mechanical ventilation.25,26
On April 14, two medical doctors, Gustavo Elera Arévalo and Fernando Polanco Hinostroza in La Merced
(Chanchamayo) in Peru, begun treating a COVID-19 outbreak in a prison with ivermectin, later also treating
the local police.27
On April 19, a second preprint by Patel et al. described an observational propensity-matched case-controlled
study in 1,408 patients (of which 704 received ivermectin) which claimed to demonstrate an association of
ivermectin use with lower in-hospital mortality 1.4% vs 8.5%, concluding that ivermectin was associated
with a potential survival benefit in COVID-19 and should be investigated urgently in randomized controlled
trials.28,29 The data was said to originate from an international multi-institutional deidentified healthcare
outcomes database compiled by Surgisphere Corporation, Chicago, IL, using data from hospitals located
throughout the world. The registry was said to ensure compliance with the FDA’s guidance on real-world
evidence. Data was said to have been collected through “automated data transfers that capture 100% of the
data from each healthcare entity at regular, predetermined intervals, thus reducing the impact of selection
bias”.
On April 19, Chaccour criticized the methods and the analysis of the Patel et al. study on Twitter, subse-
quently contacting the authors about inconsistencies in the data.30
On April 21, Antiviral Research journal published letters to the editors commenting the Caly et al. study,
with Rayner et al. commenting that “a small window exists for the current data to have relevance for humans”,
and Noël commenting that the higher than usual doses that would be necessary could be toxic and thus
a phase I study is absolutely needed. Jans and Wagstaff commented that a vitally important reason to be
very cautious is that ivermectin’s key direct target in mammalian cells is a not a viral component but a
host protein important in intracellular transport. They also commented that the basis of ivermectin’s broad-
spectrum activity against a number of different RNA viruses in vitro is the fact that it is a host-directed
agent (HDA), and the way a HDA can reduce viral load is by inhibiting a key cellular process that the
virus hijacks to enhance infection by suppressing the host antiviral response. Reducing viral load by even a
modest amount by using a HDA at low dose early in infection can be the key to enabling the body’s immune
system to begin to mount the full antiviral response before the infection takes control. However, it cannot
be assumed that even low doses are safe in the context of a burgeoning viral infection, where a measured
immune response is key to recovery.31
3
On April 23, Honduras adopted ivermectin country-wide.3
On April 26, a preprint by Schmith et al. described pharmacokinetic model simulations to predict plasma
concentration-time profiles after a single and repeat fasted administration of the approved dose of ivermectin
(200 μg/kg), noting that plasma or lung ivermectin concentrations do not reach the IC50 indicated by the
Caly et al. in vitro study, even for a dose level ten times higher than the approved dose, thus concluding
that a “likelihood of a successful clinical trial using the approved dose of ivermectin is low. Combination
therapy should be evaluated in vitro. Re-purposing drugs [. . .] is an ideal strategy but is only feasible
when product safety has been established and experiments of re-purposed drugs are conducted at clinically
relevant concentrations”.32
May 2020
On May 2, Aguirre Chang published a preprint of an observational case study of seven patients, showing
improvement and resolution of fever within 48 hours and a 100% recovery.33
On May 6, a randomized clinical trial of ivermectin for treatment and prophylaxis of COVID-19 (ECIT-
PRO19) was started Spain (EudraCT 2020-001994-66).34
On May 7, a peer-reviewed version of the Schmith et al. pharmacokinetic model simulations study was
published.32 On the same day, a pilot study to evaluate the potential of ivermectin to reduce COVID-
19 transmission (SAINT) by Chaccour et al. was started by University of Navarra in Pamplona, Spain
(EudraCT 2020-001474-29).35
On May 8, Peru adopted ivermectin country-wide.3
On May 11, in an editorially independent blog from the publishers of Science Translational Medicine, Lowe
discussed organic chemistry aspects of ivermectin.36
On May 15, a multi-center, randomized, double-blind, placebo-controlled study investigating efficacy, safety
and tolerability of ivermectin in patients with a proven SARS-CoV-2 infection (HUVE-19-CT-001) by Hu-
vepharma EOOD (Petkov) was started in Sofia, Bulgaria (EudraCT 2020-002091-12).37
On May 19, an Indian newspaper wrote about an observational trial by Alam et al. in Bangladesh, with
60 patients treated with a combination of ivermectin and doxycycline recovering within four days.38 Alam,
who was referred to as “a reputed clinician in Bangladesh”, said the combination “yielded virtually the near-
miraculous result in curing the patients” with no side effects. He mentioned being “a hundred per cent
hopeful about the effectiveness” and that they had contacted government regulators to prepare for national
and international adoption of the treatment.
On May 20, an observational early treatment outpatient study in Peru by Mogrovejo Ramos et al. with
63 symptomatic patients diagnosed through teleconsultations and prescribed 0.2 mg/kg ivermectin reported
that symptoms such as fever had significantly decreased at 24 hours, with sense of smell recovered and
discomfort overcome at 48 hours, while the cough and muscle aches remained on day 5.39 The authors
concluded that “a massive distribution of this drug with a prescription should be considered as a public
health strategy to be applied by the first-line establishments, in order to avoid overcrowding and collapse of
the national health system”.
On May 27, Rizzo suggested that ivermectin may have an ionophore role, thus introducing a possible new
mechanism of action.40
On May 31, another Indian newspaper referred to the results of the study by Alam et al. in Bangladesh,
saying that the Indian Council of Medical Research (ICMR), the country’s apex medical research body, is
reviewing the benefits of the combination. A senior ICMR researcher said the agency had reviewed ivermectin
multiple times and continued to study it, adding that “however, to conclude anything we would need solid
evidence or a published study, backed by statistically significant data on a bigger sample size”. The article
mentioned ivermectin being a part of at least five ongoing trials in India.41
June 2020
On June 1, to prevent outpatient deterioration and hospital congestion, the government of Peru launched
a ‘Territorial Aid Operation for Treatment and Isolation in Response to COVID-19’ (Tayta), consisting of
4
early outpatient treatment with individually prescribed combinations of paracetamol, azithromycin, hydrox-
ychloroquine and ivermectin.42
On June 2, a study about ivermectin as an antiviral treatment for patients infected by SARS-COV2
(CORIVER) was started by Hospital Universitario Virgen de las Nieves (Sergio Sequera) in Granada, Spain
(EudraCT 2020-001971-33).43
On June 2, Science wrote about Expressions of Concern (EOCs) posted by the Lancet and the New England
Journal of Medicine about two non-ivermectin studies based on the Surgisphere database.44 The two EOCs
led to temporary halting of many hydroxychloroquine studies unrelated to Surgisphere database. A researcher
involved in one of the halted studies commented that “the problem is, we are left with all the damage that
has been done . .. the whole world thinks now that these drugs are poisonous”.
On June 3, The Guardian (UK) wrote about “flawed data” from Surgisphere Corporation having prompted
the Peruvian government to add ivermectin to its national COVID-19 therapeutic guidelines.45,46 The story
described Surgisphere employees having little or no scientific background, saying a science editor appeared
to be a science fiction author and fantasy artist, and a marketing executive being an adult model and events
hostess. The article referred to a peer-reviewed hydroxychloroquine study published in The Lancet, based
on the same database, stating that seven hospitals “whose cooperation would have been essential for the
Australian patient numbers in the database to be reached . .. denied any role in such a database, and said
they had never heard of Surgisphere”. The ivermectin preprint based on the database was available on June
2 but no longer on June 3.29
On June 4, Science wrote about retractions of two peer-reviewed articles by Patel et al. published by The
Lancet and The New England Journal of Medicine that were not about ivermectin but based on the same
database compiled by Surgisphere Corporation.47 The Science article noted that the ivermectin study was
only posted online as a preprint and was no longer available but it was said to have prompted increased use
and government authorization of the drug in several Latin American countries. On June 8, Science wrote
about the backgrounds of the researchers involved in the Surgisphere scandal.48
On June 4, a Brazilian clinician Lucy Kerr described her ivermectin treatments, stating that “I decided to
use it on patients because the side effects are almost nonexistent and if it worked I would save a lot of lives.
Now I have more than 30 cases that I treated and cured. Many more were cured by doctors in the group of
570 doctors that I administer in WhatsApp and Telegram”.49,50
On June 7, a news report from Peru wrote that Arévalo and Hinostroza had treated 1,200 patients with
ivermectin “with excellent results” since April 14.27 Arévalo had initially treated prisoners, then the police
and later the residents in the community. The report said that the government had announced a plan to
acquire 490 000 doses. About the role of the WHO, Arévalo commented that “the WHO has made serious
mistakes that resulted in thousands of human deaths at the beginning of the pandemic, such as not replying
to the October 2020 letter from South Korea reporting atypical pneumonia in that region, the advice against
masks, the banning of ivermectin after promising results from two Australian researchers, as well as ten more
mistakes. After this pandemic we have to look back and restructure that organization”. About the lack of
evidence from large trials he said that “in this disease the only evidence we had was about the mechanisms
by which the patients died and trials of drugs that had little or no effect in the late phase of the disease . ..
the great discoveries in medicine have been based on observations, accidents and coincidences”. The report
also mentioned ivermectin treatments having been carried out in neighboring countries including Bolivia
commencing several weeks earlier, with good results.
On June 10, initial results of an observational controlled 280-patient ICON ivermectin trial were made
available as a preprint on medRxiv.51 The trial used propensity matching. Mortality was significantly lower
among ivermectin-treated patients with severe pulmonary involvement (38.8% vs 80.7%, OR 0.15, 95% CI
0.05-0.47, p=0.001). Among all ivermectin-treated patients, mortality was also lower in the ivermectin group
(13.3% vs 24.5%, OR 0.47, 95% CI 0.22-0.99, p<0.05).52
On June 12, Heidary et al. published a systematic peer-reviewed review of the antimicrobial, antiviral,
and anti-cancer properties of ivermectin.53 On the same day, TrialSite News wrote about early grassroots
experimentation with ivermectin in Peru.54
On June 12, a peer-reviewed article about case series of 100 patients treated with a combination of ivermectin
and doxycycline in Bangladesh by Alam et al. found the combination very effective in viral clearance in mild
and moderately sick patients, with all of them testing negative and symptoms improving within 72 hours.55
5
On June 12, a randomized double-blind multi-centre phase II proof of concept dose finding clinical trial
on ivermectin for the early treatment of COVID-19 (COVER) was started in Negrar di Valpolicella, Italy
(EudraCT 2020-002283-32).56,57,58
On June 13, a news article described “an avalanche of cases” in May 2020 in Iquitos, Peru, a lack of response
from the officials, and a successful containment of the initial epidemic by local doctors utilizing ivermectin
for early outpatient treatments.59 One of the doctors, Sergio Bardon, a neurosurgeon, occupational physician
and specialist in community and rural health trained at the University of Buenos Aires and the University of
Sheffield in the United Kingdom, described that ivermectin reduced viral loads, causing a drastic improvement
in the clinical representation of the patients. Bardon mentioned chaotic changes in the WHO and national
regulations, saying a ministerial resolution prohibiting the use of antibiotics and corticosteroids but allowing
ivermectin had just been issued. Bardon stressed the need for early treatment to prevent the patient going
into an inflammationary phase in which the viral load was not relevant any longer and in which “ivermectin
no longer makes much sense”. Bardon described the phase-specificity of COVID-19, including the stopping
of viral replication in a few days after the beginning of the symptoms, and the lack of efficacy of antivirals
in the inflammatory phase. Bardon said he had only needed to hospitalize his first COVID-19 patient, after
which he had been able to treat all the others as outpatients. He said he had also treated patients in Loreto,
Amazonas where there were no hospitals but all patients had been successfully treated as outpatients with
a combination of ivermectin and azithromycin. With regard to the hospital in Iquitos, Bardon added that
the internationally publicized immediate crisis with people dying outside the hospital had been solved a few
days later by administering single-dose injectable ivermectin, with Bardon participating in the process. The
problem was that pharmacies were becoming out of stock and the prices had multiplied by approximately
seven, from USD 4 to USD 30. Bardon stressed the importance of ensuring the supply. Many patients had
been unable to obtain the drug even though Brazil produced it nationally and it had initially been relatively
affordable. Even if the production had been sufficient the drug had not been properly distributed in the
areas in need. Also, the situation was worsening, with too many infected patients leading to a chaos in the
underresourced health care system.
On June 14, Sparavigna published an initial version of an ongoing review of the history of ivermectin in
COVID-19, describing, among other issues, the case of Iquitos, Peru. The review was continuously updated
up to July 29, then again updated on September 8 and September 20.60 On the same day, German weekly
magazine Der Spiegel wrote about the Surgisphere scandal.61
On June 15, a preprint discussed the role of CD147 transmembrane receptor in the binding of SARS-CoV-2
and mentioned treatments of 71 patients by Rajter in Florida had yielded a statistically significant reduction
in mortality, with fast reversals of rapidly deteriorating oxygen status.62,63,64
On June 17, a Japanese treatment manual listed ivermectin as one of the treatment options.65
On June 19, an in-silico analysis indicated ivermectin may interfere with SARS-CoV-2 spike attachment to
cell membrane.66
On June 21, an in vitro study by Zhang et al. concluded that ivermectin produces genotoxicity and cy-
totoxicity by inducing DNA damage and AMPK/mTOR-mediated autophagy, thereby posing a potential
risk to human health.67 The authors also warned that accumulation of ivermectin in animal tissues and the
excretion of urine and feces in the environment is a major source of potential toxicity.
On June 23, the Ministry of Health of Peru published instructions for making 6 mg/ml oral solution of
ivermectin.68
On June 24, Molento et al. published “a word of caution” against self-medication.69
On June 30, a peer-reviewed version of Caly et al’s in vitro study was published.19 On the same day, the
president of a company operating three hospitals and several outpatient clinics and other facilities in the
Dominican Republic, José Natalio Redondo, described their experience with off-label treatment of 1,300
patients with 0.1-0.4 mg/kg of ivermectin in conjunction with azithromycin, stating that 99% of them had
been cured within 8-10 days, the average duration of the full infection was reduced from 21 days to 10 days,
and the only side effects had been mild heart burn and diarrhea.70 Doctors from Mexico, Ecuador, Peru,
Bolivia, Brazil and a few other countries had formed a network for sharing protocols. Redondo mentioned
that the public healthcare has less flexibility and followed WHO, the US and other guidance based on
funding. He mentioned companies cannot profit off of a generic drug, adding that the priorities are wrong:
early treatment should have been prioritized. Redondo mentioned that Merck &Co/MSD had been in touch
with them at one point but the medicine used in the Dominican Republic had been produced by a local
6
company. Redondo stressed the importance of harm reduction by saying that “the health, economic and
social benefit of cutting 10 days out of the sickness and reducing the amount of time a person is contagious
. .. [it has had] a huge impact. A huge value to society. Look at what this pandemic has done to the global
economy! Look at New York City – the greatest city with per capital perhaps the greatest doctors and
health systems yet look at the amount of death and the impact. It is horrific; a tragedy”. With regard to
trials, Redondo commented that “it is very expensive to conduct clinical trials. In developed nations in the
Caribbean, Central and South America, countries in Africa and some in Asia we must act now to stop the
disease from progressing and spreading. We have an investigation we are in fact undertaking and there are
other good studies in the works from Johns Hopkins University to Sheba Medical Center in Israel. But those
will take some time. The network in Latin America and the Caribbean has acted on observational, off-label
data, and it is working. After all, over a trillion doses of ivermectin are given annually for fighting parasites.
It is an incredibly safe drug . .. The results speak for themselves”.
In June, country-wide ivermectin use begun in Bangladesh.3
July2020
On July 1, a preprint by Scheim hypothesized about alleviation of CD147 transmembrane receptor mediated
vascular occlusion with ivermectin.71
On July 2, Syed discussed studies by Caly et al. and Rajter et al. and the Dominican Republic experiences,
commenting that ivermectin appears useful in all stages of COVID-19 but should not be used in individuals
with a compromised blood-brain barrier.19,51,72
On July 7, the deputy director of the Bulgarian Center for Parasitic and Infectious Diseases described
ivermectin as “the most promising”, citing the long experience (1975 onwards) about it as a benefit, however
noting that there is a need to wait for results of its possible clinical efficacy in COVID-19.73 She also expressed
satisfaction that there was a company in Bulgaria that was ready to produce it.
On July 8, a small open-label pilot trial by Gorial et al. with 87 inpatients of which 16 treated with ivermectin
indicated a 42% lower mean hospital stay with a 0.2mg/kg single dose of ivermectin added to a standard
regime of hydroxychloroquine and azithromycin (7.62 vs 13.22 days, p=0.00005) (NCT04343092).74
On July 9, an in-silico docking and simulation study indicated that a combination of ivermectin and doxy-
cycline might inhibit viral entry and enhance viral load clearance by targeting various viral functional
proteins.75
On July 11, Aguirre-Chang et al. reported a high rate of clinical improvement in 33 patients with persistent
or post-acute symptoms treated with ivermectin.76 A complete remission of symptoms was observed in 87.9%
of the patients after two daily doses of ivermectin. An additional dose of ivermectin for the rest of the patients
resulted in a compete remission in 94% of cases.
On July 12, the BBC wrote about fake cures in Latin America, citing Pan American Health Organization
(PAHO), a regional office for the Americas under the World Health Organization (WHO).77 PAHO stated
ivermectin was being used “incorrectly .. . without any scientific evidence of its efficacy and safety”.
On July 14, a randomized controlled trial by Chowdhury et al. about early treatment of 116 patients compared
ivermectin-doxycycline and hydroxychloroquine-azithromycin. Times to symptomatic recovery were 5.93 days
vs 6.99 days, respectively, not indicating a significant difference.78
On July 15, Rajter and Cepelowicz-Rajter discuss their ivermectin experiences in Florida.79,80
On July 17, a letter to the editor by Peña-Silva et al. stated that there was no evidence that the 5 μM
concentration used in the Caly et al. in vitro study could be achieved in vivo.81 The authors stated that even
with the highest reported dose of approximately 1.7 mg/kg (8.5 times the FDA-approved dose of 0.2 mg/kg)
the maximum plasma concentration was only 0.28 μM. They also stated that 93% of ivermectin is bound
to plasma proteins which limits its cellular uptake by endothelial cells, thus the free plasma concentration
of ivermectin would be 250 times lower than the required concentration. In addition, it was suggested
to be unlikely that lung accumulation would be sufficient to achieve the antiviral effect with conventional
doses. Also the clinical effects of ivermectin at a concentration of 5 μM range were said to be unknown
and possibly associated with toxicity. In summary the authors suggested that ivermectin has in vitro
activity against SARS-CoV-2 but the effect is unlikely to be observed in vivo using current dosing. On the
7
same day, Arpornsuwan et al. presented a proposal for early diagnosis and management of COVID-19 with
ivermectin.82
On July 18 in India, a panel of senior doctors including Behera evaluated ivermectin and concluded it can be
a potential agent for prophylaxis and treatment of COVID-19, due to its antiviral properties, affordability,
availability and safety.83 The suggested dose was 12 mg BD. The panel recommended randomized controlled
trials.
On July 30, Aguirre-Chang et al. published a proposal on post-exposure prophylaxis with ivermectin.84
On July 30, Stauffer et al. presented a potential strategy to avoid potentially fatal steroid-related strongy-
loides hyperinfection.85 They reported that 10% to 40% of populations in tropical and subtropical regions
may be infected with a nematode causing strongyloidiasis. The estimated prevalences among immigrants
varied between 11% and 50%. The authors suggested either screening or presumptive treatment with iver-
mectin.
On July 31, a comparative study by Rahman et al. of 400 patients in Bangladesh compared ivermectin-
doxycycline and hydroxychloroquine-azithromycin, concluding that ivermectin-doxycycline was a safe and
effective combination for obtaining early viral clearance in mild to moderate COVID-19 patients.86
In July, the city of Cali in Colombia adopted ivermectin, with an initial distribution of 10,000 doses.87 The
decision was based on good results achieved in Guayaquil, Ecuador. Ivermectin was used in the early phase
to prevent progression of disease and subsequent hospitalization. It was distributed to all COVID-19 positive
patients and people suspected of exposure to the SARS-CoV-2 virus. The mayor of Cali stated that “we are
going to do it even if there is no consensus in the scientific community”.
August 2020
On August 1, state of Chiapas in Mexico adopted ivermectin.88
On August 6, an expert panel in Uttar Pradesh, India gave a recommendation for ivermectin prophylaxis
of health-care workers and COVID-19 contacts, and for ivermectin treatment of symptomatic patients, with
the exception of pregnant and lactating women, and children below 12 years.89
On August 11, interestingly, Pan American Health Organization’s (PAHO) update of potential therapeutics
still included two retracted preprints by Patel et al., in addition to Caly et al. in vitro study, and studies by
Rajter et al. and Gorial et al., concluding that the evidence is unconvincing.90
On August 13, The Guardian wrote that “world-leading parasite researcher Dr Carlos Chaccour says using
the drug in fight against the virus could be ‘very, very harmful’”, warning against Australia adopting the
drug without proper evidence.91
On August 14, a peer-reviewed observational retrospective late treatment study by Battacharya et al. in
Kolkata, India indicated that a triple therapy with ivermectin, N-acetylcysteine and atorvastatin for 148
patients resulted in an in-hospital mortality rate of 1.35% which was well below the national average.92
On August 14, Lier et al. reported a complicated case of disseminated strongyloidiasis in a patient with
severe COVID-19 requiring ventilation.93
On August 15, a peer-reviewed early treatment study by Espitia-Hernandez et al. in Mexico with 28 treated
patients and 7 controls indicated that ivermectin, azithromycin and cholecalciferol reduced viral positivity
by 97% at day 10 and the mean duration of symptoms from ten days to three days.94
On August 15, an Australian new article described a triple therapy with ivermectin, doxycycline and zinc
by Borody as effective, adding that “other than Borody, almost nobody in Australia is treating patients
with ivermectin .. . at first glance, it seems inexplicable . .. the safety profile is so well-known that there
is virtually no risk. There are already 33 clinical trials running around the world. The results so far are
uniformly positive”.95,96 The article concluded that “medical litigation has created an ultra-cautious culture
even when there is virtually no risk, and second, doctors are mostly imprisoned in the prevailing paradigm
which holds that there is no effective treatment to cure Covid-19 and that the only way out of Australia’s
pandemic penitentiary is a vaccine .. . a vaccine for a coronavirus should never have been Plan A for anyone
as a way out of a pandemic .. . it is extraordinary how little thought has been given to an effective cure
. .. in part that’s because the only drug, other than ivermectin, that has shown promise as a prophylactic,
an anti-viral and in dampening down Covid’s fearful cytokine storm is hydroxychloroquine, which has been
8
demonized both by Big Pharma and by US Democrats. It is now an article of faith on the Left that
it doesn’t work, despite remarkable results at some of America’s leading hospitals and support from Ivy
League academics”.95
On August 21, a second preprint of the observational ICON study by Rajter et al. in Florida, USA indicated
mortality rates of 12.4% vs 25.8% (OR 0.41, CI 0.19-0.87, p=0.02) with and without ivermectin, respectively,
in a propensity-matched cohort of 194 patients.97 As stated earlier, mortality was significantly lower among
ivermectin-treated patients with severe pulmonary involvement (38.8% vs 80.7%), although this result had
been observed before corticosteroid use became more widespread.
On August 22, capital city of Lucknow in Uttar Pradesh, India, adopted ivermectin.88
On August 27, the National Institute for Health (NIH) of the United States gave a recommendation on
ivermectin, advising against using it except in clinical trials.98 The FLCCC group noted the recommendation
was rated A III, i.e. a strong recommendation based on expert opinion only.88 The rating implied that there
was no available evidence at the time to make an “evidence-based” grading (in quality of evidence for
recommendation classes I, IIa and IIb). However, the results of the ICON trial were available, indicating a
possibility for a class IIa or IIb recommendation.51
On August 27, Shouman et al. posted results of a randomized clinical trial in Egypt about prophylactic
ivermectin treatment of family members of COVID-19 outpatients, indicating that 7% of treated were infected
vs 58% in the control group (NCT04422561).99,100
On August 27, MedPage Today mentioned the Australian study, use of ivermectin in Peru and Bolivia, com-
menting that “although the drug is relatively safe, some scientists are worried that clinicians are putting the
cart before the horse”, and quoted Chaccour emphasizing the need for scientific rigor and the possibility of
side effects.101 The article mentioned the FDA warning cautioning against the use of veterinary formulation
of ivermectin, mentioning it was presumably intended “to protect the public against misinformation, after a
man died in March from consuming chloroquine phosphate, an aquarium cleaner, when hydroxychloroquine
(HCQ) was making headlines”, adding that “however, in doses used off-label for scabies, for example, iver-
mectin has a low side-effect profile”. The article then mentioned “positive signal in Florida” interviewing
Rajter about his early experience in April 2020, who mentioned that “the success story we had in early April
has been duplicated in other smaller studies across the world”. Two other researchers commented that the
studies were difficult to interpret and saw parallels to hydroxychloroquine studies. The article also referred
to the Surgisphere scandal, positive findings from India, and a triple therapy with ivermectin, doxycycline
and zinc by Borody, ending with comments by Chaccour that “the drug should not be written off, but neither
is it ready for widespread clinical use” and by Rajter that he is “frustrated by an intentionally slow review
process . .. certain drugs are expedited by the FDA, while other treatments which have been shown to be
quite effective – like ivermectin – have not seen the light of day”, and an Italian researcher commenting
that “it’s a shame that so few randomized controlled trials have been performed in the U.S. on potential
treatments such as this one”.
On August 27, a news story described mass ivermectin distribution of 1.5 million pills in the city of Itajaí in
Brazil organized by the city’s mayor (who was also a medical doctor) as a “pseudo-health”, “a magic potion
to circumvent what scientific evidence is showing”, “irrational and reckless” and a “national joke”.102 An
infectious diseases consultant commented that ivermectin had “sparked an ideological war .. . no one speaks
the same language anymore”.
September 2020
On September 3, an open-label randomized controlled study by Podder et al. in Bangladesh with 62 mild to
moderate patients did not produce statistically significant results.103
On September 6, state of Alto Parana in Paraguay adopted ivermectin.88
On September 10, Marchese et al. in Italy reported a case of strongyloidiasis after eleven-day treatment with
high-dose corticosteroids and tocilizumab for severe COVID-19, with a 4-day course of ivermectin leading
to full recovery.104
On September 11, Elkholy et al. proposed that inhaled ivermectin could attain the desired lung concentration
rendering it effective against SARS-CoV-2.105
9
On September 14, Manikappa suggested a quadruple therapy involving ivermectin, doxycycline, zinc and
vitamin D3for both prophylaxis and treatment.106
On September 15, an article by Jans et al. reviewed the existing data on broad-spectrum antiviral effects of
ivermectin, writing that “an instinctive response in developing antiviral agents is to strive for high specificity
since ideally they don’t impact host function. However, viral genomes of RNA viruses have a high propensity
to mutate. Host-directed agents that impact host cellular pathways utilized by many viruses may largely
circumvent the problem of development of viral resistance and have true potential to be broad-spectrum
antivirals”.4
On September 15, a preprint by Carvallo et al. described an early treatment prospective trial of ivermec-
tin, dexamethasone, enoxaparin and aspirin in Argentina with 167 patients, indicating a mortality rate of
3% in hospitalized cases in study vs 25% cases in the same hospital not in the study (RR 0.12, p=0.05)
(NCT04425863).107,108,109
On September 20, Sparavigna’s review was updated.60 Among other issues it mentioned that the reason for
continuing high mortality in Peru was self-medication with corticosteroids in the early phase, with these
patients being hospitalized in worse condition than patients who had not self-medicated.110 The review also
suggested that it was not possible to separate the effect of ivermectin among widespread self-medication with
ivermectin, chloroquine, hydroxychloroquine, azithromycin and a “famous triple” consisting of piperacillin-
tazobactum, metamizole and intramuscular dexamethasone.
On September 22, a study by Li et al. was the first to provide ivermectin-regulated virus-related path-
ways by SILAC quantitative proteomics analysis, which revealed a broad-spectrum antiviral property of
ivermectin.111 The 52 identified ivermectin-regulated proteins included some reported SARS-CoV-2 related
proteins, which the authors suggested could assist in exploiting potential ivermectin-related biomarkers and
the novel mechanisms in the treatment of SARS-CoV-2 infection.
On September 24, a retrospective late treatment study by Khan et al. with 115 ivermectin-treated patients
and 133 controls indicated a mortality rate of 0.9% vs 6.8% (RR 0.13, p<0.05) and 73.3% lower time to viral
clearance (relative time 0.27, p<0.001).112
On September 24, Tilli et al. warned that even low-dose corticosteroids may induce a strongyloidiasis
hyperinfection and dissemination with very high fatality rate, suggesting that immigrants and elderly patients
should be either screened for strongyloidiasis or presumptively treated with ivermectin when treatment with
steroids is imminent.113
On September 30, a peer-reviewed randomized controlled late treatment study by Chachar et al. with 25
ivermectin-treated patients and 25 controls did not produce a statistically significant result.114 On the same
day, the Dominican Republic adopted ivermectin country-wide.3
October 2020
In the beginning of October, Chamie published a preprint reviewing the epidemiological “real-world” evidence
of the effect of ivermectin mass distribution in Peru on COVID-19 excess deaths in the population older
than 60 years.115
The data was presented also on TrialSite News on October 5.116 The article commented that “the Peruvian
government approved the use of ivermectin by decree on May 8. Despite having received several requests
to suspend it in September . .. the new Minister of Health ratified it. These measures have aroused much
criticism among the scientific community. They do not understand why [Peru] continues to distribute the
antiparasitic drug without having a randomized blind study to prove its effectiveness and overlook that the
total death toll from COVID-19 in Peru is one of the world’s highest”.
On October 8, an in silico study by Frances-Monerris et al. indicated that a wide spectrum of actions of
ivermectin involving interference with cell infection, inhibition of viral replication and elusion of the host
immune system could point to an unprecedented synergy between host- and virus-directed effects explaining
the observed high anti-SARS-CoV-2 activity.117
On October 8, a retrospective database study about late treatment by Soto-Becerra et al. in Peru indicated
no beneficial effect from ivermectin.118,119 The CovidAnalysis group and others criticized the methodology
of the study.120,121
10
On October 9, a preprint of a randomized controlled late treatment study by Mahmud et al. (NCT04523831)
with 183 patients in the treatment group and 183 controls indicated 49% lower risk of no recovery (23%
vs 37.2%, RR 0.51, p<0.004), 55% lower risk of disease progression (8.7% vs 17.8%, RR 0.45, p<0.01) and
42.0% lower risk of no virological cure (7.7% vs 20.0%, RR 0.58, p<0.001).122,123
On October 10, states of Uttar Pradesh in Northern India with a population 210 million people and the
state of Goa on the Southwestern coast of India with a population of 1.5 million people adopted early home
treatment kits which include ivermectin.88,124
On October 11, Kant et al. from Uttar Pradesh published a review of ivermectin describing the Uttar Pradesh
treatment model of prophylaxis for contacts: 0.2 mg/kg on days 1 and 7, and prophylaxis for healthcare
workers: 0.2 mg/kg on days 1, 7 and 30, followed by monthly for six months. The total cost of ivermectin
treatment of COVID-19 patients was USD 15 for 12 mg BID for 3-7 days; it was used in combination with
doxycycline.125 Earlier on September 20, Medtalks had published an interview of the researchers.126
On October 12, Scheim hypothesized that ivermectin may limit virulence of SARS-CoV-2 by steric interfer-
ence with multivalent spike protein attachments to sialic acid binding sites, blocking hemagglutination, an
effect likely to target mutant viral strains.127
On October 12, the Ministry of Health of Peru retracted the ivermectin recommendation for hospitalized
patients.128 Distribution in many outpatient clinics continued.
On October 13, final results of the 280-patient retrospective late-treatment ICON study by Rajter et al.
were published in the journal Chest, indicating 13.3% vs 24.5% total mortality (OR 0.47, 95% CI 0.22-0.99,
p=0.045) and 32% vs 81.8% mortality in severe disease (OR 0.27, 95% CI 0.08-0.92, p=0.002).51,52
On October 15, a Peruvian newspaper reported on a controversy about the Ministry of Health first allow-
ing treatment of hospitalized patients with hydroxychloroquine, azithromycin and ivermectin in May, then
disallowing them in October.129 The news report pointed to a local study indicating no benefit from iver-
mectin and harm from hydroxychloroquine-azithromycin combination in hospitalized patients. Apparently,
the change only concerned inpatients, not outpatients, for which self-treatment kits had been distributed
since May.
On October 18, a trial in Sofia, Bulgaria was completed (EudraCT 2020-002091-12).37
On October 19, a study about prophylaxis of healthcare workers with ivermectin and carrageenan by Carvallo
et al. (IVERCAR, NCT04425850) with 131 treated and 98 controls indicated a 96.3% reduction in infections
(0% vs 11.2%, RR 0.04, p<0.001).130,131 Carvallo later reported that carrageenan is not necessary.132
On October 22, a review of ivermectin use in Africa by Guerrero et al. estimated a 28% lower COVID-19
mortality in African countries using ivermectin for control of onchocerciasis vs African countries not using
it (RR 0.72, 95% CI 0.67-0.78).133,134
On October 26, a randomized controlled late treatment study by Hashim et al. in Iraq (NCT04591600) with
70 patients treated with ivermectin and doxycycline and 70 controls indicated mean times to recovery of
6.3 vs 13.7 days in patients with mild or moderate disease (p<0.0001) and 10.6 vs 17.9 days for all patients
(p<0.0001).135,136
On October 28, Gupta et al. published a study about the binding mechanism of ivermectin, identifying
RNA-dependent RNA polymerase (RdRp), an enzyme that catalyzes the replication of RNA from an RNA
template, as the most probable target for ivermectin.137
On October 30, the Front Line COVID-19 Critical Care Alliance (FLCCC) published an ivermectin-based
I-MASK+ protocol for prophylaxis and early outpatient treatment of COVID-19.138,139 According to the
authors, ivermectin was considered the first agent effective for both prophylaxis (prevention) of COVID-19
and for treatment of all phases of COVID-19 including outpatient treatment of the early symptomatic phase.
Ivermectin was also upgraded from an optional component to an essential component of the group’s MATH+
inpatient protocol which was later renamed to I-MATH+ protocol.
On October 31, a preprint by Chang et al. described ivermectin pre-exposure prophylaxis of 129 persons,
indicating a dose and dosing interval dependent prophylactic responses between 90% and 100%.140
Off-label use of ivermectin for COVID-19 begun in some regions of the US by the end of October,
with the total prescription count of ivermectin multiplying approximately six-fold.3A Reddit channel
/r/covidlonghaulinfo was founded.141
11
November 2020
On November 3, a matched case-control study by Behera et al. in India with 41 cases and 76 controls about
ivermectin prophylaxis of healthcare workers using two doses of 0.3 mg/kg on days 1 and 4 indicated a 73%
reduction in infections in the following month (p<0.001).142,143
On November 3, a peer-reviewed article by Morgenstern et al. in the Dominican Republic described a retro-
spective observational study about early treatment with ivermectin and azithromycin.144 2,706 outpatients
with mild infection were treated with a single dose of 0.4 mg/kg ivermectin and 500 mg of azithromycin for
five days. The average delay between the onset of symptoms and the initiation of treatment was 3.6 days.
Sixteen (0.59%) later required hospitalization without ICU care. Two (0.08%) required hospitalization with
ICU care, of which one (0.04% of total) died.
On November 4, a preprint describing an open-label observational prospective study by Cadegiani et al.
about early outpatient treatment of 110 patients and 137 controls (a group of paired untreated patients
randomly obtained retrospectively from the COVID-19 patient population of the same community) with 0.2
mg/kg/day of ivermectin for three consecutive days indicated 98.0% lower risk of hospitalization (0% vs
19.7%, RR 0.02, p<0.001) and 94.2% lower risk of ventilation (0% vs 6.6%, RR 0.06, p=0.005).145,146,147
On November 6, Carvallo said in an interview that after publication of the results (IVERCAR, NCT04425850)
in Argentina, the group met resistance from many doctors working in the pharmaceutical industry, likely
due to the too low cost of treatment, approximately USD 2 per day.132 He also stated that at that time,
half of Argentina’s states had adopted ivermectin protocols by decisions by local governments, with the rest
of the states working on adoption. According to Carvallo, the protocols were also used in Chile, Paraguay,
Bolivia, Southern Brazil, Peru, Venezuela, Colombia, Equador, Costa Rica, the Dominican Republic and
Honduras. He also commented that “for those who follow the WHO, it’s like blind person following another
blind person, because WHO has committed so many mistakes that we sometimes wonder whether WHO
has doctors in its staff, because the mistakes they have made are really blunders, and it’s impossible to
believe that experienced people working in an international organization like WHO could commit so many
mistakes”.
On November 6, in France, a criminal lawyer representing the Association of COVID-19 Coronavirus Victims
in France pleaded in favor of ivermectin before an administrative tribunal, asking for temporary permit.
Neither a representative of the Ministry of Health nor the national drug agency was present at the hearing.
The request was rejected by the judge.148
On November 10, a preprint by Turkia briefly reviewed the early history of the FLCCC Alliance protocols,
suggesting that ivermectin should be used based on existing data suggesting significant benefits, and that
waiting for additional data may result in significant harm.149,150
On November 11, a preprint indicated that 0.6 mg/kg/day for five days was well tolerated
(NCT004381884).151 A significant difference in reduction in viral load was found in patients with higher
median plasma ivermectin levels (72% IQR 59–77) versus untreated controls (42% IQR 31–3) (p=0.004).
The mean ivermectin plasma concentration levels also showed a positive correlation with viral decay rate
(r=0.47, p=0.02).
On November 11, a peer-reviewed retrospective study by Camprubi et al. with 13 treated patients and 13
controls about late treatment of severe disease with 0.2 mg/kg ivermectin plus hydroxychloroquine initiated
a median of 12 days after symptoms did not indicate a statistically significant result, leading the authors
to suggest a trial with a larger dose.152,153 On the same day, a podcast described Brazilian distribution of
ivermectin.154
On November 13, a preprint by Elgazzar et al. of a randomized controlled prophylaxis trial with a group
including healthcare workers (pre-exposure) and outpatients’ family members (post-exposure) with 100 mem-
bers in total, compared to 100 healthcare workers and family members using only standard personal protec-
tive measures (hand hygiene, social distancing measures, avoiding touching the eyes or nose, and face masks,
gloves, respiratory etiquette and self-isolation). The prophylaxis group received a single dose of 0.4 mg/kg
ivermectin at days 1 and 8. The results indicated infection rates of 2% vs 10%, i.e. 80% lower risk of infec-
tion (RR 0.20, p=0.03).155,156 The same preprint included results of a late treatment randomized controlled
trial comparing ivermectin and relatively low dose of hydroxychloroquine indicated a 50% reduction in time
to viral clearance and a substantially lower risk of death, although the effect of hydroxychloroquine in late
treatment is inconsistent and it may increase mortality.
12
On November 13, an initial version of a preprint by the FLCCC group was posted on osf.io.157 The preprint
included a brief meta-analysis of mortality data from three observational studies (Rajter et al, Khan et al,
Gorial et al; OR 0.48, 95% CI 0.27-0.84, p=0.011) and two randomized controlled studies (Mahmud et al,
Hashim et al; OR 0.26, 95% CI 0.06-1.09, p=0.065), indicating a statistically significant overall mortality
benefit (OR 0.44, 95% CI 0.26-0.75, p=0.002). The report also cited a study by Chamie that compared
one state in Paraguay with mass distribution of ivermectin to three states without distribution, showing a
reduction in case counts and deaths, and Chamie’s similar study about reduction of excess deaths of over 60
year olds in Peru.
On November 14, a peer-reviewed late-treatment prospective trial in India by Spoorthi et al. with 50 treated
patients and 50 controls using ivermectin (a single dose of 0.2 mg/kg) and doxycycline combination indicated
a 15.5% lower hospitalization time (relative time 0.84, p=0.01) and 21.1% lower recovery time (relative time
0.79, p=0.03).158,159
On November 17, a peer-reviewed report of a prophylaxis study (IVERCAR, NCT04425850) in Argentina
by Carvallo et al. with 788 healthcare workers and 407 controls indicated 0 (0%) vs 237 (58.2%) cases
of COVID-19, respectively (99.9% lower risk of infection, RR 0.001, p<0.001).160,161 The reported dosing
regime was one drop of ivermectin-containing liquid orally five times a day (every four hours) for 14 days,
with food and liquids avoided for one hour before and after treatment. The dosing regime amounted to 12
mg per week. Hirsch and Carvallo also published an updated prophylaxis protocol.162
On November 17, Facebook begun removing ivermectin-related posts by the FLCCC Alliance, stating that
they did not follow Facebook’s community standards.163
On November 18, an updated version of a preprint by the FLCCC group added a randomized controlled trial
by Elgazzar et al. to the meta-analysis, with three randomized controlled studies indicating a statistically
significant overall mortality benefit (OR 0.14, 95% CI 0.05-0.39, p<0.001), larger than the observational
studies or the overall result (OR 0.36, 95% CI 0.21-0.59, p<0.001).157
On November 18, a retrospective late treatment study in India by Budhiraja et al. of 34 ivermectin-treated
patients and 942 controls indicated a 99.1% lower risk of death (0% vs 10.9%, RR 0.009, p=0.04).164,165
On November 19, in an US Senate hearing, George C. Fareed, a Harvard professor with a background in
virology research at NIH, witnessed about usefulness of an early outpatient treatment with hydroxychloro-
quine, zinc and ivermectin.166,167 A group called CovidAnalysis had earlier published a meta-analysis of
nine randomized controlled trials about early, pre-exposure prophylaxis, or post-exposure prophylaxis treat-
ment with hydroxychloroquine, stating that all trials reported positive effects with an average of 30% risk
reduction (RR 0.70, 95% CI 0.53-0.93, p=0.002).168
On November 24, the New York Times published an opinion by Brown University dean Jha, another witness
at the November 19 US Senate hearing. In the opinion, Jha called other witnesses including Fareed “snake
oil salesmen” and the hearing a “misinformation super-spreader event”.169
On November 24, a preprint about a late treatment randomized controlled trial by Niaee et al. with
180 hospitalized patients with ivermectin but all patients receiving also a low dose of hydroxychloroquine
indicated dosing-dependent reductions in risk of death between 45.5% and 94.3%.170,171
On November 25, the Wall Street Journal published an article about too much caution killing COVID-
19 patients, saying doctors should follow the evidence for promising therapies but “instead they demand
certainty”.172 The article stated that “fear and panic are central impediments to competent decision-making
during a crisis . .. [creating] an air of inevitability, as if politicians have no choice but again to restrict
civil liberties, limit social gatherings, and cripple businesses that survived the initial lockdowns. But there’s
a better way: following the evidence for early treatment of Covid-19 .. . The health system would be
less burdened if more patients were treated before they require hospitalization, and there are promising
therapeutic options that patients can administer themselves at home. This was the subject of a Nov.
19 hearing before the Senate Homeland Security and Governmental Affairs Committee. Testimony from
the hearing underscored an important issue: Too many doctors have interpreted the term ‘evidence-based
medicine’ to mean that the evidence for a treatment must be certain and definitive before it can be given to
patients. Because accusing a physician of not being ‘evidence based’ can be a career-damaging allegation,
fear of straying from the pack has prevailed, favoring inertia and inaction amid uncertainty about Covid-
19 treatments .. . when options are limited and there are safe treatments with evidence for effectiveness,
holding out for certainty can be catastrophic”.
13
On November 26, the CovidAnalysis group published a random-effects meta-analysis of 21 existing ivermectin
studies at the website ivmmeta.com, indicating an overall 75% reduction in the effect measured (death,
hospitalization, etc.) (RR 0.25, 95% CI 0.16-0.40, p=0.00000048),173 and 60% reduction in twelve late
treatment studies (RR 0.40, 95% CI 0.24-0.66, p=0.00024). Eight randomized controlled trials indicated a
72% risk reduction (RR 0.28, 95% CI 0.13-0.59, p=0.0039). All 21 studies reported positive effects, indicating
a consistent effect in all stages of COVID-19.
On November 26, Syed discussed the mechanisms behind ivermectin’s action against SARS-CoV-2, also
introducing the I-MASK+ protocol.174,175,176,177,178,179
On November 28, a peer-reviewed statistical analysis of ivermectin prophylaxis by Hellwig et al. compared
African states with ivermectin mass distribution to African states without distribution, concluding that mass
distribution is associated with lower COVID-19 incidence and that prophylaxis could help bridge the time
until a vaccine becomes widely available.180
On November 28, a peer-reviewed retrospective study in France by Bernigaud et al. described a case of 69
residents of a care home with a median age of 90, treated with ivermectin for scabies outbreak, with seven
(10.1%) later diagnosed with probable or certain COVID-19, with no serious cases and no deaths.181,182 In
residents in comparable care homes there were 22.6% infections and 5% deaths. The CovidAnalysis group
calculated 99.4% lower risk of death (0% vs 4.9%, RR 0.006, p=0.08) and 55.1% lower risk of infection
(10.1% vs 22.6%, RR 0.45, p=0.01).
On November 30, Egypt adopted ivermectin country-wide.3
December 2020
On December 1, preliminary results of an early treatment observational study in Argentina by Alonso et
al. with 311 patients treated with ivermectin and 128 controls indicated 91.8% lower risk of death with one
(0.3%) deaths in the treatment group vs five (3.9%) in the controls (RR 0.08, p=0.009).183
On December 2, a peer-reviewed randomized controlled trial by Ahmed et al. with 72 patients treated with
5-day course of ivermectin indicated a 42.5% lower risk of no virological cure at day 7 (50% vs 87%, RR
0.58, p=0.01) and a 62.7% lower risk at day 14 (22.7% vs 60.9%, RR 0.37, p=0.02).184,185
On December 3, Chamie posted a diagram of an analysis on Twitter, suggesting that distribution of iver-
mectin home treatment kits since July 2020 in the state of Chiapas had resulted in lower mortality in that
state, compared to states without home treatment kits.186,187,188
On December 4, the FLCCC Alliance organized a press conference, urging the NIH and CDC to immediately
review the research evidence that had appeared after the NIH’s September guideline, to allow early outpatient
treatment. The alliance suggested that widespread, immediate use of ivermectin “would allow for a rapid
and safe reopening of businesses and schools across the nation and quickly reduce the strain on overwhelmed
hospitals and ICUs”.189
On December 7, a preprint of an early treatment double-blind randomized controlled trial (SAINT) in Spain
by Chaccour et al. with 12 patients treated with a single dose of 0.4 mg/kg ivermectin and 12 controls
indicated 52.9% lower risk of unresolved symptoms at day 28 (RR 0.47, p<0.05) but no difference in the
primary outcome (the proportion of PCR positives), for which the trial was labeled negative by many
commentators.190,191
On December 7, the New York Times wrote that an upcoming December 8 US Senate panel had been
transformed into “a forum amplifying dubious theories and questionable treatments pushed by President
Trump”, adding that two witnesses “promote the use of ivermectin, a drug often used to fight lice and
pinworms, to treat coronavirus patients, despite the National Institutes of Health’s recommendation against
its use outside clinical trials”.192 A democrat senator feared that the witnesses would “amplify theories that
are at odds with the broader scientific community and, according to experts, could cause harm” and that
“these fringe views run counter to what the Senate should be doing — working on a bipartisan basis to
protect the American people and tackle this deadly pandemic”.
On December 8, the Front Line COVID-19 Critical Care Alliance (FLCCC) president Pierre Kory gave a
testimony to US Senate Committee on Homeland Security and Governmental Affairs about the state of
ivermectin research.193
14
On December 9, a post on FLCCC Alliance Facebook page commented that “we are thrilled to be back with
you after a three-day stint in Facebook jail for writing the name of a component of our I-Mask+ Prophylaxis
and Early Outpatient Treatment Protocol on our Sunday post”. The post also gave a link to YouTube video
of Pierre Kory’s testimony on December 8. Facebook issued a warning that further mentions of ‘ivermectin’
would result in a permanent deletion of the FLCCC page. Later posts on the page referred to the ‘i-word’
and referred readers to the group’s website and Twitter for further information.
On December 11, a peer-reviewed early treatment case series study in Bangladesh by Hussain et al. with 8
patients resulted in all patients testing negative by day six.194,195
On December 11, an article by Associated Press, “a part of The Associated Press’ ongoing effort to fact-
check misinformation that is shared widely online, including work with Facebook to identify and reduce the
circulation of false stories on the platform”, discussed Kory’s Senate Committee testimony mentioning it
had received one million views on YouTube, and referring to comments by two infectious disease experts
it concluded that “there’s no evidence ivermectin has been proven a safe or effective treatment against
COVID-19”.196
On December 12, a post on FLCCC Alliance Facebook page noted that YouTube had taken down the video
of Kory’s US Senate Committee testimony. On December 14, another post commented that the group’s
repeated attempts to reach out to US health authorities including NIH, CDC and FDA in order to discuss
the information given in the Senate Committee testimony had failed.
On December 15, a preprint of an 95-patient early treatment study in Pakistan by Afsar et al. with all
patients receiving a low dose of hydroxychloroquine an azithromycin and the treatment group also receiving
ivermectin indicated 92.2% lower risk of fever at day 14 (0% vs 13.2%, RR 0.08. p=0.04).197,198
On December 15, a peer-reviewed observational prophylaxis study in Bangladesh by Alam et al. with 118
healthcare workers, of which 58 received 12 mg ivermectin monthly, indicated 90.6% lower risk of infection
(6.9% vs 73.3%, RR 0.09, p<0.001).199,200
On December 17, the National Institutes of Health published an update to their guideline on prevention and
prophylaxis of SARS-CoV-2 infection.201 The panel gave a strong recommendation based on expert opinion
only (class A III), recommending against the use of any agents in either pre-exposure or post-exposure
prophylaxis, except in clinical trials. Ivermectin was not mentioned in the recommendation.
On December 18, a preprint by Kory et al. presented a meta-analysis of one observational prophylaxis
studies (OR 0.06, 95% CI 0.03-0.11) and three randomized controlled prophylaxis studies (OR 0.13, 95% CI
0.07-0.22).202
On December 18, Belize adopted ivermectin country-wide for serious cases.203,3,88
On December 18, MedinCell announced that a continuous administration over a one-month period to healthy
volunteers confirmed ivermectin’s safety up to a daily dose of 75 μg/kg (NCT04632706).204,205 A news report
commented that “as the vaccines won’t solve all of the short -term potential problems with COVID-19 the
challenge is that at least thus far government agencies in wealthy GPD nations show little to no interest in
such repurposed, generic drug responses”.206
On December 20, a preprint of a prophylaxis study in Argentina by Vallejos et al. with 389 treated patients
and 486 controls indicated 73.4% lower risk of COVID-19 case (3.3% vs 12.6%, RR 0.27, p<0.001).207,208
On December 21, a news report described a late stage treatment experiment just initiated by professor
Cacopardo in Sicily, Italy, with results not yet available.209
On December 23, Macedonia adopted ivermectin country-wide.3
On December 23, Merck & Co/MSD announced it had entered into agreement with the United States
Government to develop, manufacture and distribute a biological therapeutic MK-7110 upon approval or
emergency use authorization from the FDA.210 The company was to receive USD 356 million for supply of
60,000-100,000 doses of MK-7110 for US Government through June 30, 2021 (apparently indicating a price
of USD 3,560.00-5,933.00 per dose). An interim analysis of 203 participants (75% of planned enrollment) of
a phase 3 study evaluating MK-7110 for severe and critical COVID-19 indicated that a single dose showed
a 60% higher probability of improvement and a more than 50% reduction in risk of death or respiratory
failure.
15
On December 24, a Macedonian newspaper wrote that the drug agency MALMED is going to approve
ivermectin for COVID-19 in Macedonia.211 The price was said to be 12 euros (USD 14) per 12 mg. Ivermectin
was said to be an integral part of hospital protocols in Bulgaria already, utilized by for example professor
Ivo Petrov at Acibadem City Clinic in Sofia, Bulgaria. Petrov commented when ivermectin is applied in the
first few days after the onset of symptoms they resolve significantly faster and oxygenation is required less
often. Petrov was also taking ivermectin for personal prophylaxis.
On December 24, a Facebook post by the FLCCC group commented that “the Associated Press refuses to
retract its article saying there is no evidence that the medicine we cannot name on FB can prevent or treat
COVID-19. To suppress this information is to bless a massacre that can be stopped.”
On December 24, a South African newspaper wrote that import ivermectin into South Africa had been
declared illegal by the South African Health Products Regulatory Authority (SAHPRA). Its chief executive
stated that “our stance is unambiguous. This drug is not approved by SAHPRA and any attempt to import
it into the country will be dealt with by SAHPRA’s regulatory compliance unit in conjunction with law
enforcement agencies .. . SAHPRA is focused on quality, safety and efficacy and its ultimate goal is to
protect the health and well-being of all those who live in South Africa”.212
On December 25, a Facebook post by the FLCCC group commenting NIH’s December 17 guideline update
stated that “the refusal of the NIH to cite or even acknowledge the irrefutable evidence in our scientific
manuscript means that tens of thousands of Americans will now go to their early graves. This is an uncon-
scionable and murderous declaration not based in science or the medical facts .. . When history is written
about how the NIH inexplicably placed the citizens it was impaneled to protect in harm’s way, we will weep
bitter tears at the words on the page”.
On December 27, Hill et al. published a YouTube video “Ivermectin meta-analysis by Dr. Andrew Hill”
giving out initial results of a WHO-funded meta-analysis.213 The presented conclusions were as follows: “In
this meta-analysis of 11 randomized trials in 1452 patients, ivermectin treatment was associated with: faster
time to viral clearance, shorter duration of hospitalization, 43% higher rates of clinical recovery (95% C.I.
21-67%), 83% improvement in survival rates (95% C.I. 65-92%)”. The video was branded with University of
Liverpool, Access to COVID Tools Accelerator and Unitaid logos. Unitaid is a global health agency hosted
by the World Health Organization.214 The Access to COVID Tools Accelerator is a partnership of the Bill
& Melinda Gates Foundation, CEPI, FIND, Gavi, The Global Fund, Unitaid, Wellcome, WHO and the
World Bank.215 On February 26, 2021, the link lead to a notice “This video has been removed for violating
YouTube’s Terms of Service”.
On December 27, without warning or explanation, Twitter deleted the account of the CovidAnalysis group
which had provided meta-analyses of randomized controlled trials on various proposed treatment agents for
COVID-19, including ivermectin, vitamin D, hydroxychloroquine and zinc.216 However, the FLCCC Alliance
was allowed to tweet about ivermectin, and in December 2020 it routinely referred people from its Facebook
page to its Covid19Critical Twitter account for news and updates about its ivermectin protocols.
On December 28, in France, a preliminary filing was forwarded to the minister of health and to the national
medicines agency, requesting a temporary recommendation.148
On December 30, a review by McCullough et al. stressing the need for early outpatient treatment with
a sequential multi-drug treatment algorithm mentioned home-based treatment kits with ivermectin having
been distributed in Argentina, Bangladesh, Colombia, India, Mexico and Peru.217
On December 31, a peer-reviewed version of the brief review of the early history of the FLCCC Alliance was
published.138
On December 31, a peer-reviewed study by Madrid et al. investigating safety of ivermectin in a fish model
stated that high doses of 0.22 and 0.86 mg/kg were not harmful to the intestinal tissues of the animal model
neither affected the blood cells counting in general.218 An overdose of 170 mg/kg (10.2 g for a 60 kg person) in
increased expression of the Myosin-Vb which may have implications in the intestinal epidermal integrity.219
On December 31, a report of three late-stage cases by Wijaya et al. reported significant clinical and radio-
logical improvement after a single dose of ivermectin.220
16
January 2021
On January 3, Lawrie et al. published a preprint of a rapid review and meta-analysis of seven ivermectin
trials, indicating a mortality relative risk RR 0.17 (0.18-0.35) and prophylaxis cases RR 0.12 (0.08-0.18).221,222
Also on January 3, Kaur et al. published a review including results of molecular dynamics simulations.223
On January 4, Lawrie submitted an initial report to the UK government, including results of RCT trial
and basic quality observational controlled trials, showing 83% reduction in mortality.224 On March 6, she
mentioned not getting any response from the government.
On January 4, Arab News published in Saudi Arabia with a target audience of businessmen, executives and
diplomats wrote about the meta-analysis by Hill et al., describing it as possibly transformative, with a cost
of USD 1-2 for a treatment course.225,226
On January 6, an uncontrolled retrospective study about ivermectin prophylaxis (0.2mg/kg weekly for eight
weeks, followed by 4 months rest) for healthcare workers in in Argentina by Hirsch and Carvallo reported
no infections among the 162 participants.227
On January 6, a randomized controlled clinical trial in Nigeria by Babalola et al. indicated a 58% lower risk
of no virological cure with 12 mg of ivermectin (n=40, p=0.01).228
On January 6, Marik and Kory from the FLCCC Alliance appeared before the NIH’s COVID-19 Treatment
Guidelines Panel to urge review of current data and an updated NIH guidance.229
On January 6, MedPage Today wrote about “maverick physicians spurning randomized trials”, reviewing
the views of the FLCCC and its critics, writing that “[FLCCC members] don’t see a need for more data
and argue it would be unethical to give placebo to patients given the established safety of ivermectin.
But that’s raising more than a few eyebrows among others in the field”.230 The article reviewed Marik’s
invention of the hydrocortisone, ascorbic acid and thiamine protocol for sepsis, the FLCCC’s early adoption
of corticosteroids and the resulting 75% reduction in mortality in comparison to average hospital mortality,
and the introduction of the FLCCC’s I-MASK+ ivermectin protocol in October 2020. The article then
continued on to “what the science says”, mentioning four RCTs and South American experiences about
prophylaxis, five RCTs about early treatment, and four RCTs for late treatment, plus “a host of observational
studies and case series”. The article notes that only one of the studies, a retrospective study, was done in
the US.
FLCCC’s Kory was quoted commenting that “if someone wants to discount those studies .. . and says they
want to do an RCT with placebo, that’s problematic for me . .. I could not have a patient admitted to my
care and give placebo knowing what I know about ivermectin .. . [FLCCC members] are firm believers in
evidence-based medicine. But we disagree with how most practice evidence-based medicine. We think they
are way too biased toward randomized controlled trials and completely dismiss evidence from anything but
RCTs. We think that’s harmful and loses a lot of valuable data”. In contrast, an US medical ethicist was
quoted saying that he “doesn’t believe clinicians should be lowering our standards of evidence because we’re
in a pandemic . .. this group should be advocating strongly for a large, generalizable randomized trial if
they believe so strongly in the efficacy of ivermectin .. . If in fact it is effective, the only way to convince
the clinical and scientific community and allow patients all over the world to benefit is to prove the case in
such a trial .. . with good data and safety monitoring, if the benefits are as overwhelming as they claim, the
trial could be stopped early on the basis of interim data and the treatment rapidly instituted”.
MedPage Today mentioned the meta-analysis by Hill et al. supporting the conclusions of the FLCCC,
said MedPage Today had been unable to confirm whether Hill had been contracted by the WHO, then
quoted an infectious diseases physician who called Hill et al’s overall evidence “very low grade”, adding that
“this whole thing feels like déjà vu of the first two months of the pandemic when we weren’t decided about
hydroxychloroquine . .. we don’t want to come around a year later saying it didn’t help and it may have hurt”.
The rest of the article surveyed whether the FLCCC might have financial connections to pharmaceutical
companies with an interest in ivermectin, the politicization of the issue in the US, whether the intention of
the FLCCC was to undermine vaccinations, and ended with a demand for “proper studies”.
On January 8, a social media post about an epidemiological analysis by data analyst Juan Chamie compared
the state of Chiapas, Mexico which had adopted ivermectin, to other states which had not adopted it,
indicating a stabilization of cumulative case count in Chiapas but increasing case counts in other states.231
17
On January 8, the Ministry of Health of Peru reinstated ivermectin-containing home-treatment kits after
retracting them in late 2020.232
On January 8, South African Health Products Regulatory Authority (SAHPRA) raided a hospital in search
of ivermectin, not finding any.233,234
On January 9, a preprint about a double blind randomized placebo-controlled trial (n=112) about ivermectin
for mild to moderate disease in India by Kirti et al. did not achieve a statistically significant result but
suggested a trend to benefits with regard to mortality, ventilation and ICU admission, for example a 79%
lower risk of ventilation (p=0.09) and 89% lower risk of death (p=0.12) (CTRI/2020/08/027225).235,236
On January 9, Lawrie posted an open video letter to Prime Minister of the United Kingdom Boris Johnson,
stating her company’s biggest clients are the National Health Service of the United Kingdom (NHS) and
the WHO, for whom the company produces industry-independent medical evidence synthesis to support
international clinical practice guidelines.237,238,239,240,241,242 Lawrie urged Johnson to look at the evidence of
ivermectin’s effectiveness, stating her analysis solidly substantiated the FLCCC’s recommendation to adopt
ivermectin globally and systematically for COVID-19.
On January 11, a preprint about an animal dosing study by Mousquet-Melou et al. suggested that ivermectin
maintenance doses should be based on lean body weight instead of the total body weight in obese subjects,
while the loading dose should be based on the total body weight.243
On January 11, a randomized controlled trial (Ivercar-Tuc) about ivermectin and iota-carrageenan prophy-
laxis of 234 healthcare workers in Tucumán, Argentina by Chahla et al. indicated 0% vs 8% severe cases
(p=0.003) and 3.4% vs 21.4% of all cases (p<0.001) (NCT04701710).244
On January 11, a Macedonian journal wrote the drug agency MALMED had confirmed ivermectin was going
to be available in pharmacies across the country in a few days.245
On January 11, a German magazine for pharmacists introduced the Monash University in vitro study,
FLCCC protocols and their meta-analysis, experiences of Peru, Brazil and Paraguay, the ICON study in the
US, the NIH hearing on January 6 with a mention of Hill et al’s meta-analysis, and listed 18 observational
or randomized controlled trials that were completed by December 2020.246
On January 12, a preprint about a randomized controlled trial (n=60) about late treatment (severe illness)
in Turkey by Okumuş et al. compared low dose hydroxychloroquine, azithromycin and favipiravir with
and without ivermectin, indicating 80% lower risk of no virological cure (12% vs 63%, p=0.02) on day 10
(NCT04646109).247
On January 12, a post on the FLCCC group’s Facebook page commented that a post by a group member
“had been taken down for using the full name of the the medicine—and then restored one day later upon
appeal” which was interpreted as Facebook “beginning to recognize the growing body of irrefutable scientific
medical evidence”.
On January 13, a review by Kory et al. (the FLCCC group) was provisionally accepted by Frontiers of
Pharmacology.248
On January 14, the US NIH updated its guideline on ivermectin, stating that there are insufficient data to
recommend either for or against the use of ivermectin.249 The NIH COVID-19 Treatment Guidelines Panel
Financial Disclosure for Companies Related to COVID-19 Treatment or Diagnostics (updated on February
11, 2021 but covering a period from October 1, 2019 to September 30, 2020, thus not indicating up-to-
date situation), indicated that the panel had 59 members, of which 35 (59%) reported no disclosures.250
Eight (14%) reported a connection to Merck & Co/MSD, of which one advisory board/consultant role, three
advisory board roles, two research support roles, one consultant/research support role and one honoraria
role. The updated guideline opened up the possibility of treating COVID-19 patients with ivermectin.
On January 15, the Association of American Physicians and Surgeons (AAPS) applauded the NIH guide-
line change.251 AAPS executive director Jane M. Orient referred to 49 ivermectin studies summarized on
c19study.com, 100 percent of which showing favorable results. Orient noted that many medical facilities and
many physicians refuse to prescribe it for COVID-19, citing NIH guidance, adding that “Perhaps with this
change, patients won’t need a court order to get a lifesaving drug . . . To have a doctor withdraw a drug that
appears to be saving a patient’s life, because a federal bureaucracy thinks it hasn’t been studied enough for
that use, is shocking to those who believe in the traditional ethic of Hippocrates”.
18
On January 15, a news report described a case in the US, in which family members of a 80-year ventilated
patient in a severe condition had asked the ICU doctors to administer her ivermectin.252 A doctor had
administered one dose, with the patient then taken off the ventilator and transferred out of the ICU in less
than 48 hours. Her condition had then deteriorated but the hospital had refused to administer further doses.
The family members had subsequently acquired a court order for the hospital to immediately administer the
patient more ivermectin, which the judge had agreed to.
On January 15, a newspaper reported that El Salvador had classified ivermectin as an over-the-counter
product to boost self-medication in order to combat a second wave of COVID-19.253 A television channel
in Honduras was said to have promoted ivermectin as a prophylaxis against COVID-19 “for months”. The
government of Honduras, Guatemala, El Salvador and others in South America were said to have begun
distributing home kits with vitamins, acetaminophen, antibiotics and ivermectin in mid-2020 for patients
with mild symptoms. By the end of 2020, 18,000 kits had been distributed in El Salvador. In Honduras,
packages with azithromycin, ivermectin and zinc were distributed. A Honduran scientist commented that
“developed countries make adequate studies to make decisions and our countries are based on anecdotal
information and, practically, anything they hear they set it in motion”. The government was accused of
overpaying and corruption after having purchased 6 mg tables for 1.08 dollars instead of 0.19 cents per
tablet.
On January 15, Bulgarian Drug Agency issued a marketing authorization for 3 mg ivermectin tablets by
prescription.254
On January 16, a preprint about a randomized controlled trial (n=103) in Pakistan by Asghar et al. indicated
a 90% viral clearance with 0.2mg/kg ivermectin vs 44% in controls (p<0.001) on day 7 (NCT04392713).255,256
On January 16, a preprint about a randomized controlled trial (n=100) about early treatment in Beirut,
Lebanon by Raad et al. indicated a 59% lower risk of viral load (p=0.01) at day 3 (ChiCTR2000033627).257
On January 16, a research letter by Bernigaud et al. described a case of oral ivermectin administration for
controlling a concomitant COVID-19 and ivermectin-treated scabies outbreak in a French long-term care
facility.258
On January 17, the FLCCC Alliance commented the updated NIH guideline, stating that it “considers the
Panel’s unwillingness to provide more specific guidance in support of the use of ivermectin in COVID-19 to
be severely out of alignment with the known clinical, epidemiological, and observational data”.259
On February 17, Africa CDC issued a statement on using ivermectin for COVID-19, citing “no scientific
evidence”, “no safety data”, limitations of the existing studies, that “the doses used in the in laboratory to
produce those results are 100-fold higher than those approved for use in humans”, concluding that “data
from well-designed, randomized, controlled clinical trials are needed to provide evidence for decision”.260
On January 18, a preprint asked whether a part of the mortality assigned to COVID-19 may be due to an
undiagnosed concomitant strongyloidiasis hyperinflammation.261
On January 19, a WHO-funded meta-analysis with 40 authors including Andrew Hill analyzed 18 random-
ized controlled trials with a total of 2,282 patients. The results indicated improved clinical recovery, and
lower hospitalization and mortality. Six RCTs of moderate or severe infection indicated a 75% reduction in
mortality (RR 0.25, CI 0.12-0.52, p=0.0002).262 The report stated that “this meta-analysis investigated iver-
mectin in 18 randomized clinical trials (2,282 patients) identified through systematic searches of PUBMED,
EMBASE, MedRxiv and trial registries. Ivermectin was associated with reduced inflammatory markers (C-
Reactive Protein, d-dimer and ferritin) and faster viral clearance by PCR. Viral clearance was treatment
dose- and duration-dependent. In six randomized trials of moderate or severe infection, there was a 75%
reduction in mortality (Relative Risk=0.25 [95% CI 0.12-0.52]; p=0.0002); 14/650 (2.1%) deaths on iver-
mectin; 57/597 (9.5%) deaths in controls) with favorable clinical recovery and reduced hospitalization. Many
studies included were not peer reviewed and meta-analyses are prone to confounding issues. Ivermectin
should be validated in larger, appropriately controlled randomized trials before the results are sufficient for
review by regulatory authorities.”
On January 19, a randomized controlled trial on hospitalized patients (n=103) in Iran by Rezai et al.
indicated a 21% lower recovery time (p=0.02) and 18% lower hospitalization time (p=0.01).263,262 On the
same day, Tehran Times wrote that Iran was starting its own production of ivermectin.264
On January 20, MedPage Today interviewed an US chief of hospital medicine who warned against parasitic
“hyperinfection” in foreign patients, saying they “will need to be treated prophylactically for strongyloides,
19
a parasitic infection that can emerge after corticosteroids are administered. The regimen is two doses of
ivermectin, one day apart, with the first dose preferably given before steroids are administered”.265
On January 20, a peer-reviewed in vitro study by Mody et al. indicated that ivermectin blocked more than
85% of 3CLpro activity of SARS-CoV-2, thus suggesting an additional antiviral mechanism via inhibitory
effects on 3CLpro, in addition to the previously identified blocking of α/β1 importin.266
On January 20, the Financial Times wrote that a cheap antiparasitic could cut chance of Covid-19 deaths
by up to 75%, citing the WHO-funded meta-analysis carried out by Hill et al.267 Hill stated that the drug
costs USD 3 in India and USD 960 in the US. Hill also noted that the purpose of his group’s meta-analysis
was “to forewarn people that this is coming: get prepared, get supplies, get ready to approve it . . . we need
to be ready”.
On January 21, a second, more polished preprint by Chamie-Quintero et al. analyzed the effects of distribu-
tion of ivermectin in Peru, spanning an area equivalent to that from Denmark to Italy and Greece in Europe
or from north to south along the US, with a total population of 33 million.268 In 24 Peruvian states vs one
state without distribution, excess deaths for ages >=60 dropped by 59% vs 25% at 30 days, and by 75% vs
25% at 45 days after the day of peak deaths, even though indices of community mobility rose over the same
period. For nine states that carried out mass distributions of IVM in a short timeframe through a national
program, excess deaths at 30 days dropped by a population-weighted mean of 74%, each drop beginning
within 11 days after the program start.
On January 23, the Times (UK) wrote that researchers at Oxford University are planning “the first, large
high-quality trial of a cheap drug that has been credited with dramatically reducing Covid-19 deaths in the
developing world”.269 The trial was named ‘Principle’, aimed at identifying an early treatment method that
would prevent severe illness.
On January 24, the FLCCC Alliance posted an open letter to the investigators of the Principle trial, urg-
ing the investigators to properly inform enrolling patients about the efficacy of ivermectin, stating that
“inadequately communicating this information to potential participants would be a violation of the pri-
mary responsibilities of clinical researchers as directed by the Belmont report to protect human subjects of
biomedical research”.270
On January 25, a third attempt to allow emergency use of ivermectin in France was addressed to the Council
of State. Among the plaintiffs were 18 doctors and three associations: Syndicat des Médecins d’Aix et Région,
International Association for Scientific, Independent and Benevolent Medicine, and Bon Sens.148,271
On January 25, Merck & Co/MSD announced that it discontinues development of COVID-19 vaccine can-
didates but continues development of two investigational therapeutic candidates, MK-4482 (molnupiravir)
and MK-7110.272 Molnupiravir was described as an oral novel antiviral agent for both in- and outpatients,
with initial efficacy data expected to be available in the first quarter of 2021.
On January 25, a news report described professor Cacopardo’s experiment in treating patients with severe
disease in Sicily, Italy a success, with Cacopardo commenting that “the patients who were given ivermectin
did very well .. . I have the impression that ivermectin combined with traditional therapies is able to effect
a dramatic improvement in clinical picture . .. we have used it in four serious cases of bilateral pneumonia
. .. after the administration of ivermectin, an impressive improvement of the clinical picture was observed
in the next 48 hours”.273 The medicine was said to cost 12 cents per dose to produce.
On January 26, a news report about the trial in Sofia, Bulgaria (EudraCT 2020-002091-12) said the double-
blinded, placebo-controlled ivermectin study had been conducted with 100 patients in 12 centers, with 0.4
mg/kg of ivermectin on three consecutive days.274,275,276 The results were said to be positive, with a mention
about reporting them to the WHO in order to include ivermectin in the COVID-19 treatment options.
On January 27, the CovidAnalysis group claimed that the retrospective database analysis of 5,683 patients
in Peru by Soto-Becerra exhibited “clear evidence of extreme bias”.118,121
On January 27, in a parliament session, an UK member of parliament David Davis asked Prime Minister
Boris Johnson about enhancing primary care to reduce the need for hospitalization, mentioning ivermectin
has been observed to reduce mortality by 75%. Johnson replied that he is aware of the results and that
therapeutics task-forces are currently reviewing ivermectin.277
On January 27, a preprint of a meta-analysis by Castañeda-Sabogal et al. including twelve studies (five
retrospective cohort studies, six RCTs and one case series) with a total of 7,412 participants stated that
20
all studies had a high risk of bias and showed a very low certainty of the evidence. Ivermectin was not
associated with reduced mortality (logRR 0.89, 95% CI 0.09-1.70, p=0.04, I2=84.7%), or reduced patient
recovery (logRR 5.52, 95% CI -24.36-35.4, p=0.51, I2=92.6%). The meta-analysis concluded that there was
insufficient certainty and quality of evidence to recommend the use of ivermectin to neither outpatients,
inpatients nor prophylaxis.278 The CovidAnalysis group described the meta-analysis as “student-written
meta analysis of a very small subset of studies exhibiting very high bias and significant flaws .. . [having] no
logic in the exclusion reasons . .. we checked the reported results for the mortality outcome and found they
do not appear to match the actual papers”.279
On January 27, a news report stated that the South African Health Products Regulatory Authority (SAH-
PRA) will consider ivermectin on a case-by-case basis, requiring practitioners to apply for approval before
use.280
On January 29, a final peer-reviewed version of an article by Jans and Wagstaff was published.9
On January 29, the French national institute of health and medical research (Institut national de la santé et
de la recherche médicale) issued a press release warning against the use of ivermectin outside clinical trials,
criticizing the first in vitro study and studies by Rajter et al. and Bernigaud et al.281,282
On January 30, Tokyo metropolitan government announced plans to conduct clinical trials for patients with
mild symptoms at hospitals. The plan was to eventually apply the method for outpatient treatment.283 The
article also mentioned that a 240-patient clinical ivermectin trial had begun at Kitasato University Hospital
in September 2020 for 240 patients.
Slovakia adopted ivermectin country-wide in January, with reports indicating limited availability and late
treatment only.3It had been used since early January by professor Pavol Török who later convinced the
Ministry of Health to adopt it.284
Country-wide adoptions of ivermectin happened in Guatemala on January 23, in Nicaragua on January 25,
in Lebanon on January 27, and in Zimbabwe on January 28.3,285
February 2021
On February 1, a news report was published by an UK and Australia based medical news site describing
itself as “one of the world’s leading open-access medical and life science hubs .. . with 374,000 members,
12,000 Twitter followers and 268,000 likes on Facebook . . . [and] a trusted source of all your medical and life
science needs”, compliant with a Switzerland-based Health on the Net Foundation’s HONCODE certificate
of compliance. The news report reviewed the meta-analysis by Castañeda-Sabogal et al., concluding that
there was no evidence that ivermectin changed the clinical outcome of inpatients or outpatients.286
On February 2, the Wall Street Journal published an opinion piece by US senate representative Ron Johnson,
stating that YouTube had censored Dr. Pierre Kory’s testimony to US Senate Committee in which he asked
the National Institutes of Health to review the current data on ivermectin.287
On February 2, a preprint about a randomized controlled trial about early ivermectin treatment in mild and
moderate COVID-19 (RIVET-COV) in India by Mohan et al. comparing 24 mg (n=40), 12 mg (n=40) and
placebo (n=45) did not indicate a statistically significant result.288
On February 3, Al Jazeera briefly covered India’s experiences of ivermectin, interviewed Wasif Ali Khan
from Bangladesh and Kory of the FLCCC, and mentioned Slovakia.289 On the same day, a news report from
Peru described some details of the conflicts in the country, saying attempts to talk about ivermectin “lead
to stoning . .. it’s like trying to discuss abortion with ultraconservatives”.290
On February 4, Ramírez et al. published a commentary in the Lancet, stating that “in the face of a virus
with a high mutation rate that could lead to loss of effectiveness of vaccines, worldwide research of therapies
for COVID-19 such as ivermectin should not be idled”.291
On February 4, Merck & Co/MSD gave a statement on the use of ivermectin on COVID19.292 They noted
that their analysis identified “no scientific basis for a potential therapeutic effect against COVID-19 from
pre-clinical studies; no meaningful evidence for clinical activity or clinical efficacy in patients with COVID-
19 disease, and; a concerning lack of safety data in the majority of studies”, concluding that they “do not
believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations
indicated in the regulatory agency-approved prescribing information”.
21
On February 4, a Belgian virologist Wathelet proposes a plan to eradicate SARS-CoV-2 in Belgium in six
weeks using ivermectin, calling for prophylaxis with two doses of 0.3 mg/kg 72 hours apart every month,
early treatment of outpatients, and treatment of hospitalized patients.293 The author of the news report
concludes that “a failure to act swiftly on [the existing research] evidence might begin to look like dereliction
of moral responsibility”.
On February 5, a Brazilian manufacturer of ivermectin issued a declaration, stating that in Brazil, ivermectin
has been an option for early treatment since the beginning of the pandemic but especially after publication of
the Monash University study.294 It mentioned that due to existing widespread use in other diseases and low
impact in terms of side effects, a large part of the medical community had adhered to treatment protocols
based on ivermectin, among other options. The statement mentioned proven safety due to previous use,
and dozens of international studies. It also stated that “the growth of market for ivermectin, a low-cost and
therapeutically low-risk product, naturally bothers especially companies that are interested in launching
high-cost patented products for the same disease, and this can motivate campaigns against it in the media”.
On February 5, a preprint of a randomized controlled trial of relatively low risk hospitalized patients (n=100)
by Bukhari et al. indicated a significantly lower risk of no virological cure (10% vs 56%, p<0.001) at day 7
(NCT04392713).295
On February 5, the FLCCC Alliance responded to YouTube’s removal of the video of Kory’s senate hearing,
stating that “YouTube unilaterally decided that [Kory] citing extensive scientific evidence, was giving ‘dan-
gerous and misleading’ information . .. while he was attempting to inform the government that there was a
safe, proven and inexpensive way to immediately begin to save lives, dramatically lower case counts and signi-
ficantly slow the pandemic itself .. . [it is] dangerous for social media giants like YouTube to indiscriminately
discredit and summarily remove official government information given under oath”.296
On February 7, the FLCCC Alliance published a response to Merck & Co/MSD’s statement, citing FLCCC’s
provisionally accepted review, the CovidAnalysis group’s meta-analysis and other published studies and
preprints on ivermectin’s efficacy and safety.297
On February 9, a new ‘Together’ trial led by McMaster University and partly funded by the Bill and Melinda
Gates Foundation was announced (NCT04727424).298,299,300,301 The ivermectin arm was apparently planned
to be carried out in Brazil, with a single dose of 18 mg for participants weighing 40-60 kg and 24 mg for
participants over 60 kg. The number of participants was expected to be up to 3,200, with results available
within three to six months. On the same day, the chairman of Tokyo Medical Association in Japan stated
that family doctors should administer ivermectin to infected outpatients.302,65
On February 10, a peer-reviewed report of a prospective trial of outpatients (n=768) by Lima-Morales
et al. indicated that 481 patients treated with ivermectin, azithromycin, montelukast and aspirin showed
significantly lower mortality (3% vs 18%, p<0.001) and hospitalization (9% vs 31%, p<0.001), and lower
risk of no recovery at 14 days (16% vs 41%, p<0.001) in comparison to 287 controls.303
On February 11, the NIH declined a Freedom of Information Act request about details on the process that
lead to its most recent ivermectin recommendation.304
On February 11, ivermectin had become available without prescription in Bulgaria, with people later queueing
to buy it at pharmacies across the country.305,306,307
On February 12, preliminary results of a double blind randomized controlled trial about early ivermectin
treatment of mild-moderate outpatients by Schwartz et al. in Israel indicated a significantly faster reduction
in viral load (NCT04429711).308,309
On February 15, a Japanese magazine noted that ivermectin was a Japanese invention by Satoshi ¯
Omura
and referred to a FLCCC Alliance report and promising studies from Egypt, Iraq, India and Bangladesh.310
On February 15, a preprint of a second, larger study on prophylactic role of ivermectin in SARS-CoV-2
infection among healthcare workers (n=3,532) by Behera et al. indicated a 83% lower risk of infection
(p<0.001) in 2,199 workers who had received a two-dose ivermectin prophylaxis.311
On February 16, a peer-reviewed version of Behera et al. study about ivermectin prophylaxis of healthcare
workers (n=117) indicated a 73% lower risk of in infection (p<0.001).142,143
On February 16, a peer-reviewed non-randomized controlled trial (n=113) on the effect of a combination of
nitazoxanide, ribavirin and ivermectin plus zinc supplement (MANS.NRIZ) on the clearance of mild COVID-
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19 by Elalfy et al. indicated a significantly faster viral clearance: 58% vs 0% on day seven, and 89% vs 7%
on day 15 (p<=0.001).312
On February 16, the Guardian wrote that a member of parliament of Australia had been banned from
Facebook for a week for posting three pieces of misinformation, one of which was claiming ivermectin’s
usefulness for COVID-19.313
On February 18, version 34 of the CovidAnalysis group’s meta-analysis covered 41 studies including 14,833
patients, 100% of which reported positive effects.314 20 of the studies were randomized controlled trials with
a total of 2,796 patients, indicating an estimated risk reduction of 72% (RR 0.28, CI 0.17-0.47, n=2,796,
p<0.000001). Of these, improvement in early treatment was 70% (RR 0.30, CI 0.17-0.51, n=611), in late
treatment 57% (RR 0.43, CI 0.25-0.72, n=1,447), and in prophylaxis 91% (RR 0.09, CI 0.06-0.15, n=738).
Six RCTs investigating mortality indicated a 75% reduction (RR 0.25, CI 0.12-0.52, n=1,258, p=0.00012).
Considering all 41 studies, prospective studies indicated a slightly larger improvement than retrospective
studies.
On February 20, Lawrie and a British company, Evidence-based Medicine Consultancy Limited (E-BMC
Ltd) organized a meeting under the name of British Ivermectin Recommendation Development (BIRD), a
recording of which was put available on YouTube.315 The recording was apparently censored from YouTube
but later reinstated there and advertised on Twitter. The meeting panel of 75 participants issued issued a
recommendation for immediate global use of ivermectin. The summary described desirable effects as large,
undesirable effects as trivial, the certainty of evidence as high, and indicated large savings of resources and
a favorable cost-effectiveness, acceptability and feasibility.
On February 20, a Czech Republic newspaper reported that the head of the department of anesthesiology
and intensive care at the Bratislava National Oncology Institute had administered ivermectin to her patients
for two weeks, since they became aware of the possibility.284 She stated its safety had been demonstrated
and when started early it appeared to eliminate the virus. The article also noted there had been resistance
towards its use in the country, however there had been a promising trial by Schwartz et al. in Israel, and
the Slovakian experience had been good. The article referred to a statement by the mayor of Bratislava, the
capital of Slovakia, stating that local real-life results suggest a benefit especially in the outpatient setting,
preventing deterioration and hospitalization. The mayor stressed the need to obtain ivermectin in large
quantities.
On February 22, the Brazilian manufacturer of ivermectin, Vitamedic, reportedly commented further on
Merck/MSD’s statement on February 4, saying Merck’s stance on effectiveness of ivermectin “reflects its
isolated opinion on the matter”, adding that “contrary to what Merck says, there is medical and scientific
evidence around the world demonstrating the antiviral action of the drug. Dozens of studies carried out in
several countries demonstrate the benefits of the drug, especially in the early stages of the disease and, for
this reason, the international medical community and also in Brazil started to include it in the treatment
protocols of COVID-19. It is a low-cost drug with low impact in terms of adverse effects”.316
.On February 23, a small study (n=106) by Beltran-Gonzalez et al. about hydroxychloroquine (n=33),
ivermectin (n=36) and placebo (n=37) did not produce statistically significant results (NCT04391127).317
On February 23, a report on TrialSite News accused Soto-Becerra et al. study about unreported protocol
violations causing it to show a negative result which was later quoted in the NIH recommendation and was
claimed to have negatively influenced it.120
On February 23, a hospital in the Czech Republic was reported to have tested ivermectin in 30 severe patients
with COVID-19 since November 2020, with all patients recovering. Doctors intended to continue ivermectin
treatments, commenting its affordability and the good results, despite comments by the director of the State
Institute for Drug Control saying studies were incomplete and the Prime Minister saying ivermectin was not
suitable or effective.318
On February 24, CovidAnalysis group wrote that WHO approved ivermectin for scabies after six studies
with a total of 613 patients indicating that ivermectin provided 35% improvement, yet WHO had not
approved ivermectin for COVID-19 after 21 randomized controlled trials with 2,869 patients indicating 70%
improvement and a total of 42 studies with 14,906 patients indicating 75% improvement.314
On February 25, UK newspapers reported ivermectin could cut deaths by 75%, referring to Paul E. Marik
and Pierre Kory of the FLCCC group, and to Lawrie’s and E-BMC Ltd’s 97-page report that was said to
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have been sent to the WHO.319,320 On the same day, the Medical Association of Jamaica requested adoption
of ivermectin.321
On February 25, the Scottish government responded to a January 14 information request about adoption of
ivermectin, stating it is aware of the ongoing trials, that prescribers should pay particular attention to the
risks associated with using a licensed medicine off-label, and that granting a license for use in COVID-19
would require an application for a marketing authorization be made to the Medicines and Healthcare products
Regulatory Agency (MHRA), which has not received such an application but would have processes in place
to expedite such an application, as required.322 It further explained that compassionate access authorization
for unlicensed medicines in individual extreme medical cases is initiated by the patient’s doctor “who will
have decided that the medicine is the best and the only available treatment option” but that “it is for
a pharmaceutical company to determine whether they will offer a medicine though a compassionate use
process . .. the decision to grant an individual patient compassionate access is one that the pharmaceutical
company makes”.
On February 25, a mayor in Slovakia denounced obedience to the government and provided ivermectin for
the inhabitants of his village, stating that “waiting for the government does not make sense. We start not
only with treatment, but also with prevention. All under the strict supervision of a doctor”.323 The article
reported that Ministry of Health had granted an exception for ivermectin and it was available at hospitals but
not yet available at pharmacies. The mayor said he was convinced it should be used also at outpatient clinics
for early intervention, and after weeks of searching he had been able to acquire 500 doses, to be delivered by
the local doctor. The mayor had discontinued COVID-19 testing in favor of ivermectin prophylaxis, saying
“testing is not a cure”.
On February 25, a South African civil rights organization claimed that due to a failure by the regulatory
authority SAHPRA to properly register ivermectin as a medicine, and due to unregistered medicines not
automatically being illegal, ivermectin for COVID-19 had been legal all along.324
On February 26, Syed and Kory discussed prevailing basic misunderstandings about COVID-19, such as it
still being characterized as viral pneumonia instead of organizing pneumonia, and varying clinical practices
with regard to timing of corticosteroid administration.325 Kory also described Aguirre-Chang’s “therapeutic
test” for post-COVID-19 syndrome, consisting of 0.2-0.3 mg/kg ivermectin twice daily for five days, with
aspirin 600 mg divided into 2-3 doses daily. If the patient responds to the treatment after five days, both
medicines were continued until symptoms had completely resolved. According to Aguirre-Chang, 75%-85%
of approximately 300 patients had responded.
On February 27, version 37 of the CovidAnalysis group’s meta-analysis added an analysis including only
peer-reviewed studies, of which there were 18.314 In these studies, improvement in early treatment was 84%
(RR 0.16, CI 0.06-0.44, n=268), in late treatment 39% (RR 0.61, CI 0.39-0.94, n=1,275), and in prophylaxis
92% (RR 0.08, CI 0.02-0.25, n=2,127). All in all the 18 studies indicated a 75% improvement (RR 0.25, CI
0.16-0.41, n=3,670, p<0.0001).
On February 28, a preprint by Bartoszko et al. presented a meta-analysis in which only three ivermectin
trials fulfilled the eligibility criteria (Shouman et al. (NCT04422561),99 Chahla et al. (NCT04701710),244 and
Elgazzar et al.155), concluding that there was a “very low certainty evidence” of the efficacy of ivermectin.326
On February 28, an Irish newspaper reported that critical patients would start receiving ivermectin as part
of an international REMAP-CAP clinical trial (NCT02735707).327,328 Some hospitals had reportedly already
begun using ivermectin off-label.
March 2021
On March 1, the abstract of the already peer-reviewed and provisionally accepted ivermectin review by Kory
et al. with over 86,000 views was removed from Frontiers of Pharmacology.248 A media statement published
the next day by the chief executive editor stated that the article made “a series of strong, unsupported claims
based on studies with insufficient statistical significance, and at times, without the use of control groups.
Further, the authors promoted their own specific ivermectin-based treatment which is inappropriate for a
review article and against our editorial policies . .. this paper does not offer an objective nor balanced
scientific contribution”.329 A news article noted that there was no explanation as to why such concerns were
not taken into account earlier in the process.330
24
On March 1, a preprint of an in-silico analysis predicted that ivermectin has a large binding affinity for the
SARS-CoV-2 spike protein.331
On March 2, a Canadian broadcast station posted a video interview of Ondrej Halgas at the University of
Toronto.332 The interview host referred to the unsatisfactory results of lockdowns and delays with vaccina-
tions. The interview reviewed the cost, availability and status of the research on ivermectin.
On March 3, ivermectin was provisionally authorized by the Ministry of Health of the Czech Republic.333
The decision cited FLCCC protocols and the CovidAnalysis group’s meta-analysis.334 A Czech Republic
newspaper reported the head of a university hospital in Brno saying a large scale distribution to hospitals
and outpatients was beginning, with an initial inventory of 20,000 packages.335 The prime minister was
quoted saying that “we cannot wait for results of clinical trials, let’s just try this”.336 On the same day, a
German MD criticized German health politicians for ignoring ivermectin, demanding that every possibility
for the pharmaceutical industry to influence political decisions to be abolished.337
On March 3, a double-blind randomized trial to assess the safety and efficacy of ivermectin in asymptomatic
and mild severity COVID-19 patients started in Budapest, Hungary (EudraCT 2021-000166-15).338
On March 3, Yang et al. published an article showing that ivermectin’s broad spectrum antiviral activity
relates to its ability to target the host importin (IMP) α/β1 nuclear transport proteins responsible for nuclear
entry of cargoes, and that ivermectin can limit infection by the West Nile virus at low (μM) concentrations.339
On March 3, Syed discussed whether ivermectin interferes with efficacy of the vaccines, concluding that
it does not.340 On the same day, an US clinic announced they are offering telemedicine-based early out-
patient treatment for patients with active infection and for patients experiencing post-COVID long-hauler
symptoms.341
On March 4, a randomized clinical trial of low risk patients (n=398) in Colombia by López-Medina et al.
did not reach statistical significance (NCT04405843).342 The CovidAnalysis group claimed that endpoints
had been changed mid-study, the authors had received grants and personal fees from five pharmaceutical
companies including Merck/MSD also during the study period, a large part of the control group was excluded
due to receiving ivermectin, and it was suspected that even more controls had received ivermectin instead
of placebo.343,224
On March 4, the New York Times wrote that “a controversial anti-parasitic drug that has been touted as
a potential Covid-19 treatment, does not speed recovery in people with mild cases of the disease, according
to a randomized controlled trial published on Thursday in the journal JAMA . .. scientific evidence for its
efficacy against the coronavirus is thin .. . the trial was relatively small and did not answer the most pressing
clinical question, whether ivermectin can prevent severe disease or death . . . bigger trials, which are currently
underway, could provide more definitive answers .. . there’s such chaos in the field”.344
On March 4, MedPage Today wrote about “a Colombian trial flop”, mentioning a change of the primary
outcome and a labeling error resulting in all patients receiving ivermectin for two weeks, these patients being
excluded from the primary analysis and additional patients being recruited", adding that the authors had
described the study as possibly underpowered.345
On March 4, the Kory et al. preprint previously provisionally accepted to Frontiers of Pharmacology was
posted at ResearchGate with explanations stating that the the manuscript had passed through three rounds
of peer-review by four different peer reviewers, two of them being career FDA scientists.346 After these reviews
it was accepted for publication on January 13. After a long delay without online publication of the full paper,
the abstract was suddenly taken down on March 1, with the authors receiving a rejection letter based on
an anonymous external reviewer’s opinion that conflicted with the previous four peer reviewers and found
the manuscript to contain “unsupported conclusions”. The authors noted that the rejection occurred despite
the journal’s documented knowledge of identical conclusions by the 75-member international consortium on
February 20, the British Ivermectin Recommendation Guideline (BIRD) panel.
On March 4, a news article reported Portuguese MDs using ivermectin prophylaxis for themselves for a cost
of EUR 5 per month, and one doctor using it to contain an outbreak at a senior home with 63 residents.347
The ivermectin was produced by a Portuguese pharmaceutical company.
On March 4, Syed discussed whether ivermectin can fight all SARS-CoV-2 variants.348 According to him,
the only area in which ivermectin’s efficacy may be compromised is in preventing the spike protein binding
to receptors. Ivermectin binds to the spike protein, and if the spike protein changes significantly, ivermec-
tin might not bind to it. However, this has not happened. The second phase is viral fusion with the cell
25
membrane and release of RNA. Ivermectin does not have a function in this phase. The third phase is viral
replication. Ivermectin affects RNA-dependent RNA polymerase (RdRp) and 3CLpro which are common for
all variants.349,137,266 Fourth phase is cellular defense reduction, during which the virus enters the nucleus
through the host importin (IMP) α/β1 nuclear transport proteins.339 Ivermectin disrupts this process com-
mon for all variants. Another function of ivermectin is NF-kB (nuclear factor kappa-light-chain-enhancer
of activated B cells) blocking to prevent inflammation.4This is also common for all variants. In summary,
ivermectin is effective against all variants in preventing replication, entrance of viral cargo to cell nucleus,
and inflammation, but in theory, efficacy against binding may vary.
On March 5, FDA issued a consumer update warning against use of ivermectin to treat or prevent COVID-19,
yet simultaneously stated that it had not reviewed data to support use of ivermectin in COVID-19.350
On March 5, German medical magazine wrote about the Colombian trial, starting from the Caly et al. in
vitro study, moving on to the Surgisphere scandal, and finally the Colombian trial, ending by mentioning
that the authors of the trial “assumed that the treatment will probably not be of any (great) benefit”.351
Readers’ comments referring to the meta-analysis by Lawrie et al. objected with the conclusion.
On March 5, MedinCell published a preprint of an expert review on the safety of ivermectin by Descotes who
held shares to MedinCell but had no other relevant affiliations or financial involvement.352,353,354 MedinCell
noted the review will be submitted for peer review to an acknowledged journal. The report stated that “it
is of note that neither deaths nor severe adverse events attributable to ivermectin have been reported . ..
the safety profile of ivermectin has so far been excellent in the majority of treated human patients so that
ivermectin human toxicity cannot be claimed to be a serious cause for concern”.
On March 6, according to a news report, professor Cacopardo in Sicily, Italy had successfully healed all of his
13 ivermectin-treated patients in just 3-5 days.355 Also, a Milan pharmacy announced it had begun shipping
ivermectin throughout Italy.
On March 6, a news article described outpatient treatment practices in Uttarakhand, India, consisting of a
home-delivered kit with a thermometer, an oximeter, azithromycin, paracetamol, three tablets of ivermectin,
vitamin C, ten masks, a bag for biohazardous waste and precise instructions, follow-up calls by a doctor
every two days, an in-person visit by two doctors on day 9 to check for a need of medication or oxygen, and
a test on day 14, all free of charge.356
On March 6, Lawrie stated that a two-week randomized controlled trial for the post-COVID-19 syndrome
(“long Covid”) would be appropriate and interesting.357 She mentioned the production cost of ivermectin
was USD 168 per kilogram, with a WHO document on treatment of scabies mentioning 100 tablets of 12 mg
each being available for a total cost of USD 2.90, thus indicating that the cost of a single treatment with
12-24 mg would be USD 0.03-0.06.358
On March 6, Merck & Co/MSD announced positive results of a 182-patient phase 2a RCT with MK-4482
(molnupiravir).359,360,361
On March 7, the FLCCC group issued a statement calling the FDA statement misleading, saying the guid-
ance may lead to avoidance of off-label prescribing and that the patients cannot wait for phase III trial
results.362 On March 7, in a CBS News interview, the director of the NIH mentioned a need for an oral broad-
spectrum medication for early treatment to be given immediately after a positive test result, that would also
be effective against viral variants. The director added that the NIH is working “right now” on producing
evidence on repurposed medicines including “colcichine, fluvoxamine and potentially ivermectin”.363,364 The
text of the story, however, only mentioned fluvoxamine. The director also mentioned that the hydroxychloro-
quine controversy had had “a detrimental impact on looking for existing drugs . .. maybe it got in the way
of trying other kinds of repurposed drugs . .. we had to get over that. I think we’re over it now”.
On March 8, a preprint by Chamie-Quintero et al. suggested that mass treatments with ivermectin most
likely caused a 14-fold reduction in excess deaths in Peru, and a later reversal of ivermectin policy caused a
13-fold increase.365,366 The preprint was reviewed by TrialSite News on March 3.
On March 8, an article in MedPage Today criticized Facebook third-party fact-checkers in a case of an
op-ed about epidemiology, stating that the fact-checkers appeared to be “disproportionately academics on
Twitter who have mega-follower counts. They mostly have similar worldviews, and advertise those views
on Twitter. In a different case, a reviewer already tweeted criticism of the article before being selected as
a ‘fact-checker’ . .. it is cherry picking criticism from Twitter celebrities in order to extinguish dissenting
26
opinions . .. it feels like a high school clique .. . it is antithetical to the spirit of the academy .. . this
process is not acceptable or fair”.367
On March 9, a preprint by Scheim et al. accused the recent trial by López-Medina et al. (NCT04405843)
of several protocol violations, including a labeling error substituting ivermectin for placebo doses of 38
patients, in addition to a blinding failure and patients in the control group possibly self-medicating with
over-the-counter ivermectin.342,368
On March 9, a peer-reviewed report of a small late treatment trial with 32 patients by Pott-Junior et al. did
not produce statistically significant results (NCT04431466).369
On March 9, referring to FDA consumer update on March 5, a MedPage Today article titled “FDA pooh-
poohs ivermectin” mentioned that “FDA detailed a laundry list of reasons on why not to use ivermectin for
COVID-19, including that it’s ‘not an anti-viral’ and that overdose could cause ‘seizures, coma and even
death’ ”.370
On March 10, a commentary by Kory stated that “doctors fighting COVID-19 should be supported by
their profession and their government, not suppressed. Yet today physicians are smothered under a wave of
censorship . .. many in positions of authority [are] stubbornly refusing to allow any repurposed treatments.
This departure from traditional medical practice risks catastrophe . .. when doctors on the front lines try
to bring awareness of and use such medicines, they get silenced . .. actually ‘following the science’ means
listening to practitioners and considering the entirety and diversity of clinical studies”.371
On March 11, a preprint by Bryant et al. (with Lawrie) presented a systematic review and meta-analysis
done using rigorous Cochrane methods.372 The review included 21 RCTs with 2,741 patients. Meta-analysis
of 13 trials indicated 68% reduction in mortality (RR 0.32, 95% CI 0.14-0.72, n=1,892, low to moderate-
certainty evidence). Low-certainty evidence found ivermectin prophylaxis reduced infections by 86% (95% CI
79-91). Low-certainty evidence also indicated reduction in deterioration to severe disease, and ‘improvement’
measured with various indicators, but no reduction in need for mechanical ventilation. As implications of all
the available evidence the authors stated that the apparent safety and low cost suggested that “ivermectin
could have an impact on the SARS-CoV-2 pandemic globally. Ivermectin is not a new and experimental
drug with safety concerns; it is a WHO ‘essential medicine’ usually used in different indications. It may be
useful for more health professionals to get access to this medicine for use against covid-19 during the ongoing
pandemic”.
On March 11, the discoverer of ivermectin Satoshi ¯
Omura stated that ivermectin should be used for COVID-
19 immediately without requiring any specific approval.373,374 According to ¯
Omura, ivermectin suppresses
both replication of the virus and the inflammation, in addition to activating the immune system.
On March 12, a preprint about an early treatment retrospective database analysis by Roy et al. with 56 pa-
tients with mild disease, all treated with zinc and vitamins C and D, compared placebo, ivermectin plus doxy-
cycline, azithromycin, and hydroxychloroquine, without finding statistically significant differences.375,376
On March 12, the CovidAnalysis group presented a comparison of the mortality results across the five existing
meta-analyses, with Kory et al. indicating 72% reduction (RR 0.28, 95% CI 0.19-0.45), Hill et al. indicating
75% reduction (RR 0.25, 95% CI 0.12-0.52), Bryant et al. indicating 68% reduction (RR 0.32, 95% CI 0.14-
0.72), Lawrie et al. indicating 83% reduction (RR 0.17, 95% CI 0.08-0.35), and the CovidAnalysis group’s
analysis indicating 75% reduction (RR 0.25, 95% CI 0.15-0.44).
On March 12, an editorial by Nardelli et al. presented a yet another meta-analysis of randomized clinical
trials on the impact of ivermectin on mortality.377 The meta-analysis utilized Mantel-Haenszel test and a
fixed-effects model, and included 1,323 hospitalized patients in seven RCTs performed in six countries. The
included studies were the early treatment trial by Ahmed et al. in Bangladesh and the late treatment trials by
Elgazzar et al. in Egypt, Hashim et al. in Iraq, Mahmud et al. in Bangladesh, Niaee et al. in Iran, Okumus
et al. in Turkey, and Kirti et al. in India.184,155,135,170,247,235,122 Mortality in patients treated with 12-24
mg ivermectin for 1-5 days was 2% vs 9% in the controls (OR 0.19, 95% CI 0.10-0.34, p<0.01). The authors
wrote that “ivermectin followed the opposite pathway of hydroxychloroquine: use of hydroxychloroquine was
supported at first by medical agencies worldwide, and later proven ineffective by several RCTs including
the RECOVERY Trial. On the contrary, ivermectin was mostly neglected so far and only used in a few
countries; nevertheless, scientific community is progressively building a body of randomized evidence which
points in favor of its use. After the ruinous experience during the first wave, however, physicians became
more ‘skeptical’ and less prone to use repurposed drugs in COVID-19 patients. Having cried wolf for too
long may be preventing the spread of ivermectin use all over the world. While modern medicine cannot
27
do without ironclad evidence, in an emergency situation the use of a cheap medication without major side
effects may be reasonable even if strong verification of its efficacy is still lacking. While there is an urge
of large high quality RCTs, results from the reported trials all point in the same direction, and cannot be
overlooked”.
On March 15, in a TrialSite News interview, Lawrie said that in the meta-analysis by Hill et al. she had
noticed a mismatch between the analysis and the conclusion. When she had contacted Hill asking him to
explain the mismatch, Hill had, according to Lawrie, replied that the conclusion of the meta-analysis had
not been his own: it had been changed by the sponsor of the study Unitaid.378,262 Lawrie also explained
difficulties in her attempts to get her group’s meta-analysis published by the Cochrane or journals. TrialSite
News commented that “there doesn’t seem to be any urgency here” with regard to adoption of treatments.
On March 16, the FLCCC announced on its Twitter account that their article rejected by Frontiers of
Pharmacology had been accepted by American Journal of Therapeutics.379
On March 16, an online television channel Reform TV in the United Kingdom, launched by a prominent
Eurosceptic Nigel Farage’s Reform UK, stated it had been exactly a year since the enactment of “the most
draconian legislation” that had “decimated peoples’ lives”, asking whether this progression could have been
prevented.380,381 Reform UK Deputy Leader, MD David Bull compared ivermectin to penicillin and aspirin,
explaining recent research and data from Peru by Chamie-Quintero et al. suggesting a decrease in excess
deaths after mass distribution and increase in excess deaths after restriction of distribution by the new pres-
ident in December 2020,365 with the interviewer describing it as ‘an extraordinary coincidence’, asking why
there had been very little discussion about ivermectin in the UK. Journalist David Rose described interna-
tional experiences (e.g. India, French care homes) and two “striking” meta-analyses by British scientists Hill
and Lawrie. Commenting on Merck & Co/MSD’s negative view of ivermectin Rose referred to economic
incentives related to Merck’s new drug in development, adding that with regard to ivermectin, “the Big
Pharma is going to have to take a back seat on this one”. Lawrie mentioned 14 RCTs consistently showing
benefits in prophylaxis and treatment. She added she believed the government had been informed about iver-
mectin by their foreign colleagues in 2020, but “for some reason it has not been prioritized . .. the developed
countries seem to be very highly influenced by the pharmaceutical industry”, with most studies conducted in
low-to-middle income countries familiar with ivermectin. She suspected more interest in smaller European
countries was due to being “last in line for vaccines” or unable to afford them. She mentioned developing
countries relying not only on RCTs but also on case studies and clinical experience accumulated since May
2020. Lawrie said it was already unethical to randomize people to a placebo group in an ivermectin trial,
but that there were no obstacles to an immediate rollout of ivermectin without further studies. According
to her, an earlier rollout would have saved hundreds, potentially thousands of lives of UK citizens.
On March 16, Orient wrote that the US pandemic response has failed at every level, likely causing 100,000
or more preventable US deaths. Orient concluded that “the disastrous global response to COVID-19 has
been plagued by lack of preparedness, conflicts of interest, highly politicized ‘science’, suppression of open
discussion, disregard of the bedrock principle of informed consent, and willful neglect of what is likely the
most important pillar of response: early treatment. Risk/benefit assessment is fatally compromised by
inaccurate, distorted, or absent data concerning the incidence and mortality of disease and the safety and
efficacy of countermeasures”.382,383
On March 17, a systematic review and and an individual patient data meta-analysis of ivermectin use in
children weighing less than 15 kg by Jittamala et al. concluded that existing limited data between January
1980 and October 2019 suggest that oral ivermectin in children weighing less than 15 kilograms is safe.14,384
Overall a total of 1.4% (15/1,088) of children experienced 18 adverse events all of which were mild and
self-limiting. No serious adverse events were reported.
On March 17, an interview of a Brazilian MD Adler Menezes described an ivermectin prophylaxis experiment
in a factory with 12,000 employees.385 Ivermectin was administered weekly to workers of one of two work
shifts, with infections disappearing in the prophylaxis group. Ivermectin was then administered also to
workers in the other shift, with the same result.
On March 18, the Infectious Diseases Society of America (IDSA), citing very low certainty of evidence, gave
a conditional recommendation against the use of ivermectin in hospitalized patients with severe COVID-19
and in outpatients with COVID-19, outside of the context of a clinical trial, adding that “adding that well-
designed, adequately powered, and well-executed clinical trials are needed to inform decisions on treating
COVID-19 with ivermectin”.386
28
On March 18, a Yale professor Santin, referring to Kory and CovidAnalysis group, stated he initially
did not believe such efficacy was possible but witnessed firsthand very rapid responses in both post-
COVID-19 syndrome patients with months of breathing issues, and in extremely severe patients close to
intubation.387,388,389
On March 18, Haroldo et al. published a retrospective follow-up of 856 patients.390
On March 19, a French magazine wrote about the French care home experience, the Hill et al. meta-analysis
and several other developments, and interviewed a French ivermectin proponent Maudrux who stated “we
are witnessing a drift in the analysis of scientific studies: we look at the methodology but we do not look at
the result”.391,392
On March 19, a news report claimed that the participants of the study by López-Medina et al. had not been
informed that they were receiving ivermectin and that they had only been informed that they were receiving
“D11AX22 molecule”.393
On March 21, The Manila Times in Indonesia wrote about the ivermectin controversy.394
On March 22, the CovidAnalysis group’s listing of all studies about ivermectin on COVID-19 included 72
studies, of which 35 were peer-reviewed and 46 with results comparing treatment and control groups.395
A March 17, 2021 version 47 of their meta-analysis of the 46 studies included eight randomized controlled
trials (of which six double-blind RCTs, one single-blind RCT, and one open-label RCT) on COVID-19
mortality in early treatment (two RCTs) or late treatment (six RCTs) indicated a 69% lower risk of death
(RR 0.31, 95% CI 0.16-0.61, p=0.00032, n=1,729).396
24 randomized controlled trials (of which 12 double-blind RCTs, two single-blind RCTs, and 10 open-label
RCTs) with 3,414 patients indicated a 70% improvement on the various measured indicators including death,
viral clearance, hospitalization, ICU admission, recovery, resolution of symptoms and infection (RR 0.30, 95%
CI 0.19-0.47, p<0.0001, n=3,414). Improvement in early treatment was 71% (RR 0.29, 95% CI 0.17-0.50,
n=1,125), in late treatment 55% (RR 0.45, CI 0.28-0.72, n=1,551), and in prophylaxis 91% (RR 0.09, CI
0.06-0.15, n=738).
21 peer reviewed trials (of which 11 observational trials, five double-blind RCTs, and five open-label RCTs)
with 4,215 patients indicated a 75% improvement on the same indicators (RR 0.25, 95% CI 0.16-0.40,
p<0.0001, n=4,215). Improvement in early treatment was 83% (RR 0.17, 95% CI 0.07-0.40, n=782), in late
treatment 41% (RR 0.59, CI 0.38-0.90, n=1,306), and in prophylaxis 92% (RR 0.08, CI 0.02-0.25, n=2,127).
The probability that an ineffective treatment generated results as positive as the 46 studies was estimated
to be one in 70 trillion (p=0.000000000000014). A remarkable feature was the unusual consistency of the
results, with all studies indicating positive effects, regardless of the phase of the disease.
As mentioned above, Bryant et al. had reviewed 21 RCTs with 2,741 patients, of which a selection of thirteen
RCTs in the Cochrane-standard meta-analysis had indicated 68% reduction in mortality (RR 0.32, 95% CI
0.14-0.72, n=1,892, low to moderate-certainty evidence).372
On March 22, “after reviewing the latest evidence”, the European Medicine Agency (EMA) advised against
use of ivermectin for the prevention or treatment of COVID-19 outside randomized clinical trials.397 EMA
stated that ivermectin medicines were not authorized for use in COVID-19 in the EU, and EMA had not
received any application for such use, however it noted that the Czech Republic and Slovakia had allowed
temporary use within the remit of their national legislation. EMA stated that “although ivermectin is
generally well tolerated at doses authorized for other indications, side effects could increase with the much
higher doses that would be needed to obtain concentrations of ivermectin in the lungs that are effective
against the virus. Toxicity when ivermectin is used at higher than approved doses therefore cannot be
excluded”. EMA added that “further well-designed, randomized studies are needed to draw conclusions”.
On March 24, a review by Yagisawa et al., a group including the discoverer of ivermectin Satoshi ¯
Omura,
was published in the Japanese Journal of Antibiotics.398
29
Discussion
A central question in the communications was whether more studies were needed. In November 2020, when
the FLCCC Alliance recommendation on ivermectin was formed, the decision to recommend it was assumedly
largely based on the perceived consistent positivity of the effects: “seeing a ‘signal’ in the data”. This method
could also be called reliance on “clinical experience” or even “intuition”.
Comparing five CovidAnalysis group’s meta-analyses from October 26 (n=21), December 29 (n=28), January
26 (n=35), February 27 (n=42), and March 17 (n=46),399 calculated improvements in clinical indicators,
with probabilities of an equal or greater percentage of positive results from an ineffective treatment, were as
follows: improvements in prophylaxis (pre-exposure/post-exposure or total) were 98%/87% (p=0.063/0.25),
91%/90% (p=0.0078/0.25), 90% (p=0.00098), 89% (p=0.00049), and 89% (p=0.00049), respectively. In early
treatment, the improvements were 91% (p=0.13), 87% (p=0.016), 84% (p=0.00098), 83% (p=0.00012), and
79% (p=0.000015). In late treatment, the improvements were 60% (p=0.00024), 48% (p=0.00012), 39%
(p=0.000031), 51% (p=0.0000038), and 52% (p=0.0000019). All together, the improvements were 75%
(p=0.00000048), 78% (p=0.0000000037), 74% (p=0.000000000029), 75% (p=0.00000000000023), and 72%
(p=0.000000000000014). It appears that in 2021 the variation in estimated efficacy due to addition of more
studies to the meta-analysis was too small to be clinically meaningful. Therefore, more studies provided
little additional clinically relevant information, and the argument against the treatment was solely based on
the assumed unreliability of all the existing data.
One of the main obstacles for reception of the idea of repurposed medicines may have been the Surgisphere
scandal and the widespread controversy regarding hydroxychloroquine in early 2020, leading to a generalized
distrust of research among the politicians, governmental administrative personnel and the public, especially
in the more developed countries which appeared to put more importance on the research. This distrust, in
turn, possibly opened new avenues for various kinds of societal manipulation.
The distrust appreared to have also lead to, for example, social media and video streaming platforms actively
but inconsistently and indiscriminately censoring many subjects and groups, including ivermectin research
groups and their results, regardless of their level of academic merit. These practices often appeared similar
to censorship practices in authoritarian countries. Mainstream media appeared to maintain an inverted
understanding on the process of science in which scientific knowledge was apparently assumed to flow down
from the NIH and WHO to the researchers, not the other way around. Financial newspapers (Wall Street
Journal, Financial Times) may have possessed a more realistic view on medical research and ivermectin than
generalist press conventionally considered high quality (e.g. The New York Times, Associated Press, The
Guardian), with some practically accusing researchers of not adhering to the guidelines given by the NIH, for
example. The open encyclopedia Wikipedia took pains to only mention negative studies about ivermectin,
listing it among the COVID-19 misinformation, even citing a commentator saying that “the narrative of
ivermectin as a ‘miracle cure’ for COVID-19 is a ‘metastasized’ version of a similar conspiracy theory around
the drug hydroxychloroquine, in which unspecified powers are thought to be suppressing news of the drug’s
effectiveness for their own malign purposes”.400,401,402
As noted by Wall Street Journal quite early on in the ivermectin saga, the majority of the medical estab-
lishment appeared to require almost absolute certainty, resulting in “too much caution killing patients”, both
health-wise and financially.172 This approach seemed to only take into account quite theoretical health risks,
disregarding not only the very probable societal harms of not taking any action but also the possible health
benefits of taking an action under uncertainty. Thus, the process appeared largely a failure of a relatively
simple risk-benefit analysis.
The more medically oriented arguments against the adoption of ivermectin were usually based on the hypoth-
esis that the required (as indicated by the Caly et al. in vitro study19 ) plasma and lung tissue concentrations
for an antiviral effect would likely not be achievable. Another argument was based on the host-directedness
and the assumed toxicity of larger doses.
During the period there appeared to be somewhat scarce interest in treatments research, with the wealthy
societies’ focus on vaccinations and lockdowns, despite vaccinations being largely unavailable and lockdowns
harmful for the economy. These countries appeared to pursue expensive, narrow-spectrum vaccination and
new pharmaceuticals based strategies, ignoring cheaper options, whereas developing countries put more em-
phasis on affordable, broad-spectrum antivirals. One factor may have been the developing nations’ clinicians’
familiarity with ivermectin and its easy availability, whereas it has been a rarely prescribed medicine in most
industrialized countries. In addition, prejudices and a bias against ideas originating outside of familiar or-
30
ganizations or one’s own country may have played a part in the industrialized countries ignoring ivermectin
research carried out in the developing countries.403
Cost-effectiveness of government funding for development of new medications and vaccines is an important
issue. The US government invested USD 356 million in 60,000-100,000 doses of MK-7110, indicating a unit
price between USD 5,933.00 and USD 3,560.00, with the initial results of efficacy indicating the same or
slightly smaller efficacy as that of ivermectin. A 2015 article about mass treatment of onchocerciasis in
Africa stated that Merck & Co/MSD had offered ivermectin at USD 1.51 per treatment, indicating a 2300
to 3900-fold difference between the prices of ivermectin and MK-7110.404,210 In this example, allocation of
US government funding appeared inefficient with respect to investment in an experimental product with
the unit costs in thousands of dollars, versus the option to use an existing medication with similar efficacy
proven at least on a similar level of evidence and the unit costs in single digits.
There was a widespread disagreement on the fundamentals: which methods were appropriate as a basis for
decision making, what counted as evidence, and what was ethical. In a broader view, the appropriateness
and usefulness of the evidence based medicine paradigm as it was understood and applied during the period
appeared questionable. US and European governmental bodies appeared to reject or ignore most of the
ivermectin-related data, referring to insufficient evidence. In the US, the paradigm appeared inconsistently
applied; more specifically, not applied to US Food and Drug Administration Emergency Use Authorization
of remdesivir, whereas strictly applied to other medications including ivermectin. In addition, a strict
requirement to compare a significantly more effective treatment to placebo may be considered unethical with
regard to high mortality of patients in control groups. These indicate a clear need for a new methodology
better than the current understanding and application of evidence-based medicine.
With regard to conflicts of interest, the US Food and Drug Administration (FDA) issued an Emergency Use
Authorization (EUA) for the use of remdesivir in patients with severe disease on May 1, even before the
initial results of an ongoing trial were published and despite remdesivir being an investigational drug not
approved for any indication. The 1,063-patient randomized controlled trial of remdesivir published on May
22 only indicated that remdesivir shortened the time to recovery (11 days vs 15 days, p<0.001).405 There
wasn’t an obvious difference in mortality rates (8% vs. 11.6%, p=0.059) and the endpoints were changed
mid-study which was deemed a questionable practice.406 The final results were published on October 8. On
August 28 the EUA was extended to “no longer require a severe disease”.
The adoption of corticosteroids as a consequence of the WHO-initiated 2,000-patient RECOVERY trial
results was relatively swift. Also the emergency use authorization of remdesivir in the US was swift, based
on initial and conflicting evidence. Twenty randomized clinical trial results on ivermectin’s efficacy for
COVID-19 were available in February 2021. These trials were predominantly carried out outside the US and
the EU, and did not lead to emergency use authorizations in the US or the EU.
US FDA document “Emergency Use Authorization of Medical Products and Related Authorities – Guidance
for Industry and Other Stakeholders” section “1. Criteria for Issuance” subsection “d. No Alternatives” states
that “For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the
candidate product for diagnosing, preventing, or treating the disease or condition. A potential alternative
product may be considered ‘unavailable’ if there are insufficient supplies of the approved alternative to fully
meet the emergency need. A potential alternative product may be considered ‘inadequate’ if, for example,
there are contraindicating data for special circumstances or populations (e.g., children, immunocompromised
individuals, or individuals with a drug allergy), if a dosage form of an approved product is inappropriate for
use in a special population (e.g., a tablet for individuals who cannot swallow pills), or if the agent is or may
be resistant to approved and available alternative products”.407
It may thus be derived that licensing of repurposed medicines such as ivermectin for outpatient treatment
and prophylaxis of COVID-19 would have prevented emergency use authorizations of new pharmaceuticals
in development. In the case of prophylaxis, such licensing might even have affected vaccines. Thus, there
appeared to exist substantial financial conflicts of interest against licensing of repurposed medicines.
Considering the total net utility of a society it is unlikely that unilateral support to only the investments of
the pharmaceutical industry could ever offset the harms to other industries and the population. The society
thus has a strong incentive to abolish the financial incentive structures of the pharmaceutical industry and
the government that led to the current situation, in order to prevent a similar outcome in the future.
Considering the estimated efficacy of ivermectin around 90% in prophylaxis and the option of an early
outpatient treatment with an estimated efficacy around 80%, an early introduction of ivermectin might have
31
prevented a large part of COVID-19 infections post first wave in many European Union countries and in the
United States.
Administrative issues, inconsistent requirements of evidence related to the evidence-based medicine
paradigm, and possibly conflicts of interest with patentable, commercial products in development prevented
introduction of early outpatient ivermectin treatments in the last quarter of 2020 and the first quarter of
2021. This lack of response is likely to have caused unnecessary deaths and difficult-to-repair financial and
health consequences in the affected societies.
The culture of medical litigation prevalent in the United States may have created patterns of behavior that
have also spread to countries with less actual litigation, yet leading to mental paradigms favoring extreme
caution and non-action, in turn leading to stagnation. One of the features of a paradigm is an inability of
the involved people to transcend it or even see that it is just one possible paradigm out of many options,
some of which may be more optimal in a given situation.
Conclusion
The period appeared conflicted, with researchers, clinicians, governmental agencies and commercial entities
holding deeply conflicting views on fundamental issues, including which methods were considered appropriate
as a basis for decision making, what could be considered as sufficient evidence, and what was ethical. In a
broader historical perspective, the timeline of events depicts rather dysfunctional societies unable to properly
communicate and organize themselves, leading to misallocation of resources and decisions that may have
conflicted with elementary ethical considerations, with this behavior rationalized by claiming adherence to
mental paradigms that may have poorly matched the situation. In summary, the pandemic response especially
in the United States and the European union appeared severely lacking. Further research on the details of
these processes is warranted.
Acknowledgments: the author wishes to thank Simon Barber for a grammar check.
Funding: None.
Conflict of Interest: None.
Ethical Approval: Not applicable.
32
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