Ivermectin as Pre-exposure Prophylaxis for COVID-19 among Healthcare Providers in a Selected Tertiary Hospital in Dhaka –An Observational Study

Abstract

Introduction: While multiple vaccines are undergoing clinical trial across the globe, we yearn for an FDA approved drug to protect us from the devastating pandemic for the time being. This study aims to determine the effectiveness of Ivermectin when administered as pre-exposure prophylaxis for COVID-19.
Method: An observational study, with 118 healthcare providers who were enrolled purposively, was conducted in a tertiary hospital in Dhaka from May 2020 to August 2020. The subjects were divided into experimental and control groups; and the experimental group received an oral monthly dose of Ivermectin 12mg for 4 months. Both groups were exposed to COVID-19 positive patients admitted in the hospital during the course of study. The symptomatic subjects were evaluated by physical examination, COVID-19 RT-PCR and/or HRCT of chest. Differences between the variables were determined using the Chi-square test and the level of statistical significance was reached when p<0.05.
Result: 73.3% (44 out of 60) subjects in control group were positive for COVID-19, whereas only 6.9% (4 out of 58) of the experimental group were diagnosed with COVID-19 (p-value < 0.05).
Conclusion: Ivermectin, an FDA-approved, safe, cheap and widely available drug, should be subjected to large-scale trials all over the world to ascertain its effectiveness as pre-exposure prophylaxis for COVID-19.

Full text

ORIGINAL ARTICLE
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DOI: http://dx.doi.org/10.24018/ejmed.2020.2.6.599
Vol 2 | Issue 6 | December 2020
1
I. BACKGROUND
Submerged in the wave of Coronavirus disease 2019
(COVID-19), the world is weeping. Ever since the outbreak
was first identified in December 2019 in Wuhan, China the
world has not been the same [1]. An ongoing pandemic, the
COVID-19 has proved to be the most devastating and
unmanageable crisis the world has ever encountered. With
the virus proudly lurking around in the atmosphere, millions
of lives have already been compromised and many more
uncountable innocents are still fighting to survive this war
against the invisible rival. The call for an authentic
treatment protocol against this virus was made long before
Ivermectin as Pre-exposure Prophylaxis for COVID-19
among Healthcare Providers in a Selected Tertiary
Hospital in Dhaka – An Observational Study
Mohammed Tarek Alam, Rubaiul Murshed, Pauline Francisca Gomes, Zafor Md. Masud, Sadia Saber,
Mainul Alam Chaklader, Fatema Khanam, Monower Hossain, Abdul Basit Ibne Momen, Naz Yasmin,
Rafa Faaria Alam, Amrin Sultana, and Rishad Choudhury Robin
ABSTRACT
Introduction: While multiple vaccines are undergoing clinical trial across
the globe, we yearn for an FDA approved drug to protect us from the
devastating pandemic for the time being. This study aims to determine the
effectiveness of Ivermectin when administered as pre-exposure prophylaxis
for COVID-19.
Method: An observational study, with 118 healthcare providers who were
enrolled purposively, was conducted in a tertiary hospital in Dhaka from
May 2020 to August 2020. The subjects were divided into experimental and
control groups; and the experimental group received an oral monthly dose
of Ivermectin 12mg for 4 months. Both groups were exposed to COVID-19
positive patients admitted in the hospital during the course of study. The
symptomatic subjects were evaluated by physical examination, COVID-19
RT-PCR and/or HRCT of chest. Differences between the variables were
determined using the Chi-square test and the level of statistical significance
was reached when p<0.05.
Result: 73.3% (44 out of 60) subjects in control group were positive for
COVID-19, whereas only 6.9% (4 out of 58) of the experimental group
were diagnosed with COVID-19 (p-value < 0.05).
Conclusion: Ivermectin, an FDA-approved, safe, cheap and widely
available drug, should be subjected to large-scale trials all over the world to
ascertain its effectiveness as pre-exposure prophylaxis for COVID-19.
Keywords: COVID-19, Ivermectin, Prophylaxis, Healthcare worker,
Bangladesh.
Published Online: December 15, 2020
ISSN: 2593-8339
DOI: 10.24018/ejmed.2020.2.6.599
Mohammed Tarek Alam*
Bangladesh Medical College Hospital,
Shomman Foundation, Bangladesh.
(e-mail: mtarekalam16 gmail.com)
Rubaiul Murshed
Shomman Foundation, Bangladesh.
Pauline Francisca Gomes
Shomman Foundation, Bangladesh.
Zafor Md. Masud
Bangladesh Medical College Hospital,
Shomman Foundation, Bangladesh.
Sadia Saber
Bangladesh Medical College Hospital,
Bangladesh.
Mainul Alam Chaklader
Bangladesh Medical College Hospital,
Bangladesh.
Fatema Khanam
Bangladesh Medical College Hospital,
Bangladesh.
Monower Hossain
Bangladesh Medical College Hospital,
Bangladesh.
Abdul Basit Ibne Momen
Bangladesh Medical College Hospital,
Shomman Foundation, Bangladesh.
Naz Yasmin
International Medical College,
Bangladesh.
Rafa Faaria Alam
Bangladesh Medical College Hospital,
Shomman Foundation, Bangladesh.
Amrin Sultana
Bangladesh Medical College Hospital,
Bangladesh.
Rishad Choudhury Robin
Shomman Foundation, Bangladesh.
*Corresponding Author
@

ORIGINAL ARTICLE
European Journal of Medical and Health Sciences
www.ejmed.org
DOI: http://dx.doi.org/10.24018/ejmed.2020.2.6.599
Vol 2 | Issue 6 | December 2020
2
the crisis was declared as a pandemic by World Health
Organization (WHO) [2]. However, as of date, no fixed
treatment protocol has proved efficacious enough to be
declared as the definitive cure for COVID-19. With
researchers across the globe striving to find a potent
medicine, doctors have resorted to empirical therapy and
symptomatic treatment to combat the disease. However, the
key to controlling this pandemic lies solely in stopping the
spread of the virus. While the search for an effective vaccine
is still underway, it is crucial for researchers and doctors to
find an alternative source of prevention using drugs that are
already widely available.
Among many drugs being tried and tested, Ivermectin has
proved its worth as a safe, efficacious, widely available,
potent anti-parasitic drug with multifaceted virucidal
properties including its newly studied effect against severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as
described by Caly et al. [3]. Based on this manuscript, we
had conducted an observational study from April 2020 to
May 2020 on 100 COVID-19 positive patients in Dhaka
who were treated with the combination of Ivermectin and
Doxycycline in which all the patients tested negative in RT-
PCR for COVID-19 by the end of the study. This finding,
although conducted in a small-scale, proves the capability of
Ivermectin in imposing anti-viral effects against the corona
virus [4].
The pioneering drug Ivermectin, is a dihydro derivative of
Avermectin which originated solely from a single
microorganism, Streptomyces avermitilis, isolated at the
Kitasato Institute, Tokyo, Japan by Satoshi Ōmura from
Japanese soil and since then, has had an astounding impact
in improving the lives and welfare of billions of people
across the globe, two of such accomplishments being its use
in combating the world’s most disfiguring, stigmatized
diseases- Onchocerciasis and Lymphatic Filariasis [5], [6].
Furthermore, Ivermectin has proved to be a potent
prophylactic drug against River blindness, loa and lymphatic
filariasis in several countries of Africa where the drug was
distributed through a mass donation program. In mid-to-late
1970s, Dr. William Campbell of Merck Research
Laboratories suggested the use of Ivermectin (later named
Mectizan) for River blindness in humans. In 1987, Merck
stepped forward in the mass donation of Ivermectin through
the Mectizan Donation Program (MDP) to the poverty-
stricken parts of the world with the goal to help eliminate
River blindness [7]. Later on, due to the MDP’s ground-
breaking success, mass administration of Ivermectin was
expanded to fight against Lymphatic Filariasis in African
countries and Yemen where it coexisted with River
Blindness. More than thirty years later, several countries in
Africa today are making significant progress towards
eliminating both diseases. Both River blindness and
Lymphatic Filariasis are on WHO’s list of Neglected
Tropical Diseases targeted for elimination globally [8]. The
program (MDP) reaches more than 300 million people in the
affected areas annually, with more than 3.4 billion
treatments donated since 1987. Moreover, treatment with
Ivermectin has been shown to significantly decrease Loa
microfilaraemia levels in patients by 90%; pre-treatment
testing was done to exclude those with high intensity
infections in order to avoid adverse effects [9]. Through
these effective mass-treatment programs, Ivermectin has
played a critical role in prophylaxis and elimination of River
blindness, lymphatic filariasis and low-intensity Loa [6],
[10].
This broad-spectrum anti-parasitic drug has exhibited
potent antiviral effects against several ribonucleic acid
(RNA) viruses, such as Zika virus, influenza A virus,
Venezuelan equine encephalitis virus, West Nile virus,
porcine reproductive and respiratory syndrome virus,
Newcastle disease virus, chikungunya virus, human
immunodeficiency virus (HIV-1), yellow fever virus,
dengue virus, Japanese encephalitis virus, and tick-borne
encephalitis virus [11]-[19]. Ivermectin has also exhibited
antiviral activity against deoxyribonucleic acid (DNA)
viruses, such as the pseudorabies virus, porcine circovirus 2,
parvoviruses and bovine herpesvirus 1 [20]-[23].
Considering its manifold uses, Ivermectin has indeed proved
its worth as “a wonder drug” [6].
Ivermectin has a plasma half-life of approximately 16-18
hours with wide tissue distribution, time-length ranging
from 4 days up to 12 days due to its high lipid solubility
[24]. Overall, the drug has potent anti-viral effects,
preventive capabilities, satisfactory tissue half-life and
minimum adverse effects. Compelled by this notion, we
have come forth with a research that tests the effectiveness
of the Food and Drug Administration (FDA) approved drug
Ivermectin in combatting the spread of the SARS-CoV-2 as
a pre-exposure prophylaxis for COVID-19.
II. METHODOLOGY
An observational study has been conducted in Bangladesh
Medical College Hospital (BMCH) from May 2020 to
August 2020 among healthy individuals working as
healthcare providers in COVID isolation unit. BMCH has
been purposively selected as a study site because it was a
prominent tertiary hospital of Dhaka which is the capital of
Bangladesh.
Total 118 healthy individuals working as healthcare
providers in COVID isolation wards in BMCH were
purposively enrolled in the study. The study group consisted
of doctors, interns, nurses, and attendants considering the
inclusion criteria which were individuals within the age
group of 21 years and 60 years and individuals who were
not under treatment with any antiviral drugs. Those who
were above 60 years of age and below 21 years of age,
pregnant women, or lactating mothers, had chronic liver
disease and individuals who were symptomatically ill were
excluded from the study.
The individuals were distributed into two groups
(experimental and control) comprising of 60 subjects in
control group and 58 subjects in experimental group. After
taking consent of the individuals under study, the
experimental group received a prophylactic dose of
Ivermectin 12 mg every 4 weeks for 4 months. During this
period all subjects from both groups were exposed to
COVID-19 reverse transcription polymerase chain reaction

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DOI: http://dx.doi.org/10.24018/ejmed.2020.2.6.599
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3
(RT-PCR) positive patients admitted in BMCH. The health
condition of the subjects was evaluated by assessing
symptomatic subjects through physical examination, and/or
RT-PCR for COVID-19 and/or High-resolution computed
tomography (HRCT) of chest throughout the study period of
4 months.
The data were analyzed using SPSS Version 20 for
Windows (IBM Corp., Armonk, NY, USA). Differences
between categorical variables were assessed for significance
using the Chi-square test. Gender, age, designation, smoking
habit, presence of comorbidities, exposure to COVID-19
positive family members, were confounders to determine the
significant association of variables with the outcome of
being healthy or acquiring COVID-19. The difference was
considered to be statistically significant were p<0.05.
III. RESULT
Out of the 118 participants’ majority were female. The
eldest subject was 60 years old and the youngest was 25
years of age with most participants between the ages of 25
to 40 years. The mean age of experimental group and
control group was 37.1 years and 36.7 years respectively. As
demonstrated in Table 1, the experimental group consisted
of a total of 58 participants with 16 (27.6%) males and 42
(72.4%) females, while the control group comprised of total
60 participants with 26 (43.3%) males and 34 (56.7%)
females. Among the participants there were 18 doctors, 10
interns, 18 nurses and 12 attendants in experimental group
and 11 doctors, 8 interns, 22 nurses and 19 attendants in
control group. There were 12 smokers and 46 non-smokers
in experimental group, and 13 smokers and 47 non-smokers
in control group. In the experimental group 20 (34.5%)
participants and in control group 18 (30%) participants had
comorbidities. History of exposure to COVID-19 positive
family members was found in 11 (19%) participants in
experimental group and 7 (12.1%) participants in control
group.
TABLE 1: DEMOGRAPHIC PROFILE (N=118)
Variables
Experimental Group
(n=58)
Control Group
(n=60)
p-value
Gender
Male (%)
16 (27.6%)
26 (43.3%)
0.06
Female (%)
42 (72.4%)
34 (56.7%)
Age (Mean)
37.1
36.7
Age Group (Years)
21-30
13 (22.4%)
21 (36.7%)
0.19
31-40
31 (53.4%)
21 (33.3%)
41-50
6 (10.3%)
10 (16.7%)
51-60
8 (13.8%)
8 (13.3%)
Designation
Doctor
18 (31.0%)
11 (18.3%)
0.28
Intern
10 (17.2%)
8 (13.3%)
Nurse
18 (31.0%)
22 (36.7%)
Attendant
12 (20.7%)
19 (31.7%)
Personal Habit
Smoker
12 (20.7%)
13 (21.7%)
0.54
Non-Smoker
46 (79.3%)
47 (78.3%)
Co-morbidities
Present
20 (34.5%)
18 (30%)
0.68
Absent
38 (65.5%)
42 (70%)
Exposure to COVID-19 positive family members
Present
11 (19%)
7 (12.1%)
0.20
Absent
47 (81%)
53 (88.3%)
Out of 58, 54 (93.1%) participants in experimental group
remained healthy despite being exposed to COVID-19 RT-
PCR positive patients. The remaining 4 participants (6.9%)
of the experimental group emerged symptomatic at the end
of the study; among them 3 were females (between age
group of 21-40 years) and 1 was male (age group 51-60
years). All 4 participants had mild symptoms with low grade
fever, dry cough, and weakness. Additionally, 2 of the 4
participants underwent HRCT of chest which showed
bilateral pulmonary infiltrates consistent with COVID-19.
On the contrary, the control group, who did not receive the
monthly prophylactic dose of Ivermectin from the start of
the trial period, a staggering 44 out of 60 participants
(73.3%) belonging to the control group emerged
symptomatic at different phases of the study period and
tested positive for COVID-19 in RT-PCR. Among the 44
symptomatic subjects, majority belonged to the age group
21-30 years and constituted of 84.6% (22 out of 26) males
(Fig. 1-3). Overall, as shown in Table 2, by the end of the
study 73.3% (44 out of 60) participants in control group
were positive for COVID-19, whereas only 6.9% (4 out of
58) of the experimental group were diagnosed with COVID-
19 which was statistically significant (p-value < 0.05).
TABLE 2: NUMBER OF COVID-19 AND HEALTHY CASES IN CONTROL AND
EXPERIMENTAL GROUP (N=118)
Groups
COVID-19
Healthy
p-value
Control Group
44 (73.3%)
16 (26.7%)
<0.05
Experimental Group
4 (6.9%)
54 (93.1%)
Fig. 1. RT-PCR positive samples among experimental group (n=58).
Fig.2. RT-PCR positive samples among control group (n=60).
12
29
67
1201
0
5
10
15
20
25
30
35
21-30 31-40 41-50 51-60
Age group /years
Healthy
COVID-19
1
11
4
0
20
10
6
8
0
5
10
15
20
25
21-30 31-40 41-50 51-60
Age group /years
Healthy
COVID-19

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Fig. 3. Frequency of COVID-19 and healthy participants according to
gender.
IV. DISCUSSION
Ivermectin, being a multifaceted medication, has proved
to be effective against various organisms [25]. Its safety and
efficacy coupled with its low adverse effects make this drug
a suitable candidate when orally prescribed. It has rapid oral
absorption, high lipid solubility and wide distribution in the
body [26]. Ivermectin was identified in late 1970s and first
approved for medical use in 1981 [25]. Over the years,
thorough studies revealed that Ivermectin possesses broad-
spectrum endo/ecto-parasiticide activity as well as antiviral,
antibacterial, and anticancer effects [3]. Moreover, this drug
causes immunomodulation in the host [27].
The causative agent of the current COVID-19 pandemic,
SARS-CoV2, is a single stranded positive sense Ribonucleic
acid (RNA) virus [28]. In a study, Vero-hSLAM cells were
treated with Ivermectin after 2 hours of SARS-CoV-2
infection, resulting in ~5000-fold reduction in viral RNA
after 48 hours. The study revealed that IMPα/β1 binds to the
coronavirus protein in the cytoplasm and translocate it into
the nucleus where the complex disintegrates, thus, freeing
the virus off the complex and enabling it to reduce the host
cell's antiviral response, leading to enhanced infection [3].
Ivermectin binds to the Impα/β1 heterodimer and
destabilizes it, thus preventing Impα/β1 from binding to the
viral protein and in the process preventing the virus from
entering the nucleus. This leads to decreased infection and
increased antiviral response [29].
As the COVID-19 cases surge across the globe, an actual
count of the infected still remains unknown due to the
alarming characteristic of the virus being spread by
individuals despite having mild or no symptoms [30]. This
phenomenon has led to the demand for a more collective
approach in combating this novel virus by incorporating
pharmacological treatment not only for active symptomatic
cases but also to prevent and mitigate the virus long before it
can initiate the disease process and cause further fatalities.
Therefore, as Ivermectin possesses potent anti-viral
properties and has also proved to be effective in preventing
and eliminating parasitic diseases by mass administration,
that too with negligible side effects, we hypothesized its
application for the prophylactic approach towards COVID-
19.
This study has shed a ray of light in portraying
Ivermectin’s astounding impact on preventing transmission
and contraction of COVID-19 in the most vulnerable setting
of a hospital among healthcare workers. Moreover, the
experimental group did not complain of any side effects or
breach of compliance regarding the dosing schedule.
However, we acknowledge that this trial has limitations.
This study was conducted in a small scale with limited
number of subjects being monitored over a short period of
time. Standard safety measurements being taken into
account, both of the study groups had variegated exposure to
COVID-19 positive patients of different severity levels
during the trial period. Also, due to the limited availability
of testing kits for COVID-19 RT-PCR, only the participants
who became symptomatic during the course of the study
were subjected to RT-PCR and/or HRCT of chest to confirm
the diagnosis. High-risk groups comprising of elders above
the age of 60, critically ill patients, patients with chronic
liver disease, pregnant and lactating women were not
included in the study. Despite being bound by these
limitations, our pragmatic approach to the study has
diligently paved its way towards a positive outcome. Safe,
cheap, and widely available, Ivermectin, is indeed a drug
that might save us all from this sinking ship. It is, therefore,
a worthy approach to expand the use of this drug for pre-
exposure prophylaxis of COVID-19.
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