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Finasteride in hospitalized adult males with COVID-19: A risk factor for severity of the disease or an adjunct treatment: A randomized controlled clinical trial

Authors:

Abstract

Background: There is controversy about the efficacy of 5-alpha-reductase inhibitors in COVID-19 patients. Some assumed that finasteride might be a risk factor for deterioration and others proposed it as a possible adjunct treatment for moderate to severe COVID-19 infection in the elderly. Methods: We performed a randomized controlled clinical trial (registration ID IRCT20200505047318N1) on 80 hospitalized male patients aged ≥50 years diagnosed with COVID-19 pneumonia in a tertiary hospital in Qazvin (Iran) from April to July 2020. The patients were randomized into one of the 2 treatment groups using simple randomization. Treatment group patients underwent routine drug therapy and 5 mg finasteride once daily for 7 days. The primary endpoint was mortality rate and length of hospital stay (LOS), and secondary endpoints were peripheral capillary oxygen saturation, respiratory rate, and inflammatory markers changes. The study protocol was approved by the medical ethics committee of Qazvin University of Medical Sciences (registration ID IR.QUMS.REC.1399.080). Data were analyzed by statistical tests and SPSS version 25. Also, p<0.05 was considered to be statistically significant. Results: We found a significant difference on O2 saturation among the 2 study groups on fifth day compared with the admission time (p= 0.018). The results did not show significant differences in mortality rate (2.5% vs 10%; p= 0.166) and LOS (p= 0.866) between patients in the finasteride and the control group. Conclusion: A short course of finasteride administration partially improves O2 saturation but does not influence other outcomes in hospitalized male patients aged ≥50 years with COVID-19 pneumonia. Further research in a large scale with longer follow-up is required to help clarify the role of finasteride in this setting.
Original Article
http://mjiri.iums.ac.ir
Medical Journal of the Islamic Republic of Iran (MJIRI)
Med J Islam Repub Iran. 2021(3 Mar);35.30. https://doi.org/10.47176/mjiri.35.30
______________________________
Corresponding author: Dr Abbas Allami, allami9@yahoo.com
1.
Department of Infectious Diseases, Clinical Research Development Unit, BouAli Sina
Hospital, Qazvin University of Medical of Sciences, Qazvin, Iran
2.
Qazvin Blood Transfusion Organization, Qazvin, Iran
3.
Children Growth Research Center, Research Institute for Prevention of N on-
Communicable Diseases, Qazvin University of Medical Sciences, Qazv in, Iran
4.
Canada Optimax Access Consultation, Ottawa, Canada
What is “already known” in this topic:
There is controversy about the efficacy of 5α-reductase
inhibitors in COVID-19 patients. Some assumed they might be
a risk factor for deterioration and others proposed it as a
possible adjunct treatment for moderate to severe COVID-19
infection in the elderly.
What this article adds:
This study is the first and only interventional research on
COVID-19 pneumonia outcome in hospitalized male patients
aged ≥50 years. A short course of finasteride administration
partially improves peripheral capillary O
2
saturation.
Finasteride in hospitalized adult males with COVID-19: A risk factor for
severity of the disease or an adjunct treatment: A randomized controlled
clinical trial
Elham Zarehoseinzade1, Abbas Allami1* , Mehrnoosh Ahmadi2, Behzad Bijani1, Navid Mohammadi3,4
Received: 29 Sep 2020 Published: 3 Mar 2021
Abstract
Background: There is controversy about the efficacy of 5-alpha-reductase inhibitors in COVID-19 patients. Some assumed that
finasteride might be a risk factor for deterioration and others proposed it as a possible adjunct treatment for moderate to severe
COVID-19 infection in the elderly.
Methods: We performed a randomized controlled clinical trial (registration ID IRCT20200505047318N1) on 80 hospitalized male
patients aged ≥50 years diagnosed with COVID-19 pneumonia in a tertiary hospital in Qazvin (Iran) from April to July 2020. The
patients were randomized into one of the 2 treatment groups using simple randomization. Treatment group patients underwent routine
drug therapy and 5 mg finasteride once daily for 7 days. The primary endpoint was mortality rate and length of hospital stay (LOS),
and secondary endpoints were peripheral capillary oxygen saturation, respiratory rate, and inflammatory markers changes. The study
protocol was approved by the medical ethics committee of Qazvin University of Medical Sciences (registration ID
IR.QUMS.REC.1399.080). Data were analyzed by statistical tests and SPSS version 25. Also, p<0.05 was considered to be statistically
significant.
Results: We found a significant difference on O
2
saturation among the 2 study groups on fifth day compared with the admission time
(p= 0.018). The results did not show significant differences in mortality rate (2.5% vs 10%; p= 0.166) and LOS (p= 0.866) between
patients in the finasteride and the control group.
Conclusion: A short course of finasteride administration partially improves O2 saturation but does not influence other outcomes in
hospitalized male patients aged ≥50 years with COVID-19 pneumonia. Further research in a large scale with longer follow-up is
required to help clarify the role of finasteride in this setting.
Keywords: Finasteride, Adult, Male, Therapy, COVID-19 Infection
Conflicts of Interest: None declared
Funding: Qazvin University of Medical Sciences (project number: 14004290).
*This work has been published under CC BY-NC-SA 1.0 license.
Copyright© Iran University of Medical Sciences
Cite this article as: Zarehoseinzade E, Allami A, Ahmadi M, Bijani B, Mohammadi N. Finasteride in hospitalized adult males with COVID-19: A
risk factor for severity of the disease or an adjunct treatment: A randomized controlled clinical trial. Med J Islam Repub Iran. 2021 (3 Mar);35:30.
https://doi.org/10.47176/mjiri.35.30
Introduction
In 2020, COVID-19 pneumonia has become a leading
cause of morbidity and mortality in many countries
worldwide, particularly among the elderly (1). Since
COVID-19 was first reported, a worldwide pandemic has
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ensued affecting more than 24 000 000 people as of Sep-
tember 2020. Only oxygen and other supportive care may
help improve outcomes in patients with COVID-19 pneu-
monia and rare pro
gress has been made in the treatment
of COVID patients (2).
During the Covid-19
pandemic, epidemiological reports
unveiled a disproportionate high rate of severe cases and
disease outcomes among adult males compared to adult
females (with short-term follow-up, males have 65%
higher mortality). Also, convalescence from COVID-19
among the elderly takes longer, and complications and
death are also more frequent than in younger adults (3, 4).
Research to date has not yet clearly determined the rea-
son for differences of COVID-19 infection severity and
outcome between adult females and males. This issue was
discussed theoretically in 4 earlier studies (5-8). These
studies have introduced the hypothesis that finasteride has
a beneficial or harm effect on clinical outcomes in adults
with COVID-19 pneumonia. Hoffmann et al propose that
the lower rate of severe COVID-19 infection in female
patients may be attributed to the molecular mechanism
required for SARS-CoV-2 infectivity (ie, lower androgen
receptor (AR) expression in females). SARS-CoV-2 cell
entry depends on priming of a viral spike surface protein
by transmembrane protease serine 2 (TMPRSS2) present
in type II pneumocytes (9). TMPRSS2 expression is asso-
ciated with an increase in AR expression, specifically
connecting AR expression to SARSCoV-2 due to AR-
regulated TMPRSS2 gene promoter (7, 10). Angiotensin-
converting enzyme 2 (ACE2) is the attachment molecule
to the viral spike surface protein “receptor of SARS-CoV-
2”. ACE2 activity has been shown to be reduced by the
decrease of androgen hormones, possibly due to decreased
expression of ACE2 (6). The US Food and Drug Admin-
istration (FDA) approved that 5-alpha reductase inhibitor
(finasteride) demonstrated reduction of activation of AR
in multiple tissues.
In another paper, authors assumed finasteride might in-
crease androgen concentration in lungs hampering their
regeneration. It might result in impairment of spontaneous
regeneration capacity and prolonged or deteriorated re-
covery prognosis. According to the presented hypothesis,
patients receiving 5-alpha-reductase inhibitors (5-ARIs)
might be vulnerable to COVID-19 infection with poorer
prognosis (5).
However, no observational or interventional studies on
the effect of finasteride on the treatment of COVID pneu-
monia was found in our literature review. Taken together,
the evidence warrants further studies to elucidate the role,
if any, of the AR on the severity of COVID-19 infection.
The study aim was to assess the influence of adjunctive
treatment with finasteride on the outcomes of hospitalized
adult male patients with COVID-19 pneumonia.
Methods
Study Design
We conducted a clinical randomized controlled trial in
hospitalized male patients aged 50 years or older, who are
predisposed to higher AR expression and may also be
suffering from benign prostatic hyperplasia (BPH), with
COVID-19 pneumonia. Patients were prospectively en-
rolled between May and June 2020 at BouAli Sina hospi-
tal (a tertiary referral center during the COVID19 out-
break), Qazvin, Iran. Patients were considered eligible if
they met the following criteria: (1) provided informed
consent; (2) had clinical symptoms suggestive of COVID-
19 pneumonia, including cough (with or without sputum),
fever, pleuritic chest pain, or dyspnea; (3) chest computed
tomography (CT) scan findings compatible with COVID-
19 or positive real time reverse transcription polymerase
chain reaction RT-PCR of COVID-19; (4) male patients
aged 50 years and older; and (5) moderate and sever dis-
ease.
Patients were excluded from the study if one of the fol-
lowing criteria applied: the presence of severe immuno-
suppression (eg, use of immunosuppressants); malignan-
cy; any likely infection other than COVID-19 pneumonia;
and indications that the patient was unable and/or unlikely
to comprehend and/or follow the protocol; liver function
abnormalities (as finasteride is metabolized extensively in
the liver); and a positive drug history of finasteride medi-
cation or hypersensitivity to any component of this medi-
cation. If there was any violation of the protocol, the pa-
tient was excluded from the final analysis.
We calculated that 40 patients were needed in both
groups to detect a mean difference of 2 days LOS (5±1.7
vs 7±1.7 days) between finasteride and control groups,
with a power of 80% and an alpha level of 0.05 (by statis-
tics and sample size calculator). Formula:
()
22
22
11
12
2
12
r
n
αβ
σ
σ
μμ


Ζ+Ζ +




Patients were randomly allocated into 2 therapeutic
groups in a 1:1 ratio to receive either only common care
based on “Iranian Guideline of Hospitalized COVID-19
Patients’ Management (V 5)” or common care plus finas-
teride (as adjuvant). The randomization sequence was
generated using Statistics and Sample Size application
version 1.0. A simple randomized list was produced for a
sample size of 80 and the participants were placed into 2
groups of case and control with numeric sequential unique
identifiers (simple or unrestricted randomization). Forty
patients in case group received a film coated tablet con-
taining 5 mg finasteride (Aburaihan pharmaceutical Co,
Iran) once daily for 7 days.
This study was a partial double-blind study. During the
treatment phase, the investigators could ascertain the pa-
tients’ study-drug assignment (only in the event of an
emergency). During the study, to minimize possible
sources of bias (ie, report more favorable outcomes or
even reporting subjective efficacy endpoints or adverse
effects in patients with previous experience of finasteride
and reporting treatment responses or adverse events by the
observer), patients and health care professionals who were
undertaking the outcome assessment of the primary out-
come were blinded to the group to which the subject was
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assigned.
Clinical data were measured at enrolment. Hypertension
was defined as an average systolic blood pressure (SBP)
greater than or equal to 140 mmHg or an average diastolic
blood pressure (DBP) greater than or equal to 90 mmHg,
or currently using blood pressure (BP)-lowering medica-
tion. A generalized formula of the mean arterial pressure
(MAP) is as follows:
MAP = DP+0.01x exp (4.14-40.74/HR) (SP-DP), where
HR is the heart rate (11).
All patients were treated according to “Iranian Guide-
line of Hospitalized COVID-19 Patients Management
(version 5)”. This comprised a heparin prophylaxis in
combination with a supplemental oxygen and intravenous
or oral fluid therapy. To avoid exaggerated estimates of
treatment effect, baseline and follow-up clinical and para-
clinical data measurement and recording were performed
by nurses with adequate experience. The investigators did
not influence decisions concerning discharge.
The primary endpoint was death/alive status and length
of hospital stay (LOS) and secondary endpoints were pe-
ripheral capillary oxygen saturation, respiratory rate, and
inflammatory markers changes. A CURB-65 severity
score was calculated, and 1 point was given for each fea-
ture present (range, 0–4 points) (12, 13). All patients were
observed and subsequently asked about adverse events.
Renal function assessment was performed on presentation.
Assessment of gas exchange requires knowledge of
fractional inspired oxygen tension (FiO2) unless the pa-
tient is breathing room air. Hence, all peripheral capillary
oxygen saturation was measured in breathing room air at
rest.
This trial was registered with the Iranian Registry of
Clinical Trials website (registration ID
IRCT20200505047318N1). The study protocol was ap-
proved by the medical ethics committee of Qazvin Uni-
versity of Medical Sciences (registration ID
IR.QUMS.REC.1399.080). All participants were provided
with information about the study’s purpose and gave in-
formed consent to participate in the study, according to
the principles of medical ethics of the World Health Or-
ganization and the seventh revision of the Declaration of
Helsinki 2008.
Statistical Analysis
The data were summarized as frequencies or percent-
ages for categorical variables and as medians and inter-
quartile ranges (IQR) (all the variable distributions were
skewed). We compared continuous variables using the
Mann-Whitney test and proportions using the χ2 test or
Fisher’s exact test. Moderation analyses were conducted
using the SPSS macro–PROCESS V 3.5. The PROCESS
macro produces bootstrapped unstandardized regression
output as well as estimates of the effect of the focal pre-
dictor variables (LOS and death/alive status) at values of
the moderator variables (ie, diabetes melitus) (14). P≤0.05
was considered statistically significant. The Statistical
Package for Social Sciences software, version 25.0
(SPSS®, Armonk, NY, USA) was used for data manage-
ment and statistical analysis.
Results
In this study, of the 90 hospitalized male patients diag-
nosed with COVID-19 pneumonia who met the inclusion
Fig. 1. Design Trial
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criteria, 8 were unwilling to continue the study. The re-
maining 82 patients were randomized, and 2 patients, one
in each group, were excluded due to a positive drug histo-
ry of finasteride. Data from the final 80 randomized pa-
tients were analyzed (Fig. 1). Demographic Information is
presented in Table 1.
Patients were evenly distributed in the 2 groups, except
those with diabetes mellites history; (5 [12.5%] vs 15
[37.5%] patients; p=0.020). Other clinical and paraclinical
features, such as Glasgow coma scale, peripheral capillary
oxygen saturation, white blood cell and platelet count, and
erythrocyte sedimentation rate, were not significantly dif-
ferent between the 2 groups (Table 1).
The results did not show significant differences in mor-
tality rate (1 [2.5%] vs 4 [10.0%]; p=0.166) and LOS
(p=0.866) between patients in the finasteride and the con-
trol groups (Table 2).
We found a significant difference in peripheral capillary
O2 saturation on the fifth day among the 2 study groups
(p=0.016) (Fig. 2).
The results of the binary logistic regression analysis and
linear regression analysis showed diabetes is not a signifi-
cant predictor of the outcome variables (for death/alive
status [model 1 Hayes: Y= death/alive status, X = group
and W = DM; p=0.989] and for LOS [model 1 Hayes: Y=
LOS, X = group and W = DM; p=0.398]).
Two patients developed hospital-acquired pneumonia
and were treated in the intensive care unit (one patient in
each group). Other patients in the finasteride group and in
the control group did not have any treatment-related ad-
verse events.
Discussion
To the best of our knowledge, this clinical trial study
was the first to examine the effects of finasteride as ad-
junctive therapy on outcome, hypoxia, and inflammatory
biomarkers in hospitalized adult male patients with
COVID-19 by assessing clinical and paraclinical parame-
ters. This study may help clinicians to optimize the
COVID infection management to decrease its mortality
and morbidity.
Only patient peripheral capillary O2 saturation on the
fifth day was significantly higher in the finasteride com-
pared with the control group. Finasteride could reduce
hypoxia-inducible factor-1alpha (HIF-1α), which reduces
vascular endothelial growth factor (VEGF), which in turn
reduces micro vessel density (MVD). Finasteride admin-
istration in BPH results in a statistically significant sup-
pression of hypoxia marker in BPH (HIF-1α expression)
(15).
Although a trend towards improved clinical outcomes
was observed in the finasteride group, these differences
were not statistically significant at day 5. Reduction in
LOS is an important goal in the treatment of patients with
COVID-19 pneumonia. In our study, the finasteride group
patients had not shorter LOS than control patients.
One hypothetical study assumed finasteride might be a
risk factor for deterioration of COVID-19 pneumonia in
the elderly (5) and 2 others proposed finasteride admin-
istration as a possible adjunctive treatment (6, 16). Based
Table 1. Baseline Characteristics and Severity Score in the Study Groups
Group
Characteristics Finasteride + Common
regimen (n=40)
Common regimen
(n=40)
Total (n=80) p
Age (year) 71 [62- 81] 72 [65- 77] 72 [64- 78] 0.904
Diabetes mellitus (%) 5 (12.5) 15 (37.5) 20 (25.0) 0.020*
Hypertension (%) 24 (60.0) 29 (72.5) 53 (66.3) 0.344
Cardiac disease (%) 17 (42.5) 14 (35.0) 31 (38.8) 0.646
Chronic obstructive pulmonary disease 3 (7.5) 7 (17.5) 10 (12.5) 0.310
Respiratory rate (breath/min) 18 [18- 20] 19 [18- 20] 19 [18- 20] 0.189
Systolic blood pressure (mmHg) 120 [120- 135] 130 [120- 140] 128 [120- 140] 0.265
Diastolic blood pressure (mmHg) 80 [70- 80] 80 [70- 90] 80 [70- 90] 0.426
Mean Arterial Pressure (mmHg) 96 [92- 103] 97 [91- 109] 96 [91- 106] 0.453
Pulse rate (beats/min) 90 [78- 100] 85 [81- 90] 88 [80- 95] 0.205
Temperature (°C) 36.8 [36.5- 37.8] 36.9 [36.5- 37.2] 36.8 [36.5- 37.4] 0.877
Peripheral capillary O
2
saturation 90 [84- 92] 89 [86- 92] 90 [85- 92] 0.806
Glasgow Coma Scale (GCS) ≤10 3 (7.5) 0 (0.0) 3 (3.9) 0.136
11-12 3 (7.5) 1 (2.5) 4 (5.1)
13-14 4 (10.0) 8 (20.0) 12 (15.0)
15 30 (75.0) 31 (77.5) 61 (76.3)
White blood cells (per mL) 8.0 [4.6- 11.4] 8.9 [6.8- 11.7] 8.4 [6.3- 11.6] 0.187
Absolute Lymphocyte count per μl) 1063 [797- 1441] 1144 [851- 1455] 1116 [821- 1455] 0.498
Platelets count (per ml) 159 [117- 234] 183 [134- 211] 162 [130- 223] 0.557
Erythrocyte sedimentation rate (mm/h) 29 [9- 45] 28 [15- 44] 28 [14- 44] 0.952
C-Reactive Protein (mg/dL) 23 [10- 40] 22 [6- 43] 23 [7- 42] 0.704
Blood Urea Nitrogen (mg/dL) 22 [17- 29] 23 [19- 29] 22 [18- 29] 0.512
Creatinine (mg/dL) 1.0 [0.9- 1.3] 1.1 [0.9- 1.3] 1.1 [0.9- 1.3] 0.615
Risk class (CURB-65) 0 7 (17.5) 1 (2.5) 8 (10.0) 0.443
1 12 (30.0) 16 (40.0) 28 (35.0)
2 18 (45.0) 23 (57.5) 41 (51.2)
3 3 (7.5) 0 (0.0) 3 (3.8)
n (%) or median [IQR]; IQR = Interquartile Range; CURB-65 = Mental Confusion; Urea >20 mg/dL; Respiratory Rate ≥30/min; Low Blood Pressure (diastolic blood
pressure ≤60 mm Hg or systolic blood pressure >90 mm Hg); Age ≥65 years; COVID-19 Pneumonia.
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ed J Islam Repub Iran. 2021 (3 Mar); 35.30.
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on our result, a short course administration of finasteride
does not seem to deteriorate outcomes of COVID-19
pneumonia in male adults but even improves peripheral
capillary O2 saturation. Two recent reports are compatible
with our study. In a recent retrospective cohort analysis on
male participants with laboratory confirmed SARSCoV2
infection, it was demonstrated that males using the 5-ARIs
display drastically reduced symptoms of COVID19 dis-
ease in an outpatient setting (17). Another prospective
cohort study was conducted from the data of men hospital-
ized due to COVID-19. The participants were categorized
into 2 cohorts: those taking antiandrogens for at least 6
months or those not taking antiandrogens prior to hospital-
ization. The participants were followed for a period of 60
days from the date of hospitalization. The relative risk for
ICU admission for those taking antiandrogens compared
with the age-matched group was RR 0.19 (16).
Adverse events related to treatment with finasteride in
our study were low and did not differ from the control
group. Adverse effects such as decrease in sexual and gen-
itourinary complications were reported with long-term
finasteride consumption; however, at recommended dos-
ages and duration, finasteride is well-tolerated. Finasteride
is generally well tolerated; adverse reactions are usually
mild and transient (18).
There are a number of limitations in the present study.
Table 2. Length of Hospital Stay, Outcome and Parameters of Disease Severity in Fifth Day Admission Among Male Adults With COVID-19 Pneu-
monia.
Group
n (%) or median [IQR]
Characteristics Finasteride Plus Common regime (n = 40) Common Regimen (n = 40) p
Respiratory rate (breath/min) 18 [17– 18] 18 [17– 18] 0.940*
Systolic blood pressure (mmHg) 115 [103– 120] 120 [110– 130] 0.090*
Diastolic blood pressure (mmHg) 70 [70– 80] 80 [70– 80] 0.074*
Pulse rate (beats/min) 79 [69– 84] 73 [66– 80] 0.126*
Temperature (°C) 36.7 [36.5– 36.8] 36.7 [36.5– 36.9] 0.731*
Peripheral capillary O
2
saturation 92 [89– 94] 89 [86– 92] 0.016*†
White blood cells (per μl) 7100 [5000– 9900] 6900 [5900– 8950] 0.773*
Absolute lymphocyte count (per μl) 1057 [630– 1491] 1312 [1062– 1440] 0.229*
Platelets count (per μl) 200 [165– 254] 195 [157– 237] 0.625*
Erythrocyte sedimentation rate (mm/h) 29 [13– 40] 28 [20– 44] 0.676*
C-Reactive Protein (mg/dL) 18 [5– 50] 28 [20– 40] 0.255*
Blood Urea Nitrogen (mg/dL) 18 [15– 31] 21 [15– 29] 0.602*
Creatinine (mg/dL) 1 [1– 1] 1 [1– 1] 0.670*
Length of hospital stay (day) 10 [6– 16] 10 [6– 14] 0.866*
Length of ICU stay (day) 0 [0– 0] 0 [0– 0] 0.902*
Length of intubation (day) 0 [0– 0] 0 [0– 0] 0.539*
Glasgow Coma Scale (GCS) ≤8 2 (5) 2 (5) 0.730**
9 to 14 8 (17.5) 7 (17.5)
15 31 (77.5) 31 (77.5)
Outcome discharge 39 (97.5) 36 (90) 0.166***
expire 1 (2.5) 4 (10)
* Mann-Whitney U test, ** χ
2
for linear trend, *** χ
2
test, † Significant, IQR = interquartile range.
Fig. 1. Box Plot of the peripheral capillary O
2
saturation trends during hospital admission for the 2 study groups
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Finasteride and in-hospital outcome of COVID-19
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ed J Islam Repub Iran. 2021 (3 Mar); 35:30.
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A limitation of the present study was that the finasteride
and dihydrotestosterone levels in our study population was
not directly assessed. The lack of a placebo group necessi-
tated a single-blind design, which may have influenced the
study outcomes. To prevent bias in parameter estimates,
health care professionals who were undertaking primary
outcome assessment did not have a priori knowledge of
group assignment (ie, partially blinded). In addition to,
patients took numerous medications. Also, the follow-up
period was short and in conditions such as COVID-19,
much longer periods are warranted to evaluate lasting
treatment effects. Furthermore, the follow-up period
lacked a control group because of funding constraints.
Additionally, although patients were usually discharged
when they reached the discharge criteria listed in the na-
tional COVID-19 guidelines, various comorbid disease of
patients and their socioeconomic status might influence
the decision-making of physicians.
Conclusion
A
short course of finasteride administration partially
improves peripheral capillary O
2
saturation but does not
influence other outcomes in hospitalized male patients
aged 50 years and older with COVID-19 pneumonia.
Further research in a large scale with longer follow-up is
required to help clarify the role of finasteride in the treat-
ment of COVID-19 pneumonia. Until then, we should be
cautious and not recommend routine administration of
finasteride for COVID-19 treatment.
Acknowledgements
The authors would like to thank the medical and nursing
staff at the BouAli Sina Medical Centre who participated
in the study.
Conflict of Interests
The authors declare that they have no competing interests.
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Downloaded from mjiri.iums.ac.ir at 15:38 IRST on Saturday February 27th 2021 [ DOI: 10.34171/mjiri.35.30 ]
... p = 0.0094) (12). Similarly, in a randomized clinical trial that enrolled 80 hospitalized men, the use of finasteride (a 5ARi with a shorter half-life than dutasteride) was associated with improvement in oxygen saturation by day 5, and a 75% lower mortality rate (13). ...
... More research is needed to elucidate the mechanism of NSAA and other antiandrogens on COVID-19. (25) Non-invasive ventilation 0 (0) 19 (14) High flow oxygen devices 1 (1) 26 (19) Invasive mechanical ventilation 0 (0) 17 (13) Extracorporeal membrane oxygenation 0 (0) 6 (4) ...
Article
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Antiandrogens have demonstrated a protective effect for COVOD-19 patients in observational and interventional studies. The goal of this study was to determine if proxalutamide, an androgen receptor antagonist, could be an effective treatment for men with COVID-19 in an outpatient setting. A randomized, double-blinded, placebo-controlled clinical trial was conducted at two outpatient centers (Brasilia, Brazil). Patients were recruited from October 21 to December 24, 2020 ( clinicaltrials.gov number, NCT04446429). Male patients with confirmed COVID-19 but not requiring hospitalization (COVID-19 8-point ordinal scale <3) were administered proxalutamide 200 mg/day or placebo for up to 7 days. The primary endpoint was hospitalization rate at 30 days post-randomization. A total of 268 men were randomized in a 1:1 ratio. 134 patients receiving proxalutamide and 134 receiving placebo were included in the intention-to-treat analysis. The 30-day hospitalization rate was 2.2% in men taking proxalutamide compared to 26% in placebo, P < 0.001. The 30-day hospitalization risk ratio was 0.09; 95% confidence interval (CI) 0.03–0.27. Patients in the proxalutamide arm more frequently reported gastrointestinal adverse events, however, no patient discontinued treatment. In placebo group, 6 patients were lost during follow-up, and 2 patients died from acute respiratory distress syndrome. Here we demonstrate the hospitalization rate in proxalutamide treated men was reduced by 91% compared to usual care.
... Therefore, COVID-19 in male patients with more advanced AGA is more likely to need more care or die (114). The newest clinical reports showed significant clinical symptoms of COVID-19 infection and a lower mortality rate in men patients undergoing androgen deprivation therapy (ADT) (109,(115)(116)(117). A recent finding showed that Proxalutamide could help nonhospitalized COVID-19 patients with mild to moderate symptoms to clear the virus much faster than those given a placebo (110,118). ...
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While the COVID-19 pandemic is expanding at an alarming rate, there is currently no treatment option for this disease. Therefore, it is necessary to find an effective treatment special for hospitalized COVID-19 patients at the earliest possible time. One of the promising options which should be investigated is the possible effects of old drugs or drug repositioning. This strategy has less risk with more economic advantages and can benefit the long-term control of this pandemic. Our study aimed to give an overview, update the current status of drug candidates (both virus-targeting and host-targeting drugs) for repurposing in COVID-19 infection, and assess the possible mechanism of their effect, in vivo antiviral efficacy, and clinical studies
... The majority of males infected with SARS-CoV-2 have androgenic alopecia, which is typically treated with androgens, and the authors suggest that finasteride may be more beneficial in this instance [133]. Regarding that, a short term of finasteride medication enhanced O2 sufficiency but had no effect on other outcomes in male patients over the age of 50, demanding a large-scale study with extended follow-up to elucidate the finasteride strategy [134]. Considering the common pathogenesis shared between AD and SARS-CoV-2, it was speculated that remedies for AD could be used as a possible treatment to prevent SARS-CoV-2, which in turn would alleviate COVID-19 outbreaks [3]. ...
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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been circulating since 2019, and its global dominance is rising. Evidences suggest the respiratory illness SARS-CoV-2 has a sensitive affect on causing organ damage and other complications to the patients with autoimmune diseases (AD), posing a significant risk factor. The genetic interrelationships and molecular appearances between SARS-CoV-2 and AD are yet unknown. We carried out the transcriptomic analytical framework to delve into the SARS-CoV-2 impacts on AD progression. We analyzed both gene expression microarray and RNA-Seq datasets from SARS-CoV-2 and AD affected tissues. With neighborhood-based benchmarks and multilevel network topology, we obtained dysfunctional signaling and ontological pathways, gene disease (diseasesome) association network and protein-protein interaction network (PPIN), uncovered essential shared infection recurrence connectivities with biological insights underlying between SARS-CoV-2 and AD. We found a total of 77, 21, 9, 54 common DEGs for SARS-CoV-2 and inflammatory bowel disorder (IBD), SARS-CoV-2 and rheumatoid arthritis (RA), SARS-CoV-2 and systemic lupus erythematosus (SLE) and SARS-CoV-2 and type 1 diabetes (T1D). The enclosure of these common DEGs with bimolecular networks revealed 10 hub proteins (FYN, VEGFA, CTNNB1, KDR, STAT1, B2M, CD3G, ITGAV, TGFB3). Drugs such as amlodipine besylate, vorinostat, methylprednisolone, and disulfiram have been identified as a common ground between SARS-CoV-2 and AD from drug repurposing investigation which will stimulate the optimal selection of medications in the battle against this ongoing pandemic triggered by COVID-19.
... In a study of 80 men hospitalised for COVID-19 randomised to finasteride added to routine treatment vs routine treatment alone, fewer finasteride-treated men died, albeit the results were not statistically significant (1/40 vs 4/40 men) (38). The COVIDENZA trial randomised women and men hospitalized with COVID-19 to enzalutamide and standard care (n = 30) vs standard care alone (n = 12) and was stopped early due to longer hospitalisations in the active arm (39). ...
Article
Full-text available
Objective Men are at greater risk from COVID-19 than women. Older, overweight men, and those with type 2 diabetes, have lower testosterone concentrations, and poorer COVID-19-related outcomes. We analysed associations of premorbid serum testosterone concentrations, not confounded by effects of acute SARS-CoV-2 infection, with COVID-19-related mortality risk in men. Design UK Biobank prospective cohort study of community-dwelling men aged 40-69 years. Methods Serum total testosterone and sex hormone-binding globulin (SHBG) were measured at baseline (2006-2010). Free testosterone values were calculated (cFT). Incidence of SARS-CoV-2 infections and deaths related to COVID-19 were ascertained from 16 March 2020-31 January 2021, and modelled using time-stratified Cox regression. Results In 159,964 men there were 5,558 SARS-CoV-2 infections and 438 COVID-19 deaths. Younger age, higher body mass index, non-white ethnicity, lower educational attainment, and socio-economic deprivation were associated with incidence of SARS-CoV-2 infections, but total testosterone, SHBG, and cFT were not. Adjusting for potential confounders, higher total testosterone was associated with COVID-19-related mortality risk (overall trend P=0.008; hazard ratios, HR [95% confidence intervals] quintile 1, Q1 vs Q5 [reference]: 0.84 [0.65-1.12], Q2:Q5 0.82 [0.63-1.10], Q3:Q5 0.80 [0.66-1.00], Q4:Q5 0.82 [0.75-0.93]). Higher SHBG was also associated with COVID-19 mortality risk (P=0.008), but cFT was not (P=0.248). Conclusions Middle-aged to older men with the highest premorbid serum total testosterone and SHBG concentrations are at greater risk of COVID-19-related mortality. Men could be advised that having relatively high serum testosterone concentrations does not protect against future COVID-19-related mortality. Further investigation of causality and potential underlying mechanisms is warranted.
... Finally, the protective effects of MRAs against tissue fibrosis, inflammation, and vascular dysfunction have been implicated in potentially attenuating the severity of SARS-CoV-2 infection by inhibiting aldosterone [33,42,43]. Previous authors have hypothesized that spironolactone, a type of MRA, may have a beneficial effect on SARS-CoV-2 outcomes through its dual action as an MRA and antiandrogen, resulting in reduced TMPRSS2-related viral entry [38,44,45]. In animal models, spironolactone was also associated with reduction in oxidative stress and lung injury and has been considered a possible therapy in the treatment of COVID-19-related pulmonary fibrosis [42,46,47]. ...
Article
Full-text available
Since the onset of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, various potential targeted therapies for SARS-CoV-2 infection have been proposed. The protective effects of mineralocorticoid receptor antagonists (MRA) against tissue fibrosis, pulmonary and systemic vasoconstriction, and inflammation have been implicated in potentially attenuating the severity of SARS-CoV-2 infection by inhibiting the deleterious effects of aldosterone. Furthermore, spironolactone, a type of MRA, has been suggested to have a beneficial effect on SARS-CoV-2 outcomes through its dual action as an MRA and antiandrogen, resulting in reduced transmembrane protease receptor serine type 2 (TMPRSS2)-related viral entry to host cells. In this study, we sought to investigate the association between MRA antagonist therapy and mortality in SARS-CoV-2 patients via systematic review and meta-analysis. The systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE and EMBASE databases were searched for studies that reported the incidence of mortality in patients on MRA with SARS-CoV-2 infection. Pooled odds ratio (OR) and 95% confidence interval (CI) of the outcome were obtained using the random-effects model. Five studies with a total of 1,388,178 subjects (80,903 subjects receiving MRA therapy) met the inclusion criteria. We included studies with all types of MRA therapy including spironolactone and canrenone and found no association between MRA therapy and mortality in SARS-CoV-2 infection (OR = 0.387, 95% CI: 0.134–1.117, p = 0.079).
... An independent RCT on finasteride for hospitalized COVID-19 subjects identified that finasteride statistically significantly improved oxygen parameters and a numerical reduction of 75% in mortality rate [63]. Coincidently, this RCT was not included in the discussion of the results of the COVIDENZA trial. ...
Preprint
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Dear all, I read with interest an article of a pilot open label trial randomized clinical trial (RCT) that tested enzalutamide, an anti-androgen, in hospitalized COVID-19 patients (The ‘COVIDENZA’ trial [1]. I also read with interest the two letters to the editor [2,3] regarding this article and their respective responses from the authors of the study [4,5]. These readings, in combination with additional factors that will be listed and described below, generated an intriguing question regarding the underlying impartiality and symmetry required for RCTs in the case of COVIDENZA. Critical concerns were raised from the thread of coincidental detections from the trial, and require further clarification, rectifications, and other actions. There extensive number of concerns can be better understood if they are ordered in a logical, intuitive manner, that must be depicted individually. A total of 21 concerns and their portrayal are described. Figure 1 summarizes the concerns regarding the RCT discussed in this trial and Figure 2 summarizes the supporting data for each of the concerns. Unexpectedly, after the critical issues have been raised, the editorial board of the journal where the trial was published – European Urology (Platinum) – decided to close the case without further explanations. They also refused to respond to any of my questions. These actions should promptly raise questions regarding the journal’s editorial integrity. An article published in 2019 in Science discusses this point from an interesting perspective and reinforces the concerns not only over the trial, but also over the editorial team from the journal1. At the end of this documents (after the references), the e-mails exchanged between the author of this article and the European Urology editorial team can be found. These e-mails allow conclusive confirmations of the allegations from the author of this article. 1https://www.science.org/content/article/major-medical-journals-don-t-follow-their-own-rules-reporting-results-clinical-trials
... These findings support the hypothesis that antiandrogens could be effective against COVID-19 with observational and RCTs in early COVID-19 have demonstrated that dutasteride, spironolactone and proxalutamide could protect against COVID-19 disease progression [190][191][192][193][194][195]. These benefits have also been observed in hospitalized patients through RCTs for finasteride and proxalutamide [191,193,194,196,197]. Thus, the strong biological plausibility of androgen-dependent mechanisms of SARS-CoV-2 cell invasion, the multiple corresponding epidemiological observations in both excess and blockage of androgen activity, observational, and several RCTs demonstrating the efficacy of a variety of anti-androgens in preventing COVID-19 disease progression support the recommendation for their use during hospitalization. ...
Article
Full-text available
In December 2019, coronavirus disease 2019 (COVID-19), a severe respiratory illness caused by the new coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in Wuhan, China. The greatest impact that COVID-19 had was on intensive care units (ICUs), given that approximately 20% of hospitalized cases developed acute respiratory failure (ARF) requiring ICU admission. Based on the assumption that COVID-19 represented a viral pneumonia and no anti-coronaviral therapy existed, nearly all national and international health care societies recommended "supportive care only" avoiding other therapies outside of randomized controlled trials, with a specific prohibition against the use of corticosteroids in treatment. However, early studies of COVID-19-associated ARF reported inexplicably high mortality rates, with frequent prolonged durations of mechanical ventilation (MV), even from centers expert in such supportive care strategies. These reports led the authors to form a clinical expert panel called the Front-Line COVID-19 Critical Care Alliance (www.flccc.net). The panel collaboratively reviewed the emerging clinical, radiographic, and pathological reports of COVID-19 while initiating multiple discussions among a wide clinical network of front-line clinical ICU experts from initial outbreak areas in China, Italy, and New York. Based on the shared early impressions of "what was working and what wasn't working", the increasing medical journal publications and the rapidly accumulating personal clinical experiences with COVID-19 patients, a treatment protocol was created for the hospitalized patients based on the core therapies of methylprednisolone, ascorbic acid, thiamine, heparin and non-antiviral co-interventions (MATH+). This manuscript reviews the scientific and clinical rationale behind MATH+ based on published in-vitro, pre-clinical, and clinical data in support of each medicine, with a special emphasis of studies supporting their use in the treatment of patients with viral syndromes and COVID-19 specifically.
Article
Background and aim: by the end of December 2019 new corona virus began to spread from Wuhan, China and caused a worldwide pandemic. COVID-19 deaths and prevalence represented sex discrepant patterns with higher rate of deaths and infection in males than females which could be justified by androgen-mediated mechanisms. this review aimed to assess the role of androgens in COVID-19 severity and mortality Discussion: androgens increase expression of Type II transmembrane Serine Protease (TMPRSS2) and Angiotensin Converting Enzyme 2 (ACE2) which both facilitate new corona virus entry into host cell and their expression is higher in young males than females. According to observational studies, prevalence of COVID-19 infections and deaths was more in androgenic alopecic patients than patients without androgenic alopecia. The COVID-19 mortality rates in aged men (>60 years) was substantially higher than aged females and even young males caused by high inflammatory activities such as cytokine storm due to hypogonadism in this population. Use of anti-androgen and TMPRSS2 inhibitor drugs considerably modified COVID-19 symptoms. androgen deprivation therapy also improved COVID-19 symptoms in prostate cancer: overall the role of androgens in severity of COVID-19 and its associated mortality seemed to be very important . So more studies in variety of populations are required to define the absolute role of androgens.
Article
Introduction Up to now, numerous randomized controlled trials (RCTs) have examined various drugs as possible treatments for Coronavirus Disease 2019 (COVID-19), but the results were diverse and occasionally even inconsistent with each other. To this point, decisive consensus on treatment is requiring. Therefore, we performed a systematic review and meta-analysis (SR-MAs) to assess the comparative effectiveness of pharmacological agents in published RCTs. Areas covered A literature search was performed using PubMed, SCOPUS, EMBASE, and Web of Science databases. RCTs evaluating mortality and the average length of hospital stay to standard of care (SOC)/placebo/control were included in our meta-analysis. RCTs mainly were classified into five categories of drugs, including anti-inflammatory, antiviral, antiparasitic, antibody and antibiotics. Meta-analysis was done on 5 drugs classes and sub-group meta-analysis was done on single drugs and moderate or severe stage of disease. Expert opinion : Mortality and the average length of hospital stay of COVID-19 patients was significantly reduced with anti-inflammatory drugs (odds ratio [OR]: 0.77, 95% confidence interval [CI]: 0.69 to 0.85, P<0.00001, and mean difference [MD]: -1.41, CI:-1.75 to -1.07, P<0.00001, respectively) compared to SOC/control/placebo. Furthermore, antiparasitic was associated with reduced length of hospital stay (MD: -0.65, CI: -1.26 to -0.03, P<0.05) in comparison to SOC/placebo/control. However, no difference was found in other pharmacological interventions in comparison to SOC/placebo/control in outcomes.
Article
Full-text available
In this communication, we present arguments for androgen sensitivity as a likely determinant of COVID‐19 disease severity. The androgen sensitivity model explains why males are more likely to develop severe symptoms while children are ostensibly resistant to infection. Further, the model explains the difference in COVID‐19 mortality rates among different ethnicities. Androgen sensitivity is determined by genetic variants of the androgen receptor. The androgen receptor regulates transcription of the transmembrane protease, serine 2 (TMPRSS2), which is required for SARS‐CoV‐2 infectivity. TMPRSS2 primes the Spike protein of the virus, which has two consequences: diminishing viral recognition by neutralizing antibodies and activating SARS‐CoV‐2 for virus‐cell fusion. Genetic variants that have been associated with androgenetic alopecia, prostate cancer, benign prostatic hyperplasia and polycystic ovary syndrome could be associated with host susceptibility. In addition to theoretical epidemiological and molecular mechanisms, there are reports of high rates of androgenetic alopecia of from hospitalized COVID‐19 patients due to severe symptoms. Androgen sensitivity is a likely determinant of COVID‐19 disease severity. We believe that the evidence presented in this communication warrants the initiation of trials using anti‐androgen agents.
Article
We have previously reported that men with androgenetic alopecia (AGA) are more likely to present with severe COVID-19 symptoms, potentially implicating androgen sensitivity as a risk factor for COVID-19.1-3 As such, we hypothesized that 5-alpha-reductase inhibitors (5ARi) may reduce the severity of COVID-19 disease. To test this hypothesis we conducted a retrospective cohort analysis on male subjects with laboratory confirmed SARS-CoV-2 infection. The subjects presented at one of five outpatient clinics (Corpometria Institute Brasilia, Brazil) from June 15 to July 28, 2020. At the time of visit, 29 clinical symptoms associated with SARS-CoV-2 infection were documented. For analysis, male subjects with AGA were selected. The frequency of clinical symptoms in males with AGA using 5ARis was compared to those not using 5ARis.
Article
The COVID-19 pandemic has disproportionally affected men.1 Men infected with SARS-CoV-2 are more than twice as likely to be admitted to the intensive care unit (ICU).2 This disparity in ICU admissions suggests the important role of androgens in COVID-19 severity.3 Previously, we reported that among 122 men hospitalized due to COVID-19, 79% were diagnosed with androgenetic alopecia (AGA),4 which is commonly treated with anti-androgens. Anti-androgens commonly used in the treatment of AGA such as finasteride, dutasteride, spironolactone, and bicalutamide could improve outcomes among men infected by SARS-CoV-2.
Article
COVID-19 pandemic is a major challenge for global and national healthcare providers. Number of new cases is continuously increasing with an emerging trend showing worse prognosis in males in comparison to females. Based on this observation, our proposed hypothesis is that 5-alpha-reductase inhibitors, that are commonly used for BPH treatment, may be one of the factors contributing to poorer prognosis in males. Background With increasing number of COVID-19 cases, an evident sex- dependent difference in disease outcomes can be observed. Based on published studies with short term follow-up, males have 65% higher mortality rate (1). The question remains, whether long term observational studies will confirm improved recovery in females.
Article
Background: To study the clinical data, discharge rate, and fatality rate of COVID-19 patients for clinical help. Methods: The clinical data of COVID-19 patients from December 2019 to February 2020 were retrieved from four databases. We statistically analyzed the clinical symptoms and laboratory results of COVID-19 patients and explained the discharge rate, fatality rate with a single-arm meta-analysis. Results: The available data of 1994 patients in 10 literatures were included in our study. The main clinical symptoms of COVID-19 patients were fever (88.5%), cough (68.6%), myalgia or fatigue (35.8%), expectoration (28.2%), dyspnea (21.9%). Minor symptoms include headache or dizziness: (12.1%) diarrhea (4.8%), nausea, and vomiting (3.9%). The results of laboratory results showed that the lymphocytopenia (64.5%), increase of CRP (44.3%), increase of LDH (28.3%), and leukocytopenia (29.4%) were more common. Conclusions: The results of single-arm meta-analysis showed that: the male took a larger percentage in the gender distribution of COVID-19 patients 60%[95%CI (0.54,0.65)], the discharge rate of COVID-19 patients was 42%[95%CI (0.29,0.55)], and the fatality rate was 7%[95%CI (0.04,0.10)]. This article is protected by copyright. All rights reserved.
Article
The recent emergence of the novel, pathogenic SARS-coronavirus 2 (SARS-CoV-2) in China and its rapid national and international spread pose a global health emergency. Cell entry of coronaviruses depends on binding of the viral spike (S) proteins to cellular receptors and on S protein priming by host cell proteases. Unravelling which cellular factors are used by SARS-CoV-2 for entry might provide insights into viral transmission and reveal therapeutic targets. Here, we demonstrate that SARS-CoV-2 uses the SARS-CoV receptor ACE2 for entry and the serine protease TMPRSS2 for S protein priming. A TMPRSS2 inhibitor approved for clinical use blocked entry and might constitute a treatment option. Finally, we show that the sera from convalescent SARS patients cross-neutralized SARS-2-S-driven entry. Our results reveal important commonalities between SARS-CoV-2 and SARS-CoV infection and identify a potential target for antiviral intervention.