Proxalutamide (GT0918) Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial
McCoy et al.,
Proxalutamide (GT0918) Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized..,
Frontiers in Medicine, doi:10.3389/fmed.2021.668698 (date from earlier preprint), NCT04446429
RCT 268 male patients in Brazil, 134 treated with proxalutamide, showing significantly lower hospitalization and mechanical ventilation.
NCT04446429 (history).
This paper was censored without details or author response, and the editors have ignored the authors, see
[].
risk of death, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 134 (0.0%), control 2 of 134 (1.5%), NNT 67, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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risk of mechanical ventilation, 97.1% lower, RR 0.03, p < 0.001, treatment 0 of 134 (0.0%), control 17 of 134 (12.7%), NNT 7.9, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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risk of hospitalization, 91.0% lower, RR 0.09, p < 0.001, treatment 3 of 134 (2.2%), control 35 of 134 (26.1%), NNT 4.2.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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McCoy et al., 30 Dec 2020, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 15 authors, trial
NCT04446429 (history).
Abstract: JEADV
COVID-19 SPECIAL FORUM
5-alpha-reductase inhibitors are
associated with reduced
frequency of COVID-19
symptoms in males with
androgenetic alopecia
Dear Editor
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-alphareductase 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 15
June to 28 July 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.
Among the men presenting at the clinic, 300 were positive for
SARS-CoV-2. Of these, 65 had AGA but were not using 5ARis,
and 48 had AGA and were taking a 5ARi for at least six months
prior to the study. The only 5ARi used in this cohort was dutasteride (0.5 mg) for the treatment of AGA. Propensity score
Table 1 Baseline characteristics of androgenetic alopecia men with COVID-19 by use and non-use of 5-alpha-reductase inhibitors
All SARS-CoV-2 positive
5ARi (n = 48)
Group-determing data, No (%)
Baseline data, No (%)
JEADV 2021, 35, e243–e307
No 5ARi (n = 48)
Androgenetic alopecia
48 (100)
48 (100)
Dutasteride use
48 (100)
0 (0)
Average Age, No.(SD)
45.6 (12)
45.7 (9)
BMI >30 kg/m2
9 (19)
8 (17)
Hypertension
12 (25)
11 (23)
Myocardial infarction
2 (4)
2 (4)
Stroke
0 (0)
0 (0)
Heart Failure
0 (0)
0 (0)
Lipid Disorder
24 (50)
17 (35)
Diabeties
9 (19)
5 (10)
Prediabeties
3 (6)
1 (2)
Obesity
9 (19)
8 (17)
Asthma
2 (4)
5 (10)
COPD
0 (0)
0 (0)
Cancer (current)
0 (0)
0 (0)
Cancer (previous)
0 (0)
1 (2)
Benign prostatic hyperplasia
5 (10)
2 (4)
Prostate Cancer
0 (0)
0 (0)
Chronic renal disease
0 (0)
0 (0)
Liver fibrosis/cirrhosis
0 (0)
0 (0)
Clinical depression
5 (10)
0 (0)
Anxiety
7 (15)
5 (10)
ADHD
6 (13)
4 (8)
Insomnia
5 (10)
2 (4)
Hypogonadism
3 (6)
4 (8)
Hypothyroidism
2 (4)
1 (2)
Autoimmune
0 (0)
0 (0)
Other Diseases
0 (0)
0 (0)
© 2020 European Academy of Dermatology and Venereology
Letters to the Editor
e244
Table 1 Continued
All SARS-CoV-2 positive
5ARi (n = 48)
No 5ARi (n = 48)
Medications used, No. (%)
Anti-hypertensives
Lipid-reducing agents
Anti-coagulants
Anti-diabetics
Hypothyroidism
Hypogonadism
Central-acting drugs
Androgenetic alopecia (others)
Beta-blocker
4 (8)
3 (6)
ECAi
5 (10)
4 (8)
Angiotensin II receptor blockers
9 (19)
9 (19)
Loop diuretics
1 (2)
0 (0)
Thiazide diuretics
4 (8)
4 (8)
Calcium channel blockers
6 (13)
4 (8)
K-sparing diuretics
0 (0)
1 (2)
Statins
23 (48)
14 (29)
Others
2 (4)
2 (4)
Aspirin
2 (4)
2 (4)
Clopidogrel
0 (0)
0 (0)
Xa factor inhibitors
3 (6)
0 (0)
Metformin
11 (23)
10 (21)
GLP1R analogue
3 (6)
2 (4)
SGLT2 inhibitors
5 (10)
2 (4)
DPP4 inhibitors
4 (8)
3 (6)
Sylfonylureas
1 (2)
0 (0)
Glitazone
0 (0)
1 (2)
Acarbose
0 (0)
0 (0)
Insulin
0 (0)
1 (2)
Orlistat
2 (4)
5 (10)
Levothyroxine
2 (4)
1 (2)
Liothyronine
0 (0)
0 (0)
Testosterone
1 (2)
4 (8)
Aromatase..
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treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation.
FLCCC and
WCH
provide treatment protocols.
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