Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients with Mild to Moderate COVID-19: Results from a Randomized, Double-Blinded, Placebo-Controlled Trial
Cadegiani et al.
, Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients..
, Cureus, doi:10.7759/cureus.13492
RCT 234 mild-moderate COVID-19 patients with 171 treated with proxalutamide, showing significantly faster viral clearance and recovery. Third party analysis suggests potential randomization failure: [steamtraen.blogspot.com]
This study is excluded in meta
potential randomization failure.
risk of no viral clearance, 92.1% lower, RR 0.08, p < 0.001, treatment 7 of 171 (4.1%), control 34 of 66 (51.5%), NNT 2.1, day 7, not including loss of taste or smell.
risk of no recovery, 76.8% lower, RR 0.23, p < 0.001, treatment 30 of 171 (17.5%), control 50 of 66 (75.8%), NNT 1.7, day 7, including loss of taste or smell.
recovery time, 85.0% lower, relative time 0.15, treatment 171, control 66, day 7, not including loss of taste or smell.
recovery time, 80.7% lower, relative time 0.19, treatment 171, control 66, day 7, including loss of taste or smell.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Cadegiani et al., 22 Feb 2021, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 8 authors, average treatment delay 4.2 days.
Abstract: Open Access Original
Proxalutamide Significantly Accelerates Viral
Clearance and Reduces Time to Clinical
Remission in Patients with Mild to Moderate
COVID-19: Results from a Randomized, DoubleBlinded, Placebo-Controlled Trial
Flavio A. Cadegiani 1, 2 , John McCoy 3 , Carlos Gustavo Wambier 4 , Sergio Vaño-Galván 5 , Jerry Shapiro 6 ,
Antonella Tosti 7 , Ricardo A. Zimerman 8 , Andy Goren 9
1. Internal Medicine: Diabetes and Endocrinology, Applied Biology Inc, Irvine, USA 2. Clinical Endocrinology, Federal
University of São Paulo, São Paulo, BRA 3. Research & Development, Applied Biology Inc, Irvine, USA 4. Dermatology,
The Alpert Medical School of Brown University, Providence, USA 5. Dermatology, Ramon y Cajal Hospital, Madrid, ESP
6. Ronald O. Perelman Department of Dermatology, New York University, New York, USA 7. Dermatology, University of
Miami Health System, Miami, USA 8. Infectious Diseases, Hospital da Brigada Militar, Porto Alegre, BRA 9.
Dermatology, Applied Biology Inc, Irvine, USA
Corresponding author: John McCoy, email@example.com
The entry of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) into type II pneumocytes is
dependent on a modification of viral spike proteins by transmembrane protease serine 2 (TMPRSS2)
expressed on the surface of human cells. TMPRSS2 is regulated by the androgen receptor, hence, SARS-CoV2 infectivity is indirectly dependent on androgenic status and phenotype. Previously, we have reported that
men affected by androgenetic alopecia (AGA) are overrepresented in severe coronavirus disease 2019
(COVID-19). Additionally, we have reported that men taking antiandrogenic drugs, e.g., 5-alpha-reductase
inhibitors (5ARis), are less likely to have severe COVID-19. Here we aimed to test whether the androgen
receptor antagonist, Proxalutamide, would be a beneficial treatment for subjects with SARS-CoV-2 infection.
Male and female subjects were recruited to a double-blinded, randomized, prospective, investigational study
of Proxalutamide for the treatment of COVID-19. Mild to moderate, non-hospitalized subjects, who were
confirmed positive for SARS-CoV-2, were treated with either Proxalutamide 200 mg/day or placebo.
Endpoints for the study were remission time (days) and the percentage of subjects confirmed negative for
SARS-CoV-2 on Day 7 after treatment. A negative SARS-CoV-2 test was defined by concentration-time
(Ct)>40 determined by real-time reverse transcription-polymerase chain reaction (rtPCR).
Review began 02/04/2021
Review ended 02/15/2021
© Copyright 2021
Cadegiani et al. This is an open access
article distributed under the terms of the
Creative Commons Attribution License
CC-BY 4.0., which permits unrestricted
Two-hundred thirty-six (2360 subjects were included in the study (108 female, 128 male); 171 were
randomized to the Proxalutamide arm and 65 were in the placebo group. On Day 7, SARS-CoV-2 became
non-detectable with rtPCR (cT>40) in 82% of the subjects in the Proxalutamide group versus 31% in the
placebo group (p < 0.001). The average clinical remission time for patients treated with Proxalutamide was
4.2 ±5.4 days versus 21.8 ±13.0 days in the placebo arm (p < 0.001).
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Proxalutamide significantly accelerated viral clearance on Day 7 in mild to moderate COVID-19..
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