RETRACTED: Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial
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 randomiz...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2021-07-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2021.668698/full |
| _version_ | 1797224831141281792 |
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| author | John McCoy Andy Goren Flávio Adsuara Cadegiani Flávio Adsuara Cadegiani Sergio Vaño-Galván Maja Kovacevic Mirna Situm Jerry Shapiro Rodney Sinclair Antonella Tosti Andrija Stanimirovic Daniel Fonseca Edinete Dorner Dirce Costa Onety Ricardo Ariel Zimerman Carlos Gustavo Wambier |
| author_facet | John McCoy Andy Goren Flávio Adsuara Cadegiani Flávio Adsuara Cadegiani Sergio Vaño-Galván Maja Kovacevic Mirna Situm Jerry Shapiro Rodney Sinclair Antonella Tosti Andrija Stanimirovic Daniel Fonseca Edinete Dorner Dirce Costa Onety Ricardo Ariel Zimerman Carlos Gustavo Wambier |
| author_sort | John McCoy |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T13:59:22Z |
| format | Article |
| id | doaj.art-badaaaba6d444997a71fcb964905cc00 |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-04-24T13:59:22Z |
| publishDate | 2021-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-badaaaba6d444997a71fcb964905cc002024-04-03T13:22:55ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2021-07-01810.3389/fmed.2021.668698668698RETRACTED: Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled TrialJohn McCoy0Andy Goren1Flávio Adsuara Cadegiani2Flávio Adsuara Cadegiani3Sergio Vaño-Galván4Maja Kovacevic5Mirna Situm6Jerry Shapiro7Rodney Sinclair8Antonella Tosti9Andrija Stanimirovic10Daniel Fonseca11Edinete Dorner12Dirce Costa Onety13Ricardo Ariel Zimerman14Carlos Gustavo Wambier15Applied Biology, Inc. Irvine, CA, United StatesApplied Biology, Inc. Irvine, CA, United StatesApplied Biology, Inc. Irvine, CA, United StatesDepartment of Endocrinology, Corpometria Institute, Brasilia, BrazilDermatology Department, Ramón y Cajal Hospital, Madrid, SpainDepartment of Dermatology and Venereology, University Hospital Center “Sestre Milosrdnice”, Zagreb, CroatiaDepartment of Dermatology and Venereology, University Hospital Center “Sestre Milosrdnice”, Zagreb, CroatiaRonald O. Perelman Department of Dermatology, New York University School of Medicine, New York, NY, United StatesSinclair Dermatology, Melbourne, VIC, AustraliaDepartment of Dermatology and Cutaneous Surgery, Miller School of Medicine, University of Miami, Miami, FL, United StatesSchool of Medicine, European University Cyprus, Nicosia, CyprusIntensive Care Unit, Samel Hospital, Manaus, BrazilIntensive Care Unit, Samel Hospital, Manaus, BrazilIntensive Care Unit, Samel Hospital, Manaus, Brazil0Hospital da Brigada Militar, Porto Alegre, Brazil1Department of Dermatology, Alpert Medical School of Brown University, Providence, RI, United StatesAntiandrogens 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.https://www.frontiersin.org/articles/10.3389/fmed.2021.668698/fullproxalutamideCOVID-19androgen receptorantiandrogensandrogenetic alopeciaanti-androgen therapy |
| spellingShingle | John McCoy Andy Goren Flávio Adsuara Cadegiani Flávio Adsuara Cadegiani Sergio Vaño-Galván Maja Kovacevic Mirna Situm Jerry Shapiro Rodney Sinclair Antonella Tosti Andrija Stanimirovic Daniel Fonseca Edinete Dorner Dirce Costa Onety Ricardo Ariel Zimerman Carlos Gustavo Wambier RETRACTED: Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial Frontiers in Medicine proxalutamide COVID-19 androgen receptor antiandrogens androgenetic alopecia anti-androgen therapy |
| title | RETRACTED: Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial |
| title_full | RETRACTED: Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial |
| title_fullStr | RETRACTED: Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial |
| title_full_unstemmed | RETRACTED: Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial |
| title_short | RETRACTED: Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial |
| title_sort | retracted proxalutamide reduces the rate of hospitalization for covid 19 male outpatients a randomized double blinded placebo controlled trial |
| topic | proxalutamide COVID-19 androgen receptor antiandrogens androgenetic alopecia anti-androgen therapy |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2021.668698/full |
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