Frontiers in Medicine | |
Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial | |
Ricardo Ariel Zimerman1  Carlos Gustavo Wambier2  John McCoy3  Andy Goren3  Antonella Tosti4  Mirna Situm5  Maja Kovacevic5  Flávio Adsuara Cadegiani6  Sergio Vaño-Galván7  Daniel Fonseca8  Edinete Dorner8  Dirce Costa Onety8  Jerry Shapiro9  Andrija Stanimirovic1,10  Rodney Sinclair1,11  | |
[1] 0Hospital da Brigada Militar, Porto Alegre, Brazil;1Department of Dermatology, Alpert Medical School of Brown University, Providence, RI, United States;Applied Biology, Inc. Irvine, CA, United States;Department of Dermatology and Cutaneous Surgery, Miller School of Medicine, University of Miami, Miami, FL, United States;Department of Dermatology and Venereology, University Hospital Center “Sestre Milosrdnice”, Zagreb, Croatia;Department of Endocrinology, Corpometria Institute, Brasilia, Brazil;Dermatology Department, Ramón y Cajal Hospital, Madrid, Spain;Intensive Care Unit, Samel Hospital, Manaus, Brazil;Ronald O. Perelman Department of Dermatology, New York University School of Medicine, New York, NY, United States;School of Medicine, European University Cyprus, Nicosia, Cyprus;Sinclair Dermatology, Melbourne, VIC, Australia; | |
关键词: proxalutamide; COVID-19; androgen receptor; antiandrogens; androgenetic alopecia; anti-androgen therapy; | |
DOI : 10.3389/fmed.2021.668698 | |
来源: DOAJ |
【 摘 要 】
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.
【 授权许可】
Unknown