Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial

Frontiers in Medicine

article

John McCoy¹  Andrija Stanimirovic²  Daniel Fonseca³  Edinete Dorner³  Dirce Costa Onety³  Ricardo Ariel Zimerman⁴  Carlos Gustavo Wambier⁵  Andy Goren¹  Flávio Adsuara Cadegiani¹  Sergio Vaño-Galván⁷  Maja Kovacevic⁸  Mirna Situm⁸  Jerry Shapiro⁹  Rodney Sinclair^1,10  Antonella Tosti^1,11 

[1] Inc. Irvine, United States;School of Medicine, European University Cyprus;Intensive Care Unit, Samel Hospital;Hospital da Brigada Militar;Department of Dermatology, Alpert Medical School of Brown University, United States;Department of Endocrinology, Corpometria Institute;Dermatology Department, Ramón y Cajal Hospital;Department of Dermatology and Venereology, University Hospital Center “Sestre Milosrdnice”;Ronald O. Perelman Department of Dermatology, New York University School of Medicine, United States;Sinclair Dermatology;Department of Dermatology and Cutaneous Surgery, Miller School of Medicine, University of Miami, United States

关键词: proxalutamide;    COVID-19;    androgen receptor;    antiandrogens;    androgenetic alopecia;    anti-androgen therapy;    transmembrane protease serine 2;    TMPRSS2;   

DOI  :  10.3389/fmed.2021.668698

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 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, {"type":"clinical-trial","attrs":{"text":"NCT04446429","term_id":"NCT04446429"}} 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】

CC BY