Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial
| Autor: | John McCoy, Andy Goren, 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 |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
antiandrogens medicine.medical_specialty Medicine (General) Placebo-controlled study proxalutamide COVID-19 androgen receptor androgenetic alopecia anti-androgen therapy transmembrane protease serine 2 TMPRSS2 Placebo 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine R5-920 Internal medicine Clinical endpoint Medicine Adverse effect Original Research business.industry General Medicine Confidence interval Clinical trial 030104 developmental biology Clinical research Relative risk business |
| Zdroj: | Frontiers in Medicine, Vol 8 (2021) Frontiers in Medicine |
| ISSN: | 0444-6429 |
| Popis: | 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 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|