Naslov
Proxalutamide reduces the rate of hospitalization for COVID-19 male outpatients: a randomized double-blinded placebo-controlled trial

Autori
McCoy, John ; Goren, Andy ; Adsuara Cadegiani, Flávio ; Vaño-Galván, Sergio ; Kovačević, Maja ; Šitum, Mirna ; Shapiro, Jerry ; Sinclair, Rodney ; Tosti, Antonella ; Stanimirović, Andrija ; Fonseca, Daniel ; Dorner, Edinete ; Costa Onety, Dirce ; Ariel Zimerman, Ricardo ; Wambier, Carlos Gustavo

Izvornik
Frontiers in medicine (2296-858X) 8 (2021); 668698, 7

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
proxalutamide ; COVID-19 ; androgen receptor ; antiandrogens ; androgenetic alopecia ; anti-androgen therapy ; transmembrane protease serine 2 ; TMPRSS2

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

POVEZANOST RADA