COVID-19 Evidence Alerts
from McMaster PLUSTM

Current best evidence for clinical care (more info)

Treatment McCoy J, Goren A, Cadegiani FA, et al. Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial. Front Med (Lausanne). 2021 Jul 19;8:668698. doi: 10.3389/fmed.2021.668698. eCollection 2021.
Abstract

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.

Ratings
Discipline / Specialty Area Score
Internal Medicine
Infectious Disease
Family Medicine (FM)/General Practice (GP)
General Internal Medicine-Primary Care(US)
Comments from MORE raters

Family Medicine (FM)/General Practice (GP) rater

This may not be a generalisable finding and needs specialist review.

General Internal Medicine-Primary Care(US) rater

The important limitations in the procedures of the trial could make the astonishing differences between groups a very uncertain result.

General Internal Medicine-Primary Care(US) rater

Impressive results that need to be repeated. This is not “useful” information at this point.

Internal Medicine rater

Interesting and provocative but suffers from "too good to be true" bias. Nothing should be that effective. The RRR of 92% is just difficult to believe.

Internal Medicine rater

Would like to see this trial replicated before accepting it as proven care. The effect size is remarkably large and possibly implausible

Internal Medicine rater

A very important risk reduction.