Importance: Previously, we have reported a retrospective cohort analysis demonstrating the protective effect of anti-androgens (5-alpha-reductase inhibitors) in COVID-19.
Objective: To determine if the anti-androgen proxalutimide is an effective treatment for men with ambulatory mild COVID-19 disease.
Design: A double-blinded, randomized, prospective, investigational study of proxalutamide for the treatment men with ambulatory mild COVID-19 disease.
Setting: Outpatient centers (Brasilia, Brazil) from July 15 to December 1, 2020.
Participants: Men with ambulatory mild COVID-19 disease (WHO ordinal scale ≤3).
Interventions: Proxalutimide 200mg/day, or standard of care for 30 days or until full COVID-19 remission.
Main Outcome and Measures: Percentage of subjects hospitalized due to COVID-19 [Time Frame: 30 days].
Results: A total of 214 men were included and completed the trial; 114 men were randomized to the proxalutamide group, and 100 men were randomized to the control group. A statistically significant reduction in the percentage of subjects hospitalized due to COVID-19 was observed in men taking proxalutamide (0%) compared to the standard of care (27%), (p<0.001). The percentage of men requiring mechanical ventilation was reduced in the proxalutamide group (0%) compared to control (9%), (p<0.001). Zero fatalities occurred in the proxalutamide group, versus 2 in the control group.
Conclusions and Relevance: Men with ambulatory mild COVID-19 disease (WHO ordinal scale ≤3) receiving anti-androgen treatment with proxalutamide, had significantly reduced rate of hospitalization compared to men not receiving anti-androgen treatment.
Trial Registration: NCT04446429