Proxalutamide is a Potential Anti-Androgenic Therapeutic against COVID-19

The levels of ACE2 and TMPRSS2 which mediate the binding and entry of SARS-CoV-2 virus into the host are reduced by anti-androgens. Proxalutamide is a potent second-generation non-steroidal antiandrogen. It competitively inhibits androgen hormones from binding to the androgen receptors.

A double-blinded, randomized, placebo-controlled clinical trial was carried out to determine the effect of proxalutamide against COVID-19. 268 men above 18 years, diagnosed with mild COVID-19 participated in the study. 134 participants received 200 mg/day proxalutamide and the remaining 134 patients were treated using a 200mg/day of placebo for 7 days. The usual combinations of medications as per the COVID-19 protocols were continued for all patients. The patients were reviewed for 30 days post-randomization. The 30-day hospitalization rate was 2.2% in men taking proxalutamide compared to 26% in placebo. The 3 patients that were hospitalized in the proxalutamide group had later hospitalizations compared to the placebo group. The placebo group had a high rate of hospitalization in the first 10 days.

Gastrointestinal treatment emergent adverse effects like diarrhea (21% proxalutamide vs. 9% placebo), and nausea (14% proxalutamide vs. 6% placebo) were more frequent in the proxalutamide group. But, no deaths were reported in the proxalutamide group whereas, in the placebo arm two deaths were reported. The primary cause of death was reported as acute respiratory distress syndrome (ARDS) resulting from progressive COVID-19 disease.

Thus, proxalutamide reduced the rate of hospitalization by 91% in male COVID-19 outpatients. Proxalutamide is a potent therapeutic agent against COVID-19. Further clinical trials are required to optimise the dosage and analyse the safety of antiandrogens in female patients.

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