Proxalutamide (GT0918) Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial

Proxalutamide study #1 of 7 All Outcomes

12/30 Early treatment study

McCoy et al., Frontiers in Medicine, doi:10.3389/fmed.2021.668698 (preprint 12/30/2020) (Peer Reviewed)
Proxalutamide (GT0918) Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial

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RCT 268 male patients in Brazil, 134 treated with proxalutamide, showing significantly lower hospitalization and mechanical ventilation. NCT04446429.

McCoy et al., 12/30/2020, Double Blind Randomized Controlled Trial, Brazil, South America, peer-reviewed, 15 authors.

risk of death, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 134 (0.0%), control 2 of 134 (1.5%), continuity correction due to zero event (with reciprocal of the contrasting arm).

risk of mechanical ventilation, 97.1% lower, RR 0.03, p < 0.001, treatment 0 of 134 (0.0%), control 17 of 134 (12.7%), continuity correction due to zero event (with reciprocal of the contrasting arm).

risk of hospitalization, 91.0% lower, RR 0.09, p < 0.001, treatment 3 of 134 (2.2%), control 35 of 134 (26.1%).

Effect extraction follows pre-specified rules prioritizing more serious outcomes. For an individual study the most serious outcome may have a smaller number of events and lower statistical signficance, however this provides the strongest evidence for the most serious outcomes when combining the results of many trials.

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