Cadegiani: Final Results of a Randomized, Placebo-Controlled, Two-Arm, Parallel Clinical Trial of Proxalutamide for Hospitalized COVID-19 Patients: A Multiregional, Joint Analysis of the Proxa-Rescue AndroCoV Trial

Cadegiani, 778 patient proxalutamide antiandrogen late treatment RCT: 78% lower mortality [p<0.0001], 45% improved recovery [p<0.0001], and 33% shorter hospitalization [p=0.0001] https://c19p.org/cadegiani10

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Final Results of a Randomized, Placebo-Controlled, Two-Arm, Parallel Clinical Trial of Proxalutamide for Hospitalized COVID-19 Patients: A Multiregional, Joint Analysis of the Proxa-Rescue AndroCoV Trial

Cadegiani et al., Cureus, doi:10.7759/cureus.20691, NCT04728802 (history)

25 Dec 2021 Source PDF Share Tweet

RCT 778 hospitalized patients in Brazil, 423 treated with proxalutamide, showing significantly lower mortality and improved recovery with treatment. NCT04728802 (history) and NCT05126628 (history). Authors note that cases in this trial were predominantly the P.1 Gamma variant, for which proxalutamide may be more effective compared to other variants.

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risk of death, 78.0% lower, RR 0.22, p < 0.001, treatment 45 of 423 (10.6%), control 171 of 355 (48.2%), NNT 2.7, adjusted per study, 28 days, Cox proportional hazards.

risk of death, 79.0% lower, RR 0.21, p < 0.001, treatment 34 of 423 (8.0%), control 138 of 355 (38.9%), NNT 3.2, adjusted per study, 14 days, Cox proportional hazards.

recovery rate, RR 0.55, p < 0.001, treatment 423, control 355, adjusted per study, inverted to make RR<1 favor treatment, 28 days, Cox proportional hazards.

recovery rate, RR 0.45, p < 0.001, treatment 423, control 355, adjusted per study, inverted to make RR<1 favor treatment, 14 days, Cox proportional hazards, primary outcome.

hospitalization time, 33.3% lower, relative time 0.67, p < 0.001, treatment 423, control 355.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Cadegiani et al., 25 Dec 2021, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 15 authors, trial NCT04728802 (history).

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This Paper Antiandrogens All

Late treatment
is less effective

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