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0 0.5 1 1.5 2+ Mortality 80% Improvement Relative Risk Ventilation 31% Discharge -133% primary Hospitalization time -50% c19early.com/aa Welén et al. NCT04475601 Enzalutamide RCT LATE TREATMENT Favors enzalutamide Favors control
Welén, 39 patient enzalutamide antiandrogen late treatment RCT: 80% lower mortality [p=0.26], 133% lower hospital discharge [p=0.03], and 50% longer hospitalization [p=0.01] https://c19p.org/welen
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A Phase 2 Trial of the Effect of Antiandrogen Therapy on COVID-19 Outcome: No Evidence of Benefit, Supported by Epidemiology and In Vitro Data
Welén et al., European Urology, doi:10.1016/j.eururo.2021.12.013
14 Dec 2021    Source   PDF   Share   Tweet
Very small late stage RCT with 10 control patients and 29 enzalutamide patients, showing mixed results. Discharge and hospitalization time favored the control group, while viral load reduction was better with treatment on days 4&6 (day 4 ΔCt −5.6 p = 0.084), and the only death occurred in the control group. 27% of enzalutamide patients had diabetes compared to 0% of the control group. This paper also includes a retrospective study which is listed separately, and an In Vitro HBEC study showing no significant differences (p = 0.084). The supplementary data is not currently available. NCT04475601.
For discussion of issues with this study see [sciencedirect.com, sciencedirect.com (B), sciencedirect.com (C), sciencedirect.com (D)].
risk of death, 79.6% lower, RR 0.20, p = 0.26, treatment 0 of 29 (0.0%), control 1 of 10 (10.0%), NNT 10.0, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of mechanical ventilation, 31.0% lower, RR 0.69, p = 1.00, treatment 2 of 29 (6.9%), control 1 of 10 (10.0%), NNT 32.
risk of no hospital discharge, 132.6% higher, RR 2.33, p = 0.03, treatment 29, control 10, primary outcome.
hospitalization time, 50.0% higher, relative time 1.50, p = 0.01, treatment 29, control 10.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Welén et al., 12/14/2021, Randomized Controlled Trial, Sweden, Europe, peer-reviewed, 27 authors, average treatment delay 9.5 days, trial NCT04475601.
Contact: andreas.josefsson@umu.se.
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