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0 0.25 0.5 0.75 1 1.25 1.5 1.75 2+ Mortality 80% Improvement Relative Risk Mechanical ventilation 31% Hospital discharge -133% primary Hospitalization time -50% Mortality (b) 2% Mortality (c) 11% Mortality (d) -151% ICU admission -28% ICU admission (b) 13% ICU admission (c) 21% Hospitalization -23% Hospitalization (b) -24% Hospitalization (c) -40% c19early.com/welen.html Favors antiandrogen Favors control
14 December 2021 - Late treatment study
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 (Peer Reviewed)
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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.
Retrospective 7,894 COVID+ prostate cancer patients, analyzing patients on antiandrogen treatment, ADT, and ADT + abiraterone acetate or enzalutamide, showing mixed results and higher mortality for ADT + abiraterone acetate or enzalutamide.
In Vitro HBEC study showing no significant differences (p = 0.084).
The supplementary data is not currently available. NCT04475601.
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), RCT result.
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, RCT result.
risk of no hospital discharge, 132.6% higher, RR 2.33, p = 0.03, treatment 29, control 10, RCT result.
hospitalization time, 50.0% higher, relative time 1.50, p = 0.01, treatment 29, control 10.
risk of death, 2.0% lower, RR 0.98, p = 0.94, treatment 21 of 358 (5.9%), control 167 of 4,980 (3.4%), adjusted per study, retrospective study, antiandrogen treatment.
risk of death, 11.0% lower, RR 0.89, p = 0.66, treatment 20 of 334 (6.0%), control 167 of 4,980 (3.4%), adjusted per study, retrospective study, ADT.
risk of death, 151.0% higher, RR 2.51, p < 0.001, treatment 24 of 152 (15.8%), control 167 of 4,980 (3.4%), adjusted per study, retrospective study, ADT and abiraterone acetate or enzalutamide.
risk of ICU admission, 28.0% higher, RR 1.28, p = 0.28, treatment 24 of 358 (6.7%), control 216 of 4,980 (4.3%), adjusted per study, retrospective study, antiandrogen treatment.
risk of ICU admission, 13.0% lower, RR 0.87, p = 0.62, treatment 16 of 334 (4.8%), control 216 of 4,980 (4.3%), adjusted per study, retrospective study, ADT.
risk of ICU admission, 21.0% lower, RR 0.79, p = 0.60, treatment 6 of 152 (3.9%), control 216 of 4,980 (4.3%), NNT 256, adjusted per study, retrospective study, ADT and abiraterone acetate or enzalutamide.
risk of hospitalization, 23.0% higher, RR 1.23, p = 0.09, treatment 126 of 358 (35.2%), control 1,108 of 4,980 (22.2%), adjusted per study, retrospective study, antiandrogen treatment.
risk of hospitalization, 24.0% higher, RR 1.24, p = 0.09, treatment 126 of 334 (37.7%), control 1,108 of 4,980 (22.2%), adjusted per study, retrospective study, ADT.
risk of hospitalization, 40.0% higher, RR 1.40, p = 0.06, treatment 66 of 152 (43.4%), control 1,108 of 4,980 (22.2%), adjusted per study, retrospective study, ADT and abiraterone acetate or enzalutamide.
Effect extraction follows pre-specified rules prioritizing more serious outcomes.
Welén et al., 12/14/2021, Randomized Controlled Trial, Sweden, Europe, peer-reviewed, 27 authors, average treatment delay 9.5 days.
Contact: andreas.josefsson@umu.se.
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