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0 0.5 1 1.5 2+ Mortality 80% Improvement Relative Risk Ventilation 31% Discharge -133% primary Hospitalization time -50% Enzalutamide  Welén et al.  LATE TREATMENT  RCT Is late treatment with antiandrogens beneficial for COVID-19? RCT 39 patients in Sweden (July 2020 - May 2021) Lower discharge (p=0.032) and longer hospitalization (p=0.01) Welén et al., European Urology, December 2021 Favors enzalutamide Favors control

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, NCT04475601
Dec 2021  
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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. 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 (history).
For discussion of issues with this study see, (B), (C), (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, inverted to make RR<1 favor treatment, 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., 14 Dec 2021, Randomized Controlled Trial, Sweden, peer-reviewed, 27 authors, study period 15 July, 2020 - 29 May, 2021, average treatment delay 9.5 days, trial NCT04475601 (history).
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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
Karin Welén, Ebba Rosendal, Magnus Gisslén, Annasara Lenman, Eva Freyhult, Osvaldo Fonseca-Rodríguez, Daniel Bremell, Johan Stranne, Åse Östholm Balkhed, Katarina Niward, Johanna Repo, David Robinsson, Anna J Henningsson, Johan Styrke, Martin Angelin, Elisabeth Lindquist, Annika Allard, Miriam Becker, Stina Rudolfsson, Robert Buckland, Camilla Thellenberg Carlsson, Anders Bjartell, Anna C Nilsson, Clas Ahlm, Anne-Marie Fors Connolly, Anna K Överby, Andreas Josefsson
European Urology, doi:10.1016/j.eururo.2021.12.013
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Author contributions: Andreas Josefsson had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
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Leach, Mohr, Giotis, The antiandrogen enzalutamide downregulates TMPRSS2 and reduces cellular entry of SARS-CoV-2 in human lung cells, Nat Commun
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Peckham, De Gruijter, Raine, Male sex identified by global COVID-19 meta-analysis as a risk factor for death and ITU admission, Nat Commun
Qiao, Wang, Mannan, Targeting transcriptional regulation of SARS-CoV-2 entry factors ACE2 and TMPRSS2, Proc Natl Acad Sci U S A
Schwartzberg, Elias, A phase I/Ib Study of enzalutamide alone and in combination with endocrine therapies in women with advanced breast cancer, Clin Cancer Res
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Welén, Rosendal, Gisslén, Lenman, Freyhult et al., Josefsson This study shows no effect of enzalutamide on hospitalized COVID-19 patients or a decrease in the risk of COVID-19 severity from any androgen-inhibiting drug in the population. Collectively, there is evidence of no beneficial role of androgen inhibition in COVID-19
Williamson, Walker, Bhaskaran, Factors associated with COVID-19-related death using OpenSAFELY, Nature
Zhang, Tan, Ling, Viral and host factors related to the clinical outcome of COVID-19, Nature
Late treatment
is less effective
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