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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
Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Section of Virology. Umeå University, Faculty of Medicine, Molecular Infection Medicine Sweden (MIMS).ORCID iD: 0000-0001-8512-0535
Umeå University, Faculty of Medicine, Department of Clinical Microbiology, Section of Virology.ORCID iD: 0000-0001-5109-9408
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2022 (English)In: European Urology, ISSN 0302-2838, E-ISSN 1873-7560, Vol. 81, no 3, p. 285-293Article in journal (Refereed) Published
Abstract [en]

Background: Men are more severely affected by COVID-19. Testosterone may influence SARS-CoV-2 infection and the immune response.

Objective: To clinically, epidemiologically, and experimentally evaluate the effect of antiandrogens on SARS-CoV-2 infection.

Designs, settings, and participants: A randomized phase 2 clinical trial (COVIDENZA) enrolled 42 hospitalized COVID-19 patients before safety evaluation. We also conducted a population-based retrospective study of 7894 SARS-CoV-2–positive prostate cancer patients and an experimental study using an air-liquid interface three-dimensional culture model of primary lung cells.

Intervention: In COVIDENZA, patients were randomized 2:1 to 5 d of enzalutamide or standard of care.

Outcome measurements: The primary outcomes in COVIDENZA were the time to mechanical ventilation or discharge from hospital. The population-based study investigated risk of hospitalization, intensive care, and death from COVID-19 after androgen inhibition.

Results and limitations: Enzalutamide-treated patients required longer hospitalization (hazard ratio [HR] for discharge from hospital 0.43, 95% confidence interval [CI] 0.20–0.93) and the trial was terminated early. In the epidemiological study, no preventive effects were observed. The frail population of patients treated with androgen deprivation therapy (ADT) in combination with abiraterone acetate or enzalutamide had a higher risk of dying from COVID-19 (HR 2.51, 95% CI 1.52–4.16). In vitro data showed no effect of enzalutamide on virus replication. The epidemiological study has limitations that include residual confounders.

Conclusions: The results do not support a therapeutic effect of enzalutamide or preventive effects of bicalutamide or ADT in COVID-19. Thus, these antiandrogens should not be used for hospitalized COVID-19 patients or as prevention for COVID-19. Further research on these therapeutics in this setting are not warranted.

Patient summary: We studied whether inhibition of testosterone could diminish COVID-19 symptoms. We found no evidence of an effect in a clinical study or in epidemiological or experimental investigations. We conclude that androgen inhibition should not be used for prevention or treatment of COVID-19.

Place, publisher, year, edition, pages
Elsevier, 2022. Vol. 81, no 3, p. 285-293
Keywords [en]
COVID-19, SARS-CoV-2, Antiandrogen, Randomized trial, Enzalutamide, Bicalutamide, Androgen deprivation therapy
National Category
Cancer and Oncology Public Health, Global Health, Social Medicine and Epidemiology Urology and Nephrology Infectious Medicine
Identifiers
URN: urn:nbn:se:umu:diva-190911DOI: 10.1016/j.eururo.2021.12.013ISI: 000809752100020Scopus ID: 2-s2.0-85122412349OAI: oai:DiVA.org:umu-190911DiVA, id: diva2:1623939
Funder
Knut and Alice Wallenberg Foundation, 2020.0182ProstatacancerförbundetSwedish Cancer Society, 2017/478Swedish Cancer Society, 20 1055 PjFSwedish Heart Lung Foundation, 20200385Region Västerbotten, RV-836351Region Västerbotten, RV-939769Available from: 2022-01-02 Created: 2022-01-02 Last updated: 2023-04-25Bibliographically approved

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Rosendal, EbbaLenman, AnnasaraFonseca Rodriguez, OsvaldoRepo, JohannaStyrke, JohanAngelin, MartinLindquist, ElisabethAllard, AnnikaBecker, MiriamRudolfsson, Stina H.Buckland, RobertAhlm, ClasFors Connolly, Anne-MarieÖverby, Anna K.Josefsson, Andreas

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Rosendal, EbbaLenman, AnnasaraFonseca Rodriguez, OsvaldoRepo, JohannaStyrke, JohanAngelin, MartinLindquist, ElisabethAllard, AnnikaBecker, MiriamRudolfsson, Stina H.Buckland, RobertAhlm, ClasFors Connolly, Anne-MarieÖverby, Anna K.Josefsson, Andreas
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Section of VirologyMolecular Infection Medicine Sweden (MIMS)Department of Clinical MicrobiologyUrology and AndrologyWallenberg Centre for Molecular Medicine at Umeå University (WCMM)
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Cancer and OncologyPublic Health, Global Health, Social Medicine and EpidemiologyUrology and NephrologyInfectious Medicine

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