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A Phase 2 Trial of ...
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
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- Welén, Karin, 1970 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för urologi,Institute of Clinical Sciences, Department of Urology,Sahlgrenska Academy
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- Rosendal, Ebba (author)
- Umeå University,Umeå universitet,Avdelningen för virologi,Molekylär Infektionsmedicin, Sverige (MIMS),Department of Clinical Microbiology, Section of Virology, Umeå University, Umeå, Sweden; The Laboratory for Molecular Infection Medicine Sweden, Umeå, Sweden,Umeå Univ, Dept Clin Microbiol, Sect Virol, Umeå, Sweden.
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- Gisslén, Magnus, 1962 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för infektionssjukdomar,Institute of Biomedicine, Department of Infectious Medicine,Sahlgrenska Academy,Sahlgrenska University Hospital
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- Lenman, Annasara, 1983- (author)
- Umeå University,Umeå universitet,Avdelningen för virologi,Department of Clinical Microbiology, Section of Virology, Umeå University, Umeå, Sweden,Univ Gothenburg, Sahlgrenska Acad, Inst Biomed, Dept Infect Dis, Gothenburg, Sweden.
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- Freyhult, Eva (author)
- Uppsala University
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- Fonseca Rodriguez, Osvaldo, PhD, 1982- (author)
- Umeå University,Uppsala universitet,Umeå universitet,Institutionen för klinisk mikrobiologi,Department of Clinical Microbiology, Umeå University, Umeå, Sweden,Institutionen för medicinska vetenskaper
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- Bremell, Daniel, 1978 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för infektionssjukdomar,Institute of Biomedicine, Department of Infectious Medicine,Sahlgrenska Academy
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- Stranne, Johan, 1970 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för urologi,Institute of Clinical Sciences, Department of Urology,Sahlgrenska Academy
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- Östholm Balkhed, Åse, 1972- (author)
- Linköping University,Linköpings universitet,Medicinska fakulteten,Avdelningen för inflammation och infektion,Region Östergötland, Infektionskliniken i Östergötland,Linköping Univ, Dept Biomed & Clin Sci, Linköping, Sweden.
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- Niward, Katarina, 1971- (author)
- Linköping University,Linköpings universitet,Avdelningen för inflammation och infektion,Medicinska fakulteten,Region Östergötland, Infektionskliniken i Östergötland,Linköping Univ, Dept Biomed & Clin Sci, Linköping, Sweden.
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- Repo, Johanna (author)
- Umeå University,Umeå universitet,Institutionen för klinisk mikrobiologi,Department of Clinical Microbiology, Umeå University, Umeå, Sweden,Umeå Univ, Dept Clin Microbiol, Umeå, Sweden.
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- Robinsson, David (author)
- Department of Urology, Region of Jönköping, Jönköping, Sweden,Reg Jönköping, Dept Urol, Jönköping, Sweden.
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- Jonsson Henningsson, Anna, 1972- (author)
- Linköping University,Linköpings universitet,Avdelningen för inflammation och infektion,Medicinska fakulteten,Region Östergötland, Klinisk mikrobiologi,Department of Clinical Microbiology, Region Jönköping County, Jönköping, Sweden,Linköping Univ, Dept Biomed & Clin Sci, Linköping, Sweden.;Reg Jönköping Cty, Dept Clin Microbiol, Jönköping, Sweden.,Örebro University Hospital
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- Styrke, Johan (author)
- Umeå University,Umeå universitet,Urologi och andrologi,Department of Surgical and Perioperative Sciences, Urology & Andrology, Umeå University, Umeå, Sweden,Umeå Univ, Dept Surg & Perioperat Sci Urol & Androl, S-90187 Umeå, Sweden.
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- Angelin, Martin (author)
- Umeå University,Umeå universitet,Institutionen för klinisk mikrobiologi,Department of Clinical Microbiology, Umeå University, Umeå, Sweden,Umeå Univ, Dept Clin Microbiol, Umeå, Sweden.
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- Lindquist, Elisabeth (author)
- Umeå University,Umeå universitet,Institutionen för klinisk mikrobiologi,Department of Clinical Microbiology, Umeå University, Umeå, Sweden,Umeå Univ, Dept Clin Microbiol, Umeå, Sweden.
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- Allard, Annika (author)
- Umeå University,Umeå universitet,Avdelningen för virologi,Department of Clinical Microbiology, Section of Virology, Umeå University, Umeå, Sweden,Umeå Univ, Dept Clin Microbiol, Sect Virol, Umeå, Sweden.
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- Becker, Miriam (author)
- Umeå University,Umeå universitet,Avdelningen för virologi,Department of Clinical Microbiology, Section of Virology, Umeå University, Umeå, Sweden,Umeå Univ, Dept Clin Microbiol, Sect Virol, Umeå, Sweden.
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- Rudolfsson, Stina H. (author)
- Umeå University,Umeå universitet,Urologi och andrologi,Department of Surgical and Perioperative Sciences, Urology & Andrology, Umeå University, Umeå, Sweden,Umeå Univ, Dept Surg & Perioperat Sci Urol & Androl, S-90187 Umeå, Sweden.
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- Buckland, Robert (author)
- Umeå University,Umeå universitet,Urologi och andrologi,Department of Surgical and Perioperative Sciences, Urology & Andrology, Umeå University, Umeå, Sweden,Umeå Univ, Dept Surg & Perioperat Sci Urol & Androl, S-90187 Umeå, Sweden.
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- Thellenberg Carlsson, Camilla (author)
- Umeå University
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- Bjartell, Anders (author)
- Lund University,Lunds universitet,Urologisk cancerforskning, Malmö,Forskargrupper vid Lunds universitet,Urological cancer, Malmö,Lund University Research Groups
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- Nilsson, Anna C. (author)
- Lund University,Lunds universitet,Klinisk infektionsmedicin,Forskargrupper vid Lunds universitet,Clinical infection medicine,Lund University Research Groups
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- Ahlm, Clas, 1956- (author)
- Umeå University,Umeå universitet,Institutionen för klinisk mikrobiologi,Department of Clinical Microbiology, Umeå University, Umeå, Sweden,Umeå Univ, Dept Clin Microbiol, Umeå, Sweden.
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- Fors Connolly, Anne-Marie (author)
- Umeå University,Umeå universitet,Molekylär Infektionsmedicin, Sverige (MIMS),Institutionen för klinisk mikrobiologi,The Laboratory for Molecular Infection Medicine Sweden, Umeå, Sweden; Department of Clinical Microbiology, Umeå University, Umeå, Sweden,Lab Mol Infect Med Sweden, Umeå, Sweden.;Umeå Univ, Dept Clin Microbiol, Umeå, Sweden.
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- Överby, Anna K. (author)
- Umeå University,Umeå universitet,Molekylär Infektionsmedicin, Sverige (MIMS),Institutionen för klinisk mikrobiologi,The Laboratory for Molecular Infection Medicine Sweden, Umeå, Sweden; Department of Clinical Microbiology, Umeå University, Umeå, Sweden,Lab Mol Infect Med Sweden, Umeå, Sweden.;Umeå Univ, Dept Clin Microbiol, Umeå, Sweden.
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- Josefsson, Andreas, 1979- (author)
- Umeå University,Gothenburg University,Göteborgs universitet,Umeå universitet,Urologi och andrologi,Wallenberg centrum för molekylär medicin vid Umeå universitet (WCMM),Institute of Clinical Sciences, Department of Urology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Surgical and Perioperative Sciences, Urology & Andrology, Umeå University, Umeå, Sweden; Wallenberg Center for Molecular Medicine (WCMM), Umeå University, Umeå, Sweden,Univ Gothenburg, Sahlgrenska Acad, Inst Clin Sci, Dept Urol, Gothenburg, Sweden.;Umeå Univ, Dept Surg & Perioperat Sci Urol & Androl, S-90187 Umeå, Sweden.;Umeå Univ, Wallenberg Ctr Mol Med WCMM, Umeå, Sweden.,Institutionen för kliniska vetenskaper, Avdelningen för urologi,Institute of Clinical Sciences, Department of Urology
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(creator_code:org_t)
- Elsevier, 2022
- 2022
- English.
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In: European Urology. - : Elsevier. - 0302-2838 .- 1873-7560. ; 81:3, s. 285-293
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
Keyword
- COVID-19
- SARS-CoV-2
- Antiandrogen
- Randomized trial
- Enzalutamide
- Bicalutamide
- Androgen deprivation therapy
- Androgen deprivation therapy
- Antiandrogen
- Bicalutamide
- COVID-19
- Enzalutamide
- Randomized trial
- SARS-CoV-2
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- ref (subject category)
- art (subject category)
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Welén, Karin, 19 ...
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Rosendal, Ebba
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Gisslén, Magnus, ...
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Lenman, Annasara ...
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Freyhult, Eva
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Fonseca Rodrigue ...
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Bremell, Daniel, ...
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Stranne, Johan, ...
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Östholm Balkhed, ...
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Niward, Katarina ...
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Repo, Johanna
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Robinsson, David
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Jonsson Hennings ...
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Styrke, Johan
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Angelin, Martin
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Lindquist, Elisa ...
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Allard, Annika
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Becker, Miriam
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Rudolfsson, Stin ...
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Buckland, Robert
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Thellenberg Carl ...
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Bjartell, Anders
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Nilsson, Anna C.
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Ahlm, Clas, 1956 ...
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Fors Connolly, A ...
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Överby, Anna K.
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Josefsson, Andre ...
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European Urology
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Umeå University
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Linköping University
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Uppsala University
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