COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial.

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COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial.

Welen, Karin (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för urologi,Institute of Clinical Sciences, Department of Urology,Univ Gothenburg, Sahlgrenska Ctr Canc Res, Inst Clin Sci, Dept Urol,Sahlgrenska Acad, S-40530 Gothenburg, Sweden.,Department of Urology/Sahlgrenska Center for Cancer Research, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

Överby, Anna K. (författare): Umeå universitet,Umeå University,Umeå Univ, Virol Sect, Dept Clin Microbiol, Umeå, Sweden.;Umeå Univ, Mol Infect Med Sweden, Umeå, Sweden.,Molekylär Infektionsmedicin, Sverige (MIMS),Avdelningen för virologi

Ahlm, Clas, 1956- (författare): Umeå universitet,Umeå University,Umeå Univ, Sect Infect & Immunol, Dept Clin Microbiol, Umeå, Sweden.,Institutionen för klinisk mikrobiologi

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Freyhult, Eva, 1979- (författare): Uppsala universitet,Uppsala University,Cancerfarmakologi och beräkningsmedicin,Science for Life Laboratory, SciLifeLab,Uppsala Univ, Sweden,Department of Medical Sciences, National Bioinformatics Infrastructure Sweden, Science for Life Laboratory, Uppsala University, Uppsala, Sweden

Robinsson, David (författare): Jönköping County Council,Dept Urol, Jönköping, Sweden.

Jonsson Henningsson, Anna (författare): Linköpings universitet,Linköping University,Jönköping County Council,Linköping Univ, Dept Biomed & Clin Sci, Linköping, Sweden.;Region Jönköping Cty, Dept Clin Microbiol, Jönköping, Sweden.,Avdelningen för inflammation och infektion,Medicinska fakulteten,Region Östergötland, Klinisk mikrobiologi,Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

Stranne, Johan, 1970 (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för urologi,Institute of Clinical Sciences, Department of Urology,Univ Gothenburg, Sahlgrenska Ctr Canc Res, Inst Clin Sci, Dept Urol,Sahlgrenska Acad, S-40530 Gothenburg, Sweden.,Department of Urology/Sahlgrenska Center for Cancer Research, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

Bremell, Daniel (författare): University of Gothenburg,Univ Gothenburg, Sahlgrenska Acad, Inst Biomed, Dept Infect Dis, Gothenburg, Sweden.,Department of Infectious Diseases, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

Angelin, Martin (författare): Umeå universitet,Umeå University,Umeå Univ, Sect Infect & Immunol, Dept Clin Microbiol, Umeå, Sweden.,Institutionen för klinisk mikrobiologi

Lindquist, Elisabeth (författare): Umeå universitet,Umeå University,Umeå Univ, Sect Infect & Immunol, Dept Clin Microbiol, Umeå, Sweden.,Institutionen för klinisk mikrobiologi

Buckland, Robert (författare): Umeå universitet,Umeå University,Umeå Univ, Dept Surg & Perioperat Sci Urol & Androl, S-90187 Umeå, Sweden.;Umeå Univ, Wallenberg Ctr Mol Med, Umeå, Sweden.,Wallenberg centrum för molekylär medicin vid Umeå universitet (WCMM),Urologi och andrologi

Thellenberg-Karlsson, Camilla, 1972- (författare): Umeå universitet,Umeå University,Umeå Univ, Dept Radiat Sci, Oncol, Umeå, Sweden.,Onkologi

Pauksens, Karlis (författare): Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden,Univ Uppsala Hosp, Dept Infect Dis, Uppsala, Sweden.

Bill-Axelson, Anna (författare): Uppsala universitet,Uppsala University,Urologkirurgi,Uppsala Univ, Sweden,Department of Surgical Sciences, Uppsala University, Uppsala, Sweden

Akre, Olof (författare): Karolinska Institutet,Karolinska Institute,Karolinska Inst, Dept Mol Med & Surg, Stockholm, Sweden.,Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden

Ryden, Cecilia (författare): Lund University,Lunds universitet,Kliniska Vetenskaper, Helsingborg,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Clinical Sciences, Helsingborg,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Lund Univ, Dept Clin Sci, Div Infect Med, Lund, Sweden.,Division of Infection Medicine, Department of Clinical Sciences, Lund University, Lund, Sweden

Wagenius, Magnus (författare): Lund University,Lunds universitet,Infektionsmedicin,Sektion III,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Infection Medicine (BMC),Section III,Department of Clinical Sciences, Lund,Faculty of Medicine,Lund Univ, Dept Translat Med, Div Urol Canc, Malmö, Sweden.,Division of Urological Cancers, Department of Translational Medicine, Lund University, Malmö, Sweden

Bjartell, Anders (författare): Lund University,Lunds universitet,Urologisk cancerforskning, Malmö,Forskargrupper vid Lunds universitet,Urological cancer, Malmö,Lund University Research Groups,Lund Univ, Dept Translat Med, Div Urol Canc, Malmö, Sweden.,Division of Urological Cancers, Department of Translational Medicine, Lund University, Malmö, Sweden

Nilsson, Anna C. (författare): Lund University,Lunds universitet,Klinisk infektionsmedicin,Forskargrupper vid Lunds universitet,Clinical infection medicine,Lund University Research Groups,Lund Univ, Infect Dis Res Unit, Dept Translat Med, Malmö, Sweden.,Department of Translational Medicine, Infectious Diseases Research Unit, Lund University, Malmö, Sweden

Styrke, Johan (författare): Umeå universitet,Umeå University,Umeå Univ, Dept Surg & Perioperat Sci Urol & Androl, S-90187 Umeå, Sweden.,Urologi och andrologi

Repo, Johanna (författare): Umeå universitet,Umeå University,Umeå Univ, Sect Infect & Immunol, Dept Clin Microbiol, Umeå, Sweden.,Institutionen för klinisk mikrobiologi

Balkhed Östholm, Åse (författare): Jönköping County Council,Region Jönköping Cty, Dept Clin Microbiol, Jönköping, Sweden.

Niward, Katarina (författare): Jönköping County Council,Region Jönköping Cty, Dept Clin Microbiol, Jönköping, Sweden.

Gisslén, Magnus, 1962 (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för infektionssjukdomar,Institute of Biomedicine, Department of Infectious Medicine,Department of Infectious Diseases, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Infectious Diseases, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden,Univ Gothenburg, Sahlgrenska Acad, Inst Biomed, Dept Infect Dis, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Infect Dis, Gothenburg, Sweden.

Josefsson, Andreas, 1979 (författare): Umeå universitet,Umeå University,University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för urologi,Institute of Clinical Sciences, Department of Urology,Univ Gothenburg, Sahlgrenska Ctr Canc Res, Inst Clin Sci, Dept Urol,Sahlgrenska Acad, S-40530 Gothenburg, Sweden.;Umeå Univ, Dept Surg & Perioperat Sci Urol & Androl, S-90187 Umeå, Sweden.;Umeå Univ, Wallenberg Ctr Mol Med, Umeå, Sweden.,Wallenberg centrum för molekylär medicin vid Umeå universitet (WCMM),Urologi och andrologi

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2021-03-16
2021
Engelska.
Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 22:1

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Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

Stäng

The main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization.Hospitalised COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority.Included participants, men or women above 50 years of age, must be hospitalised for PCR confirmed COVID-19 symptoms and not in need of immediate mechanical ventilation. Major exclusion criteria are breast-feeding or pregnant women, hormonal treatment for prostate or breast cancer, treatment with immunosuppressive drugs, current symptomatic unstable cardiovascular disease (see Additional file 1 for further details). The trial is registered at Umeå University Hospital, Region Västerbotten, Sweden and 8 hospitals are approved for inclusion in Sweden.Patients randomised to the treatment arm will be treated orally with 160 mg (4x40 mg) enzalutamide (Xtandi®) daily, for five consecutive days. The study is not placebo controlled. The comparator is standard of care treatment for patients hospitalised with COVID-19.The primary endpoints of the study are (time to) need of mechanical ventilation or discharge from hospital as assessed by a clinical 7-point ordinal scale (up to 30 days after inclusion).Randomisation was stratified by center and sex. Each strata was randomized separately with block size six with a 2:1 allocation ratio (enzalutamide + "standard of care": "standard of care"). The randomisation list, with consecutive subject numbers, was generated by an independent statistician using the PROC PLAN procedure of SAS version 9.4 software (SAS Institute, Inc, Cary, North Carolina) BLINDING (MASKING): This is an open-label trial.The trial is designed to have three phases. The first, an exploration phase of 45 participants (30 treatment and 15 control) will focus on safety and includes a more extensive laboratory assessment as well as more frequent safety evaluation. The second prolongation phase, includes the first 100 participants followed by an interim analysis to define the power of the study. The third phase is the continuation of the study up to maximum 600 participants included in total.The current protocol version is COVIDENZA v2.0 as of September 10, 2020. Recruitment started July 29, 2020 and is presently in safety pause after the first exploration phase. Recruitment is anticipated to be complete by 31 December 2021.Eudract number 2020-002027-10 ClinicalTrials.gov Identifier: NCT04475601 , registered June 8, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Allmänmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- General Practice (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)

Nyckelord

Antiviral Agents
adverse effects
therapeutic use
COVID-19
diagnosis
drug therapy
virology
Clinical Trials
Phase II as Topic
Female
Host-Pathogen Interactions
Humans
Male
Middle Aged
Multicenter Studies as Topic
Phenylthiohydantoin
adverse effects
analogs & derivatives
therapeutic use
Prospective Studies
Randomized Controlled Trials as Topic
SARS-CoV-2
drug effects
pathogenicity
Sweden
Time Factors
Treatment Outcome
Virus Internalization
drug effects
androgen signalling
antiandrogen
enzalutamide
multicentre
protocol
Randomised controlled trial
TMPRSS2
COVID-19

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Infektionsmedici ...

MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Allmänmedicin

MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Kardiologi

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Av lärosätet: Göteborgs universitet; Lunds universitet; Uppsala universitet; Karolinska Institutet; Linköpings universitet; Umeå universitet

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