Study Stopped
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Enzalutamide Treatment in COVID-19
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)
1 other identifier
interventional
42
1 country
6
Brief Summary
COVID-19 is a disease with high rate of morbidity if symptomatic. There is a great need of treatments to decrease the severity. The vast majority of patients needing intensive care are men, and this may be due to the androgens, either by regulation of TMPRSS2, necessary for virus internalization, or other mechanisms. Enzalutamide is an antiandrogen inhibiting the expression of androgen regulated proteins, such as TMPRSS2. The aim of this trial is to evaluate a possible beneficial effect of short-term enzalutamide treatment of COVID-19 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 covid19
Started Jul 2020
Typical duration for phase_2 covid19
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2020
CompletedStudy Start
First participant enrolled
July 15, 2020
CompletedFirst Posted
Study publicly available on registry
July 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2021
CompletedJune 2, 2022
August 1, 2021
8 months
June 8, 2020
May 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to worsening of disease
Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale
Up to 30 days after inclusion
Time to improvement of disease
Time to discharge from hospital assessed by the 7-point ordinal scale
Up to 30 days after inclusion
Secondary Outcomes (16)
Adverse events
Up to 6 months
Duration of supplemental oxygen (days)
Up to 30 days
Admission to ICU
Up to 30 days and up to 6 months
Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6
Up to 30 days
Virus load assessment day 0, 2, 4 and 6
UP to 7 days
- +11 more secondary outcomes
Study Arms (2)
Enzalutamide+Standard of Care
EXPERIMENTALUp to 5 days with 4x40 mg enzalutamide tablets orally once daily
Standard of Care
NO INTERVENTIONStandard of care
Interventions
The once daily dose will be given only during hospitalization and stop if starting invasive mechanical ventilation or at discharge from hospital
Eligibility Criteria
You may qualify if:
- Positive COVID-19 test
- Mild to severe symptoms of COVID-19
- Hospitalization
- WHO performance status 0-3
- Age above or equal to 50 years
- Can understand all the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
- Estimated expected survival of 1 year (excluding symptoms due to COVID-19)
You may not qualify if:
- Severe allergy to Enzalutamide
- Pregnant or breast-feeding women
- Need of immediate mechanical ventilation
- Current medication includes enzalutamide treatment
- Stroke or Transitory Ischemic attack in medical history
- Treatment for HIV
- Treatment with tamoxifen
- Treatment with immunosuppressive agents
- Severe immunosuppressive disease
- Treatment with warfarin or NOAC (Non-vitamin K-antagonist anticoagulants)
- Previous seizure in medical history
- Other serious illness or medical condition
- Unstable cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andreas Josefssonlead
- Umeå Universitycollaborator
- Sahlgrenska University Hospitalcollaborator
- University Hospital, Umeåcollaborator
- Uppsala University Hospitalcollaborator
- Skane University Hospitalcollaborator
- Jonkoping County Hospitalcollaborator
- Sundsvall Hospitalcollaborator
- Helsingborgs Hospitalcollaborator
- Göteborg Universitycollaborator
- Astellas Pharma Europe Ltd.collaborator
- Norrlands University Hospitalcollaborator
Study Sites (6)
Anders Bjartell
Malmo, Skåne County, Sweden
Ryhovs Hospital
Jönköping, Småland, Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Linköping University Hospital
Linköping, Sweden
Sundsvall Region Hosptial
Sundsvall, Sweden
Umeå Univerisity Hospital
Umeå, Sweden
Related Publications (1)
Welen K, Overby AK, Ahlm C, Freyhult E, Robinsson D, Henningsson AJ, Stranne J, Bremell D, Angelin M, Lindquist E, Buckland R, Carlsson CT, Pauksens K, Bill-Axelsson A, Akre O, Ryden C, Wagenius M, Bjartell A, Nilsson AC, Styrke J, Repo J, Balkhed AO, Niward K, Gisslen M, Josefsson A. 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. Trials. 2021 Mar 16;22(1):209. doi: 10.1186/s13063-021-05137-4.
PMID: 33726804DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Josefsson, MdPhD
Norrlands University Hospital, Region Västerbotten
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor and Consultant Urologist
Study Record Dates
First Submitted
June 8, 2020
First Posted
July 17, 2020
Study Start
July 15, 2020
Primary Completion
March 24, 2021
Study Completion
May 29, 2021
Last Updated
June 2, 2022
Record last verified: 2021-08