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Enzalutamide Treatment in COVID-19 (COVIDENZA)

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ClinicalTrials.gov Identifier: NCT04475601
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : July 17, 2020
Sponsor:
Collaborators:
Umeå University
Sahlgrenska University Hospital, Sweden
University Hospital, Umeå
Uppsala University Hospital
Skane University Hospital
Jonkoping County Hospital
Sundsvall Hospital
Helsingborgs Hospital
Göteborg University
Astellas Pharma Europe Ltd.
Norrlands University Hospital
Information provided by (Responsible Party):
Andreas Josefsson, Västerbotten County Council

Tracking Information
First Submitted Date  ICMJE June 8, 2020
First Posted Date  ICMJE July 17, 2020
Last Update Posted Date July 17, 2020
Actual Study Start Date  ICMJE July 15, 2020
Estimated Primary Completion Date July 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2020)
  • Time to worsening of disease [ Time Frame: Up to 30 days after inclusion ]
    Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale
  • Time to improvement of disease [ Time Frame: Up to 30 days after inclusion ]
    Time to discharge from hospital assessed by the 7-point ordinal scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2020)
  • Adverse events [ Time Frame: Up to 6 months ]
    Safety evaluation, as measured by AEs
  • Duration of supplemental oxygen (days) [ Time Frame: Up to 30 days ]
    Total days of extra oxygen
  • Admission to ICU [ Time Frame: Up to 30 days and up to 6 months ]
    Frequence of admission to ICU
  • Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: Hb
  • Virus load assessment day 0, 2, 4 and 6 [ Time Frame: UP to 7 days ]
    PCR based SARS-CoV-2 measurement from upper respiratory tract
  • Hospital stay (days) [ Time Frame: Up to30 days and 6 months ]
    Total number of days evaluated at 30 days and 6 months
  • Re-admission to hospital due to rebound COVID-19 [ Time Frame: Evaluated for 30 days and after 6 months ]
    If admitted to hospital due to COVID-19 disease after discharge from hospital
  • Mortality at 6 months [ Time Frame: up to 30 days and up to 6 months respectively ]
    Death due to any cause
  • Hormonal status at 6 months [ Time Frame: from baseline to 6 months ]
    Testosterone and estrogen levels
  • Serological immunity for COVID-19 [ Time Frame: At 6 months ]
    Identification of serologic immunity based after 6 months from inclusion
  • Laboratory assessment of CRP concentration day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: CRP
  • Laboratory assessment of liver function day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: ALAT, ASTA and/or ALP
  • Laboratory assessment of creatinine concentration day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: Createnin
  • Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: D-dimer
  • Laboratory assessment of platelets concentration day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: TPK
  • Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: IL-6
  • Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: Differentiate count of leucocytes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enzalutamide Treatment in COVID-19
Official Title  ICMJE A Prospective, Multicenter, Randomized PHASE II Clinical Trial of Enzalutamide Treatment to Decrease the Morbidity in Patients With Corona Virus Disease 2019 (COVID-19)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective, randomized (2:1), open, multicentre, clinical controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Corona Virus Infection
Intervention  ICMJE Drug: Enzalutamide Pill
The once daily dose will be given only during hospitalization and stop if starting invasive mechanical ventilation or at discharge from hospital
Study Arms  ICMJE
  • Experimental: Enzalutamide+Standard of Care
    Up to 5 days with 4x40 mg enzalutamide tablets orally once daily
    Intervention: Drug: Enzalutamide Pill
  • No Intervention: Standard of Care
    Standard of care
Publications * Welén K, Överby 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 ÅÖ, Niward K, Gisslén 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2020)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 8, 2022
Estimated Primary Completion Date July 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andreas Josefsson, MDPhD +46 70 3805395 andreas.josefsson@umu.se
Contact: Karin Welén, Assoc. Professor +46 706102231 karin.welen@urology.gu.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04475601
Other Study ID Numbers  ICMJE COVIDENZA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: The extent of sharing will be regulated during the trial to consider the integrity of the data according GDPR and national laws
Responsible Party Andreas Josefsson, Västerbotten County Council
Study Sponsor  ICMJE Andreas Josefsson
Collaborators  ICMJE
  • Umeå University
  • Sahlgrenska University Hospital, Sweden
  • University Hospital, Umeå
  • Uppsala University Hospital
  • Skane University Hospital
  • Jonkoping County Hospital
  • Sundsvall Hospital
  • Helsingborgs Hospital
  • Göteborg University
  • Astellas Pharma Europe Ltd.
  • Norrlands University Hospital
Investigators  ICMJE
Principal Investigator: Andreas Josefsson, MdPhD Norrlands University Hospital, Region Västerbotten
PRS Account Västerbotten County Council
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP