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Enzalutamide Treatment in COVID-19 (COVIDENZA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
COVID-19 Corona Virus Infection Drug: Enzalutamide Pill Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Official Title: A Prospective, Multicenter, Randomized PHASE II Clinical Trial of Enzalutamide Treatment to Decrease the Morbidity in Patients With Corona Virus Disease 2019 (COVID-19)
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : July 8, 2021
Estimated Study Completion Date : May 8, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Enzalutamide+Standard of Care
Up to 5 days with 4x40 mg enzalutamide tablets orally once daily
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

No Intervention: Standard of Care
Standard of care



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Up to 6 months ]
    Safety evaluation, as measured by AEs

  2. Duration of supplemental oxygen (days) [ Time Frame: Up to 30 days ]
    Total days of extra oxygen

  3. Admission to ICU [ Time Frame: Up to 30 days and up to 6 months ]
    Frequence of admission to ICU

  4. Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: Hb

  5. 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

  6. Hospital stay (days) [ Time Frame: Up to30 days and 6 months ]
    Total number of days evaluated at 30 days and 6 months

  7. 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

  8. Mortality at 6 months [ Time Frame: up to 30 days and up to 6 months respectively ]
    Death due to any cause

  9. Hormonal status at 6 months [ Time Frame: from baseline to 6 months ]
    Testosterone and estrogen levels

  10. Serological immunity for COVID-19 [ Time Frame: At 6 months ]
    Identification of serologic immunity based after 6 months from inclusion

  11. Laboratory assessment of CRP concentration day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: CRP

  12. 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

  13. Laboratory assessment of creatinine concentration day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: Createnin

  14. Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: D-dimer

  15. Laboratory assessment of platelets concentration day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: TPK

  16. Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6 [ Time Frame: Up to 30 days ]
    Changes of laboratory parameters: IL-6

  17. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475601


Contacts
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Contact: Andreas Josefsson, MDPhD +46 70 3805395 andreas.josefsson@umu.se
Contact: Karin Welén, Assoc. Professor +46 706102231 karin.welen@urology.gu.se

Locations
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Sweden
Anders Bjartell Recruiting
Malmö, Skåne, Sweden
Contact: Anders Bjartell, MD/Prof         
Principal Investigator: Anders Bjartell         
Sub-Investigator: Anna Nilsson         
Ryhovs Hospital Recruiting
Jönköping, Småland, Sweden
Contact: David Robinsson, MDPhD         
Principal Investigator: David Robinsson, MDPhD         
Sub-Investigator: Anna Henningsson Jonsson, MDPhD         
Sponsors and Collaborators
Andreas Josefsson
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
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Principal Investigator: Andreas Josefsson, MdPhD Norrlands University Hospital, Region Västerbotten
Additional Information:
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Responsible Party: Andreas Josefsson, Assistant Professor and Consultant Urologist, Västerbotten County Council
ClinicalTrials.gov Identifier: NCT04475601    
Other Study ID Numbers: COVIDENZA
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
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

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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
Keywords provided by Andreas Josefsson, Västerbotten County Council:
Enzalutamide
Randomized clinical trial
COVID-19
Sars-CoV2
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases