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COVIDENZA: Enzalutamide Treatment in COVID-19

Sponsor
Andreas Josefsson (Other)
Overall Status
Terminated
CT.gov ID
NCT04475601
Collaborator
Umeå University (Other), Sahlgrenska University Hospital, Sweden (Other), University Hospital, Umeå (Other), Uppsala University Hospital (Other), Skane University Hospital (Other), Jonkoping County Hospital (Other), Sundsvall Hospital (Other), Helsingborgs Hospital (Other), Göteborg University (Other), Astellas Pharma Europe Ltd. (Industry), Norrlands University Hospital (Other)
42
Enrollment
6
Locations
2
Arms
10.4
Actual Duration (Months)
7
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Enzalutamide Pill
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, randomized (2:1), open, multicentre, clinical controlled trialProspective, 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 :
Jul 15, 2020
Actual Primary Completion Date :
Mar 24, 2021
Actual Study Completion Date :
May 29, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Time to worsening of disease [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 [Up to 30 days after inclusion]

    Time to discharge from hospital assessed by the 7-point ordinal scale

Secondary Outcome Measures

  1. Adverse events [Up to 6 months]

    Safety evaluation, as measured by AEs

  2. Duration of supplemental oxygen (days) [Up to 30 days]

    Total days of extra oxygen

  3. Admission to ICU [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 [Up to 30 days]

    Changes of laboratory parameters: Hb

  5. Virus load assessment day 0, 2, 4 and 6 [UP to 7 days]

    PCR based SARS-CoV-2 measurement from upper respiratory tract

  6. Hospital stay (days) [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 [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 [up to 30 days and up to 6 months respectively]

    Death due to any cause

  9. Laboratory assessment of CRP concentration day 0, 2, 4 and 6 [Up to 30 days]

    Changes of laboratory parameters: CRP

  10. Laboratory assessment of liver function day 0, 2, 4 and 6 [Up to 30 days]

    Changes of laboratory parameters: ALAT, ASTA and/or ALP

  11. Laboratory assessment of creatinine concentration day 0, 2, 4 and 6 [Up to 30 days]

    Changes of laboratory parameters: Createnin

  12. Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6 [Up to 30 days]

    Changes of laboratory parameters: D-dimer

  13. Laboratory assessment of platelets concentration day 0, 2, 4 and 6 [Up to 30 days]

    Changes of laboratory parameters: TPK

  14. Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6 [Up to 30 days]

    Changes of laboratory parameters: IL-6

  15. Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6 [Up to 30 days]

    Changes of laboratory parameters: Differentiate count of leucocytes

  16. Pharmacokinetic interaction of enzalutamide with steroids [Up to 30 days]

    Maximum Plasma Concentration [Cmax] of steroids in blood

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anders Bjartell Malmö Skåne Sweden
2 Ryhovs Hospital Jönköping Småland Sweden
3 Sahlgrenska University Hospital Gothenburg Sweden
4 Linköping University Hospital Linköping Sweden
5 Sundsvall Region Hosptial Sundsvall Sweden
6 Umeå Univerisity Hospital Umeå Sweden

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

  • Principal Investigator: Andreas Josefsson, MdPhD, Norrlands University Hospital, Region Västerbotten

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Andreas Josefsson, Assistant Professor and Consultant Urologist, Region Västerbotten
ClinicalTrials.gov Identifier:
NCT04475601
Other Study ID Numbers:
  • COVIDENZA
First Posted:
Jul 17, 2020
Last Update Posted:
Jun 2, 2022
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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, Assistant Professor and Consultant Urologist, Region Västerbotten
Enzalutamide
Randomized clinical trial
COVID-19
Sars-CoV2
Additional relevant MeSH terms:
COVID-19
Coronavirus Infections

Study Results

No Results Posted as of Jun 2, 2022