Enzalutamide Treatment in COVID-19

Last updated: May 30, 2022
Sponsor: Andreas Josefsson
Overall Status: Terminated

Phase

2

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT04475601
COVIDENZA
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, andprovide authorization of use and disclosure of personal health information.
  • Estimated expected survival of 1 year (excluding symptoms due to COVID-19)

Exclusion

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

Study Design

Total Participants: 42
Study Start date:
July 15, 2020
Estimated Completion Date:
May 29, 2021

Connect with a study center

  • Anders Bjartell

    Malmö, Skåne
    Sweden

    Site Not Available

  • Ryhovs Hospital

    Jönköping, Småland
    Sweden

    Site Not Available

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Site Not Available

  • Linköping University Hospital

    Linköping,
    Sweden

    Site Not Available

  • Sundsvall Region Hosptial

    Sundsvall,
    Sweden

    Site Not Available

  • Umeå Univerisity Hospital

    Umeå,
    Sweden

    Site Not Available

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