Trial | NCT04475601  Report issue

Title

Enzalutamide Treatment in COVID-19
A Prospective, Multicenter, Randomized PHASE II Clinical Trial of Enzalutamide Treatment to Decrease the Morbidity in Patients With Corona Virus Disease 2019 (COVID-19)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    42
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.
Study Started
Jul 15
2020
Primary Completion
Mar 24
2021
Study Completion
May 29
2021
Last Update
Jun 02
2022

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

Enzalutamide+Standard of Care Experimental

Up to 5 days with 4x40 mg enzalutamide tablets orally once daily

Standard of Care No Intervention

Standard of care

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
No Results Posted