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)

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.

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