Enzalutamide Treatment in COVID-19

• Status: Terminated
• Trial end date: 2021-05-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andreas Josefsson
• Collaborators: Astellas Pharma Europe Ltd.; Göteborg University; Helsingborgs Hospital; Jonkoping County Hospital; Norrlands University Hospital; Sahlgrenska University Hospital, Sweden; Skane University Hospital; Sundsvall Hospital; Umeå University; University Hospital, Umeå; Uppsala University Hospital

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