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)
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.

Terminated
COVID-19
Corona Virus Infection

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

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 50 Years ~ Maximum: N/A
Countries
Sweden
Locations

Anders Bjartell
Malmö, Skåne, Sweden

Ryhovs Hospital
Jönköping, Småland, Sweden

Sahlgrenska University Hospital
Gothenburg, Sweden

Linköping University Hospital
Linköping, Sweden

Sundsvall Region Hosptial
Sundsvall, Sweden

Umeå Univerisity Hospital
Umeå, Sweden

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

Andreas Josefsson
NCT Number
Keywords
Enzalutamide
Randomized Clinical Trial
Covid-19
SARS-CoV2
MeSH Terms
COVID-19
Coronavirus Infections