drugset / Trial / NCT04456049

Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1

NCT04456049

RandomizedParallel-groupOpen-labelTreatment

Summary

High risk outpatient adult males with a confirmed SARS-CoV-2 infection will be included in the study. Patients will be randomized to receive Enzalutamide with standard of care (SOC) or SOC alone. Enzalutamide will be administered daily p.o. from Day 1 to Day 28 or until confirmed negativization of Nasopharyngeal swap (NPS) Polymerase chain reaction (PCR) (2 consecutive negative samples), whichever occurs first.

Timeline

Start
2020-08-24
Primary completion
2021-06-09
Completion
2021-06-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Enzalutamide Other / unclassified 40 mg Oral

Indications