drugset / Trial / NCT04509999

Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

NCT04509999

Phase 3 Withdrawn University of Florida
RandomizedParallel-groupDouble-blindTreatment

Summary

COVID-19 outcomes are worse in male patients. Androgen signaling, therefore, is a target for clinical exploration. TMPRSS2 is a membrane protease required for COVID pathogenesis that is regulated by androgens. Blocking TMPRSS2 with bicalutamide may reduce viral replication and improve the clinical outcome. Therefore, the study proposes to test bicalutamide at 150 mg oral daily dosing in a double-blind placebo-controlled randomized trial in male patients with early symptomatic COVID-19 disease.

Timeline

Start
2020-10-26
Primary completion
2021-06-30
Completion
2021-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bicalutamide Other / unclassified 150 mg Oral

Indications