Trials / Withdrawn
WithdrawnNCT04509999
Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection
Randomized Trial of Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Florida · Academic / Other
- Sex
- Male
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bicalutamide 150 Mg Oral Tablet | Bicalutamide 150 mg by mouth daily |
| DRUG | Placebo | Placebo as formulated by mouth daily |
Timeline
- Start date
- 2020-10-26
- Primary completion
- 2021-06-30
- Completion
- 2021-06-30
- First posted
- 2020-08-12
- Last updated
- 2021-07-01
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04509999. Inclusion in this directory is not an endorsement.