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Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

NCT04509999 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-07-01

No results posted yet for this study

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

DRUG

Bicalutamide 150 Mg Oral Tablet

Bicalutamide 150 mg by mouth daily

DRUG

Placebo

Placebo as formulated by mouth daily

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Frederic Kaye, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04509999 on ClinicalTrials.gov