Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

Phase 3

Withdrawn

• Conditions: COVID-19
• Interventions: Drug: Placebo; Drug: Bicalutamide 150 Mg Oral Tablet

• Registration Number: NCT04509999
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-12
• Study Start: 2020-10-26
• Status Verified: 2021-06
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Subjects must meet all of the following criteria to be eligible for study participation:

• Men ≥ 36 years old diagnosed with at least one temperature elevation ≥ 100.4 F., OR new cough, OR new dyspnea AND documented COVID-19 positive by approved standard local laboratory assay
• Men ≥ 18 years but < 36 years old must exhibit EITHER new cough, OR new dyspnea AND documented COVID-19 positive by approved standard local laboratory assay.
• Access to working telephone or other form of communication such as email.
• Randomization within 7 days of COVID-positive study result. All subjects will undergo repeat COVID-19 assay on day 0 enrollment and a positive test is required to stay on study
• Written informed consent obtained from the subject and the subject agrees to comply with all study-related procedures

Exclusion Criteria

Subjects with any of the following will not be eligible for study participation:

• Randomization greater than 7 days from a positive COVID test result. All subjects will undergo repeat COVID-19 assay on day 0 enrollment and a negative test will result in a screen-fail and removal from study
• Admission to hospital at time of screening
• Inclusion in another randomized trial for COVID therapy
• Diagnosis of prostate cancer and/or treatment with anti-androgen in the past 3 months
• Current treatment with any androgen replacement products
• Prior allergic reaction or intolerance to Bicalutamide or other Androgen receptor Inhibitors
• Requirement for coumarin product or warfarin products due to potential displacement by bicalutamide
• Subject unable to take oral bicalutamide
• Known Hepatitis B or C
• Liver Cirrhosis
• AST/ALT greater than or equal to 3 X institutional ULN

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care and Placebo	Placebo	Each subject will be administered placebo as formulated at 1:1 randomization for up to 4 weeks.
Standard of care and Experimental treatment of Bicalutamide	Bicalutamide 150 Mg Oral Tablet	Each subject will be administered bicalutamide 150 mg daily at 1:1 randomization for up to 4 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion x 100 = percent of patients with improved COVID-19 symptoms	Day 28	COVID-19 symptom relief at day 28, and % of COVID-19 symptom relief and its 95% confidence interval (CI) will be calculated using the exact binomial distribution and compared using Fisher's exact test.