Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Trial of Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Bicalutamide 150 Mg Oral Tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard of care and Experimental treatment of Bicalutamide<br>Each subject will be administered bicalutamide 150 mg daily at 1:1 randomization for up to 4 weeks. | Drug: Bicalutamide 150 Mg Oral Tablet<br>* Bicalutamide 150 mg by mouth daily<br>|
| Placebo Comparator: Standard of Care and Placebo<br>Each subject will be administered placebo as formulated at 1:1 randomization for up to 4 weeks. | Drug: Placebo<br>* Placebo as formulated by mouth daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion x 100 = percent of patients with improved COVID-19 symptoms | 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. | Day 28 |