Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

University of Florida

Status and phase: Withdrawn; Phase 3

Conditions: COVID-19

Treatments: Drug: Bicalutamide 150 Mg Oral Tablet; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04509999

OCR38162 (Other Identifier)

IRB202001669-A

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups, including a placebo group

Standard of care and Experimental treatment of Bicalutamide

Experimental group

Description:

Each subject will be administered bicalutamide 150 mg daily at 1:1 randomization for up to 4 weeks.

Treatment:

Drug: Bicalutamide 150 Mg Oral Tablet

Standard of Care and Placebo

Placebo Comparator group

Description:

Each subject will be administered placebo as formulated at 1:1 randomization for up to 4 weeks.

Treatment:

Drug: Placebo