Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

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

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19
• Intervention / Treatment: Drug: Bicalutamide 150 Mg Oral Tablet; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Frederic Kaye, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Androgen Antagonists; Bicalutamide
• Other Study ID Numbers: IRB202001669-A; OCR38162 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes