Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

NCT04509999 | Withdrawn Phase 3 DMC FDA Drug

• 2 other identifiers: IRB202001669-AOCR38162
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard of care and Experimental treatment of Bicalutamide

EXPERIMENTAL

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

Drug: Bicalutamide 150 Mg Oral Tablet

Standard of Care and Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Bicalutamide 150 Mg Oral Tablet DRUG

Bicalutamide 150 mg by mouth daily

Standard of care and Experimental treatment of Bicalutamide

Placebo DRUG

Placebo as formulated by mouth daily

Standard of Care and Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Only men \> 18 years of age are eligible for this trial testing anti-androgen agents. This medication has not been approved for use in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

COVID-19

Interventions

bicalutamide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Frederic Kaye, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 12, 2020
• Study Start: October 26, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share