Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

Sponsor

University of Florida (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04509999

Collaborator

(none)

Enrollment

Arms

8.1

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Bicalutamide 150 Mg Oral Tablet Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 26, 2020

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Frederic Kaye, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT04509999

Other Study ID Numbers:

IRB202001669-A
OCR38162

First Posted:

Aug 12, 2020

Last Update Posted:

Jul 1, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

COVID-19

Bicalutamide

Study Results

No Results Posted as of Jul 1, 2021