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Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

Primary Purpose

COVID-19

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Bicalutamide 150 Mg Oral Tablet

Placebo

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Standard of care and Experimental treatment of Bicalutamide

Standard of Care and Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04509999

First Posted

August 7, 2020

Last Updated

June 30, 2021

Sponsor

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT04509999

Brief Title

Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Withdrawn

Why Stopped

No patients enrolled and funding withdrawn

Study Start Date

October 26, 2020 (Actual)

Primary Completion Date

June 30, 2021 (Actual)

Study Completion Date

June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

4. Oversight

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

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of care and Experimental treatment of Bicalutamide

Arm Type

Experimental

Arm Description

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

Arm Title

Standard of Care and Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bicalutamide 150 Mg Oral Tablet

Intervention Description

Bicalutamide 150 mg by mouth daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo as formulated by mouth daily

Primary Outcome Measure Information:

Title

Proportion x 100 = percent of patients with improved COVID-19 symptoms

Description

Time Frame

Day 28

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

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.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederic Kaye, MD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

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