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Withdrawn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
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
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
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
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
No
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
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.
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
No
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
No
Learn more about this trial
Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection
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