Status:
WITHDRAWN
Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection
Lead Sponsor:
University of Florida
Conditions:
COVID-19
Eligibility:
MALE
18-99 years
Phase:
PHASE3
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04509999
Start Date
October 26 2020
End Date
June 30 2021
Last Update
July 1 2021
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