Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04509999
• Other study ID #: IRB202001669-A
• Secondary ID: OCR38162
• Status: Withdrawn
• Phase: Phase 3
• Start date: October 26, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Infection

Intervention

Drug:
• Bicalutamide 150 Mg Oral Tablet
Bicalutamide 150 mg by mouth daily
• Placebo
Placebo as formulated by mouth daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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