Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection
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|ClinicalTrials.gov Identifier: NCT04509999|
Recruitment Status : Withdrawn (No patients enrolled and funding withdrawn)
First Posted : August 12, 2020
Last Update Posted : July 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Bicalutamide 150 Mg Oral Tablet Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized Trial of Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection|
|Actual Study Start Date :||October 26, 2020|
|Actual Primary Completion Date :||June 30, 2021|
|Actual Study Completion Date :||June 30, 2021|
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.
Placebo as formulated by mouth daily
- Proportion x 100 = percent of patients with improved COVID-19 symptoms [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04509999
|Principal Investigator:||Frederic Kaye, MD||University of Florida|