Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04509999|
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : January 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Bicalutamide 150 Mg Oral Tablet Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 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|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
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
|Contact: Elizabeth Piantadosi||904-525-3797||CTSICRV@ctsi.ufl.edu|
|United States, Florida|
|University of Florida Clinincal Research Vehicle||Recruiting|
|Gainesville, Florida, United States, 32603|
|Principal Investigator:||Frederic Kaye, MD||University of Florida|