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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Recruitment Status : Withdrawn (No patients enrolled and funding withdrawn)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
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE August 7, 2020
First Posted Date  ICMJE August 12, 2020
Last Update Posted Date July 1, 2021
Actual Study Start Date  ICMJE October 26, 2020
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection
Official Title  ICMJE Randomized Trial of Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Bicalutamide 150 Mg Oral Tablet
    Bicalutamide 150 mg by mouth daily
  • Drug: Placebo
    Placebo as formulated by mouth daily
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Bicalutamide 150 Mg Oral Tablet
  • Placebo Comparator: Standard of Care and Placebo
    Each subject will be administered placebo as formulated at 1:1 randomization for up to 4 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 30, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 11, 2020)
100
Actual Study Completion Date  ICMJE June 30, 2021
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: 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.
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT04509999
Other Study ID Numbers  ICMJE IRB202001669-A
OCR38162 ( Other Identifier: UF OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frederic Kaye, MD University of Florida
PRS Account University of Florida
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP