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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Recruitment Status : Withdrawn (No patients enrolled and funding withdrawn)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

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Bicalutamide 150 Mg Oral Tablet Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Placebo
Placebo as formulated by mouth daily




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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.
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Frederic Kaye, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04509999    
Other Study ID Numbers: IRB202001669-A
OCR38162 ( Other Identifier: UF OnCore )
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: July 1, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents