Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infe... | NCT04509999

Studies
Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

NCT04509999

Sponsor

University of Florida

Status

Withdrawn

Last Update Posted

Jul 1, 2021Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

COVID-19

Interventions

Bicalutamide 150 Mg Oral Tablet
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
OCR38162	Other Identifier	UF OnCore

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients enrolled and funding withdrawn

Expanded Access Info

Start Date

Oct 26, 2020Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Aug 7, 2020

First Submission Date that Met QC Criteria

Aug 11, 2020

First Posted Date

Aug 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2021

Last Update Posted Date

Jul 1, 2021Actual

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of care and Experimental treatment of Bicalutamide	Experimental	Each subject will be administered bicalutamide 150 mg daily at 1:1 randomization for up to 4 weeks.	Drug: Bicalutamide 150 Mg Oral Tablet
Standard of Care and Placebo	Placebo Comparator	Each subject will be administered placebo as formulated at 1:1 randomization for up to 4 weeks.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bicalutamide 150 Mg Oral Tablet	Drug	Bicalutamide 150 mg by mouth daily	Standard of care and Experimental treatment of Bicalutamide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender 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.

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections