Camostat With Bicalutamide for COVID-19

NCT04652765 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: COV2005IRB00254142
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized, open-label study to determine if camostat+ bicalutamide decreases the proportion of people with COVID-19 who require hospitalization, compared to historical controls. Patients with symptomatic COVID-19, diagnosed as outpatients, will be randomized 1:1, stratified by gender, to treatment with standard of care alone (Arm 1) or with camostat and bicalutamide (Arm 2).

Conditions

Covid19; SARS-CoV Infection; Coronavirus Infection

Keywords

COVID-19; Coronavirus; Camostat; bicalutamide; TMPRSS2; SARS-COV-2

Outcome Measures

Primary Outcomes (1)

• Number of Participants Requiring Hospitalization

  Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28

  up to 28 days

Secondary Outcomes (4)

• Number of Participants Experiencing Symptoms

  up to 21 days

• Number of Drug-related Adverse Events

  up to 60 days

• Number of Drug-related Serious Adverse Events

  up to 60 days

• All-cause Mortality

  up to 60 days

Other Outcomes (7)

• Duration of Hospitalization

  up to 60 days

• Number of Participants Requiring Upgrade to Intermediate Care Unit (IMC)

  up to 60 days

• Duration of IMC Stay

  up to 60 days

Study Arms (3)

Standard of care (SOC)

NO INTERVENTION

SARS-CoV-2 positive participants will receive SOC therapy alone.

SOC plus camostat

ACTIVE COMPARATOR

SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.

Drug: Camostat Mesilate

SOC plus camostat and bicalutamide

ACTIVE COMPARATOR

SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.

Drug: Camostat Mesilate; Drug: Bicalutamide 150 mg

Interventions

Camostat Mesilate DRUG

Camostat 600mg by mouth four times a day, for a total of 7 days

Also known as: camostat

SOC plus camostat; SOC plus camostat and bicalutamide

Bicalutamide 150 mg DRUG

Bicalutamide 150mg by mouth once daily, for a total of 7 days

SOC plus camostat and bicalutamide

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 60 years of age
• COVID-19 infection, confirmed by polymerase chain reaction (PCR) test \<=5 days from enrollment done in the ambulatory setting
• Able to provide informed consent
• Symptom related to COVID-19. This includes: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea or other symptom recognized by the Centers for Disease Control to be a symptom of COVID-19.

You may not qualify if:

• Patients who undergo asymptomatic screening test that is positive and remain asymptomatic during the eligible time window
• Patients who have had one or more positive more than 5 days prior to enrollment but within 60 days of enrollment (ex. if a patient has a positive test 10 days prior to enrollment and then a second positive test the day referred for enrollment, that patient would be excluded. If a patient had a positive test 5 months ago, and then another positive test the day he/she was referred for enrollment, that patient would be eligible)
• Unable to take oral medication
• Male patients with female partners of reproductive potential who are unable to maintain effective contraception during the recommended time period (during treatment and for 130 days after the final dose)
• Symptoms requiring hospitalization or immediate referral to hospital
• Taking bicalutamide, any systemic hormonal therapy, or camostat within one month of study entry
• Known hypersensitivity to bicalutamide, or camostat, or its components.
• On coumadin anticoagulation (because of drug-drug interaction with bicalutamide)
• Self-reported past medical history of chronic liver disease or cirrhosis
• Self-reported myocardial infarction within 6 months or past medical history of congestive heart failure with known ejection fraction \< 40%
• Taking any other investigational treatment for COVID-19 or COVID-19 prophylaxis (COVID-19 vaccines and treatments allowed under FDA Emergency Use Authorization are allowed.)
• Women and people from all ethnic and race groups are eligible for this study.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Coronavirus Infections

Interventions

camostat; bicalutamide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Cathy Handy Marshall
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

chm@jhmi.edu

4109550231

Study Officials

• Catherine H Marshall, MD/MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 3, 2020
• Study Start: February 3, 2021
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: October 6, 2023
• Results First Posted: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)