Camostat With Bicalutamide for COVID-19 (COMBO)

COMBO Trial: Camostat With Bicalutamide for COVID-19

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).

Study Overview

• Status: Terminated
• Conditions: Coronavirus Infection; Covid19; SARS-CoV Infection
• Intervention / Treatment: Drug: Camostat Mesilate; Drug: Bicalutamide 150 mg

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• >= 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care (SOC); SARS-CoV-2 positive participants will receive SOC therapy alone.
Active Comparator: SOC plus camostat and bicalutamide; SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.	Drug: Camostat Mesilate; Camostat 600mg by mouth four times a day, for a total of 7 days; Other Names: camostat; Drug: Bicalutamide 150 mg; Bicalutamide 150mg by mouth once daily, for a total of 7 days
Active Comparator: SOC plus camostat; SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.	Drug: Camostat Mesilate; Camostat 600mg by mouth four times a day, for a total of 7 days; Other Names: camostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Requiring Hospitalization	Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Symptoms		up to 21 days
Number of Drug-related Adverse Events	Number of adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)	up to 60 days
Number of Drug-related Serious Adverse Events	Number of serious adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)	up to 60 days
All-cause Mortality	Number of participants deceased.	up to 60 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Hospitalization	Number of calendar days in the hospital	up to 60 days
Number of Participants Requiring Upgrade to Intermediate Care Unit (IMC)		up to 60 days
Duration of IMC Stay	Number of calendar days in IMC unit	up to 60 days
Number of Participants Requiring Upgrade to Intensive Care Unit (ICU)		up to 60 days
Duration of ICU Stay	Number of calendar days in ICU	up to 60 days
Number of Participants Requiring Mechanical Ventilation		up to 60 days
Duration on Mechanical Ventilation	Number of calendar days requiring mechanical ventilation	up to 60 days

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Principal Investigator: Catherine H Marshall, MD/MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19; bicalutamide; SARS-COV-2; Camostat; TMPRSS2
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Severe Acute Respiratory Syndrome; COVID-19; Coronavirus Infections; Infections; Communicable Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Hormone Antagonists; Serine Proteinase Inhibitors; Trypsin Inhibitors; Androgen Antagonists; Bicalutamide; Camostat
• Other Study ID Numbers: COV2005; IRB00254142 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No