COMBO: Camostat With Bicalutamide for COVID-19

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)

Overall Status

Terminated

CT.gov ID

NCT04652765

Collaborator

(none)

Enrollment

Location

Arms

7.4

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Covid19 SARS-CoV Infection Coronavirus Infection	Drug: Camostat Mesilate Drug: Bicalutamide 150 mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

COMBO Trial: Camostat With Bicalutamide for COVID-19

Actual Study Start Date :

Feb 3, 2021

Actual Primary Completion Date :

Sep 15, 2021

Actual Study Completion Date :

Sep 15, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of participants requiring hospitalization [up to 28 days]
Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28

Secondary Outcome Measures

Number of participants experiencing symptoms [up to 21 days]
Number of drug-related adverse events [up to 60 days]
Number of adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)
Number of drug-related serious adverse events [up to 60 days]
Number of serious adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)
All-cause mortality [up to 60 days]
Number of participants deceased.

Other Outcome Measures

Duration of hospitalization [up to 60 days]
Number of calendar days in the hospital
Number of participants requiring upgrade to intermediate care unit (IMC) [up to 60 days]
Duration of IMC stay [up to 60 days]
Number of calendar days in IMC unit
Number of participants requiring upgrade to intensive care unit (ICU) [up to 60 days]
Duration of ICU stay [up to 60 days]
Number of calendar days in ICU
Number of participants requiring mechanical ventilation [up to 60 days]
Duration on mechanical ventilation [up to 60 days]
Number of calendar days requiring mechanical ventilation

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)