Camostat With Bicalutamide for COVID-19

Covid19 Clinical Trial

— COMBO  

Official title:

COMBO Trial: Camostat With Bicalutamide for COVID-19

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04652765
• Other study ID #: COV2005
• Secondary ID: IRB00254142
• Status: Terminated
• Phase: Phase 1
• Start date: February 3, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: October 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Covid19
• Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Camostat Mesilate
Camostat 600mg by mouth four times a day, for a total of 7 days
• Bicalutamide 150 mg
Bicalutamide 150mg by mouth once daily, for a total of 7 days

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of Hospitalization	Number of calendar days in the hospital	up to 60 days
Other	Number of Participants Requiring Upgrade to Intermediate Care Unit (IMC)		up to 60 days
Other	Duration of IMC Stay	Number of calendar days in IMC unit	up to 60 days
Other	Number of Participants Requiring Upgrade to Intensive Care Unit (ICU)		up to 60 days
Other	Duration of ICU Stay	Number of calendar days in ICU	up to 60 days
Other	Number of Participants Requiring Mechanical Ventilation		up to 60 days
Other	Duration on Mechanical Ventilation	Number of calendar days requiring mechanical ventilation	up to 60 days
Primary	Number of Participants Requiring Hospitalization	Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28	up to 28 days
Secondary	Number of Participants Experiencing Symptoms		up to 21 days
Secondary	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
Secondary	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
Secondary	All-cause Mortality	Number of participants deceased.	up to 60 days