Camostat With Bicalutamide for COVID-19

Study Overview
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Brief Summary
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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).

Official Title
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COMBO Trial: Camostat With Bicalutamide for COVID-19

Conditions
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Covid19, SARS-CoV Infection, Coronavirus Infection

Intervention / Treatment
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* Drug: Camostat Mesilate
* Drug: Bicalutamide 150 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Coronavirus, Camostat, bicalutamide, TMPRSS2, SARS-COV-2