Camostat With Bicalutamide for COVID-19
Condition: Covid19; SARS-CoV Infection; Coronavirus Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome
Intervention: Camostat Mesilate; Bicalutamide 150 mg
Intervention description: Camostat 600mg by mouth four times a day, for a total of 7 days; Bicalutamide 150mg by mouth once daily, for a total of 7 days
Intervention MeSH terms: Bicalutamide; Camostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: COVID-19; Coronavirus; Camostat; bicalutamide; TMPRSS2; SARS-COV-2

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).
    

Eligibility criteria:

        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.