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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
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
Johns Hopkins Hospital
Baltimore, Maryland, United States
Number of Participants Requiring Hospitalization
Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28
Time frame: up to 28 days
Number of Participants Experiencing Symptoms
Time frame: 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)
Time frame: 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)
Time frame: up to 60 days
All-cause Mortality
Number of participants deceased.
Time frame: up to 60 days
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