Official Title
RECOVER: Phase 2 Randomized, Double-Blind Trial TREating Hospitalized Patients With COVID-19 With Camostat MesilatE, a TMPRSS2 Inhibitor
Brief Summary

To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.

Unknown status
Severe Acute Respiratory Syndrome

Drug: Camostat Mesilate

Given PO
Other Name: Foipan

Other: Standard of Care

At Investigator discretion

Eligibility Criteria

Inclusion Criteria:

- Laboratory confirmed SARS-CoV-2 infection

- Admitted to hospital for management of SARS-CoV-2

- Age ≥18

- Subject or legal representative able to give informed consent

- Ability to take all study drugs

- Respiratory status of 3 or greater on the WHO ordinal scale

- ALT or AST ≤5 x ULN

- Creatinine clearance ≥50 mL/min using the Cockroft-Gault formula

- Willingness to provide mandatory specimens for correlative research and banking

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Known hypersensitivity to the study drug, the metabolites or formulation excipient

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Mayo Clinic in Arizona
Scottsdale, Arizona, United States

Tucson Medical Center
Tucson, Arizona, United States

Mayo Clinic in Florida
Jacksonville, Florida, United States

Alan H Bryce, M.D., Principal Investigator
Academic and Community Cancer Research United

NCT Number
MeSH Terms
Severe Acute Respiratory Syndrome
Camostat