Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19

Study Overview
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Brief Summary
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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.

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

Conditions
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Severe Acute Respiratory Syndrome

Intervention / Treatment
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* Drug: Camostat Mesilate
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo + Standard of Care<br>Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo. | Other: Standard of Care<br>* At Investigator discretion<br>|
| Experimental: Camostat + Standard of Care<br>Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment. | Drug: Camostat Mesilate<br>* Given PO<br>* Other names: Foipan;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the proportion of patients alive and free of ventilator use or ECMO | To determine if reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with SOC treatment will change the proportion of patients alive and free of ventilator use or ECMO at Day 28 as compared to SOC treatment combined with placebo. | 28 Days | 
| Mortality Rate | To determine if the combination of Camostat mesilate combined with SOC treatment will result in a changed mortality rate at 28 and 56 days as compared to SOC treatment combined with placebo. | 28 and 56 Days | 
| Clinical Change | Clinical change will be defined as a 2 or more point decease on the WHO ordinal scale. Time to clinical improvement will be calculated as the number of days from study entry until the earliest date of clinical change. | 14 and 28 Days | 
| Adverse Events | Analyses for safety will include all participants who are randomized and received at least 1 dose of study treatment. Participants will be grouped according to the treatment to which they were randomized. | up to 56 days |