Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19

Alan Bryce100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Severe Acute Respiratory Syndrome

Interventions

Camostat MesilateDRUG

Given PO

Standard of CareOTHER

At Investigator discretion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Tucson Medical Center

Tucson, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: 28 Days

Secondary Outcomes

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.

Time frame: 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 days as compared to SOC treatment combined with placebo.

Time frame: 28 Days

Clinical Change

Clinical change will be defined as a 2 or more point decease on the WHO ordinal scale. The WHO ordinal scale ranges from 0, the best status, to 8, death. Time to clinical improvement will be calculated as the number of days from study entry until the earliest date of clinical change.

Time frame: 28 Days

Adverse Event Grade 3 Plus Rate

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.

Time frame: 28 days

Data from ClinicalTrials.gov

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