Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19

Phase 2

Completed

• Conditions: Severe Acute Respiratory Syndrome
• Interventions: Drug: Camostat Mesilate; Other: Standard of Care

• Registration Number: NCT04470544
• Lead Sponsor: Alan Bryce

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-14
• Study Start: 2020-07-28
• Primary Completion: 2021-12-22
• Study Completion: 2022-01-20
• Status Verified: 2024-02
• Results First Submitted: 2024-02-29
• Results First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Results First Posted: 2024-11-12
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Camostat + Standard of Care	Camostat Mesilate	Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
Placebo + Standard of Care	Standard of Care	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Alive and Free From Respiratory Failure	28 Days	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Alive and Free of Ventilator Use or ECMO	28 Days	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.
Mortality Rate	28 Days	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.
Clinical Change	28 Days	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.
Adverse Event Grade 3 Plus Rate	28 days	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.

Trial Locations

Locations (2)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Tucson Medical Center; 🇺🇸 Tucson, Arizona, United States