Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19

Severe Acute Respiratory Syndrome Clinical Trial

— RECOVER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04470544
• Other study ID #: CAM20CV
• Status: Recruiting
• Phase: Phase 2
• Start date: July 28, 2020
• Est. completion date: September 15, 2022

Study information

• Verified date: January 2021
• Source: Academic and Community Cancer Research United
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Camostat Mesilate
Given PO

Other:
• Standard of Care
At Investigator discretion

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Arizona	Scottsdale	Arizona
United States	Tucson Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Alan Bryce

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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