RECOVER: Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19

Sponsor

Alan Bryce (Other)

Overall Status

Recruiting

CT.gov ID

NCT04470544

Collaborator

(none)

264

Enrollment

Locations

Arms

25.6

Anticipated Duration (Months)

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Acute Respiratory Syndrome	Drug: Camostat Mesilate Other: Standard of Care	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

264 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 28, 2020

Anticipated Primary Completion Date :

Sep 15, 2022

Anticipated Study Completion Date :

Sep 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo + 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.	Other: Standard of Care At Investigator discretion
Experimental: Camostat + Standard of Care 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 Given PO Other Names: Foipan

Arm

Intervention/Treatment

Placebo Comparator: Placebo + 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.

Other: Standard of Care

At Investigator discretion

Experimental: Camostat + Standard of Care

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

Given PO

Other Names:

Foipan

Outcome Measures

Primary Outcome Measures

Change in the 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

Change in the 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 and 56 Days]
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.
Clinical Change [14 and 28 Days]
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.
Adverse Events [up to 56 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
2	Tucson Medical Center	Tucson	Arizona	United States	85712
3	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

Alan Bryce

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alan Bryce, Principal Investigator, Academic and Community Cancer Research United

ClinicalTrials.gov Identifier:

NCT04470544

Other Study ID Numbers:

CAM20CV

First Posted:

Jul 14, 2020

Last Update Posted:

Jan 11, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Severe Acute Respiratory Syndrome

Camostat

Study Results

No Results Posted as of Jan 11, 2021