Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19 (RECOVER)

• ClinicalTrials.gov Identifier: NCT04470544
• Recruitment Status: Unknown
• First Posted: July 14, 2020
• Last Update Posted: January 11, 2021
• Sponsor: Alan Bryce
• Information provided by (Responsible Party): Alan Bryce, Academic and Community Cancer Research United

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 (Clinical Trial)
• Estimated 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: July 28, 2020
• Estimated Primary Completion Date: September 15, 2022
• Estimated Study Completion Date: September 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 Name: Foipan

Outcome Measures

Primary Outcome Measures :

1. Change in the proportion of patients alive and free from respiratory failure [ Time Frame: 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 :

1. Change in the proportion of patients alive and free of ventilator use or ECMO [ Time Frame: 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.
2. Mortality Rate [ Time Frame: 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.
3. Clinical Change [ Time Frame: 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.
4. Adverse Events [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

United States, Arizona

Mayo Clinic in Arizona; Recruiting

Scottsdale, Arizona, United States, 85259

Contact: Vy Nguyen 480-342-1328 Nguyen.Vy@mayo.edu

Principal Investigator: Alan H Bryce, M.D.

Tucson Medical Center; Recruiting

Tucson, Arizona, United States, 85712

Contact: Natalia Elias Calles 520-324-5512 ClinicalResearch@tmcaz.com

Principal Investigator: Robert Aaronson

United States, Florida

Mayo Clinic in Florida; Recruiting

Jacksonville, Florida, United States, 32224

Contact: Torsak Vimoktayon 904-953-3238 Vimoktayon.Torsak@mayo.edu

Contact: Stacey Pecenka 904-953-4261 Pecenka.Stacey@mayo.edu

Principal Investigator: Sadia Shah, MD

Sponsors and Collaborators

Alan Bryce

Investigators

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

More Information

• Responsible Party: Alan Bryce, Principal Investigator, Academic and Community Cancer Research United
• ClinicalTrials.gov Identifier: NCT04470544
• Other Study ID Numbers: CAM20CV
• First Posted: July 14, 2020
• Last Update Posted: January 11, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Severe Acute Respiratory Syndrome; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Camostat; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Trypsin Inhibitors; Serine Proteinase Inhibitors