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

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

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 Overview

• Status: Unknown
• Conditions: Severe Acute Respiratory Syndrome
• Intervention / Treatment: Other: Standard of Care; Drug: Camostat Mesilate

• Study Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Contact: Vy Nguyen; Phone Number: 480-342-1328; Email: Nguyen.Vy@mayo.edu
      • Principal Investigator: Alan H Bryce, M.D.
    • Tucson, Arizona, United States, 85712
      • Recruiting
      • Tucson Medical Center
      • Contact: Natalia Elias Calles; Phone Number: 520-324-5512; Email: ClinicalResearch@tmcaz.com
      • Principal Investigator: Robert Aaronson
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic in Florida
      • Principal Investigator: Sadia Shah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 28, 2020
• Primary Completion (ANTICIPATED): September 15, 2022
• Study Completion (ANTICIPATED): September 15, 2022

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (ACTUAL): July 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Severe Acute Respiratory Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Trypsin Inhibitors; Camostat
• Other Study ID Numbers: CAM20CV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No