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

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

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

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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

Resource links provided by the National Library of Medicine


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470544


Locations
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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
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Principal Investigator: Alan H Bryce, M.D. Academic and Community Cancer Research United
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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    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Camostat
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors