Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19 (RECOVER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04470544|
Recruitment Status : Unknown
Verified January 2021 by Alan Bryce, Academic and Community Cancer Research United.
Recruitment status was: Recruiting
First Posted : July 14, 2020
Last Update Posted : January 11, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Severe Acute Respiratory Syndrome||Drug: Camostat Mesilate Other: Standard of Care||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
Other Name: Foipan
- 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.
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Women who are pregnant or breastfeeding
- Known hypersensitivity to the study drug, the metabolites or formulation excipient
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
|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|
|Principal Investigator:||Alan H Bryce, M.D.||Academic and Community Cancer Research United|
|Responsible Party:||Alan Bryce, Principal Investigator, Academic and Community Cancer Research United|
|Other Study ID Numbers:||
|First Posted:||July 14, 2020 Key Record Dates|
|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|
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors