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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04470544|
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : January 11, 2021
|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.
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|