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

Primary Purpose

Severe Acute Respiratory Syndrome

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Camostat Mesilate
Standard of Care
Sponsored by
Alan Bryce
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Acute Respiratory Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in ArizonaRecruiting
  • Tucson Medical CenterRecruiting
  • Mayo Clinic in FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo + Standard of Care

Camostat + Standard of Care

Arm Description

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.

Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 9, 2020
Last Updated
January 7, 2021
Sponsor
Alan Bryce
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1. Study Identification

Unique Protocol Identification Number
NCT04470544
Brief Title
Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19
Acronym
RECOVER
Official Title
RECOVER: Phase 2 Randomized, Double-Blind Trial TREating Hospitalized Patients With COVID-19 With Camostat MesilatE, a TMPRSS2 Inhibitor
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
September 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alan Bryce

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Respiratory Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo + Standard of Care
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Camostat + Standard of Care
Arm Type
Experimental
Arm Description
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
Intervention Type
Drug
Intervention Name(s)
Camostat Mesilate
Other Intervention Name(s)
Foipan
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
At Investigator discretion
Primary Outcome Measure Information:
Title
Change in the proportion of patients alive and free from respiratory failure
Description
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.
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Change in the proportion of patients alive and free of ventilator use or ECMO
Description
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.
Time Frame
28 Days
Title
Mortality Rate
Description
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.
Time Frame
28 and 56 Days
Title
Clinical Change
Description
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.
Time Frame
14 and 28 Days
Title
Adverse Events
Description
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.
Time Frame
up to 56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan H Bryce, M.D.
Organizational Affiliation
Academic and Community Cancer Research United
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vy Nguyen
Phone
480-342-1328
Email
Nguyen.Vy@mayo.edu
First Name & Middle Initial & Last Name & Degree
Alan H Bryce, M.D.
Facility Name
Tucson Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Elias Calles
Phone
520-324-5512
Email
ClinicalResearch@tmcaz.com
First Name & Middle Initial & Last Name & Degree
Robert Aaronson
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torsak Vimoktayon
Phone
904-953-3238
Email
Vimoktayon.Torsak@mayo.edu
First Name & Middle Initial & Last Name & Degree
Stacey Pecenka
Phone
904-953-4261
Email
Pecenka.Stacey@mayo.edu
First Name & Middle Initial & Last Name & Degree
Sadia Shah, MD

12. IPD Sharing Statement

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Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19

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