Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19

NCT ID: NCT04470544

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2022-01-20

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.

Conditions

Severe Acute Respiratory Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Standard of Care

Intervention Type: OTHER

At Investigator discretion

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.

Group Type: EXPERIMENTAL

Camostat Mesilate

Intervention Type: DRUG

Given PO

Interventions

Camostat Mesilate

Given PO

Intervention Type: DRUG

Standard of Care

At Investigator discretion

Intervention Type: OTHER

Other Intervention Names

Foipan

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alan Bryce

OTHER

Sponsor Role: lead

Responsible Party

Alan Bryce

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alan H Bryce, M.D.

Role: PRINCIPAL_INVESTIGATOR

Academic and Community Cancer Research United

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Tucson Medical Center

Tucson, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CAM20CV

Identifier Type: -

Identifier Source: org_study_id