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

Alan Bryce

Status and phase: Completed; Phase 2

Conditions: Severe Acute Respiratory Syndrome

Treatments: Other: Standard of Care; Drug: Camostat Mesilate

Study type: Interventional

Funder types: Other

Identifiers

NCT04470544

CAM20CV

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Placebo + Standard of Care

Placebo Comparator group

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.

Treatment:

Other: Standard of Care

Camostat + Standard of Care

Experimental group

Description:

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

Treatment:

Drug: Camostat Mesilate