Phase 2
Completed N=100
Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19
Severe Acute Respiratory Syndrome
Source: ClinicalTrials.gov NCT04470544 ↗
Enrolled (actual)
100
Serious AEs
6.0%
Results posted
Nov 2024
Primary outcomePrimary: Proportion of Patients Alive and Free From Respiratory Failure — .891; .884 Proportion of patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Alive and Free From Respiratory Failure |
.891; .884 | — |
| SECONDARY Proportion of Patients Alive and Free of Ventilator Use or ECMO |
.891; .883 | — |
| SECONDARY Mortality Rate |
.061; .070 | — |
| SECONDARY Clinical Change |
4; 4 | — |
| SECONDARY Adverse Event Grade 3 Plus Rate |
.17; .20 | — |
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
Data sourced from ClinicalTrials.gov (NCT04470544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.