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Camostat Mesylate for Ambulatory COVID-19
NCT04608266Phase 3
Key facts
- Status
- Terminated
- Start
- Dec 2020
- Primary completion
- Sep 2021
- Countries
- 1
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Small Molecules
- Drugs
- camostat mesilate
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, double-blind trial in coronavirus disease 2019 (COVID-19) comparing Camostat mesylate with Placebo (2 arms). Primary endpoint: Hospitalization for COVID-19 deterioration or death without hospitalization at Day 21. Started Dec 2020; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Camostat mesylate
Camostat mesylate, oral administration 600mg/day (2 x 100mg tablets every 8 hours) for 14 days
Placebo
Placebo tablets, oral administration 2 tablets every 8 hours for 14 days
03
Who it enrols
Adult patients (>=18 years) with laboratory-confirmed mild COVID-19 and at least one risk factor for severe disease (age >=50, obesity, diabetes, hypertension, chronic kidney/heart/lung/liver/neurological disease, immunosuppression, or cancer). Excludes patients requiring initial hospitalization or those recently vaccinated.
04
Endpoints
Primary
Hospitalization for COVID-19 deterioration or death without hospitalization
Secondary
Adverse events
Serious adverse events
Investigational medication discontinuation
Hospitalization for COVID-19 deterioration or death without hospitalization, evaluated by independent adjudication comittee
Clinical improvement using the Word Health Organization (WHO) COVID-19 scale
Need for intensive care
Duration of hospitalization
Need for invasive mechanical ventilation for severe COVID-19
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