MedTrace Logo

The Potential of Camostat in COVID-19

NCT04625114 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2024-08-09

Study results available
· View outcomes & findings →

Summary

The investigators are conducting a pilot trial where they will study safety, efficacy and compliance in a cohort of ambulatory patients in the Ghent region with confirmed COVID-19 infection, in both an early stage of disease, defined as less than 5 days of symptoms and who at presentation do not meet any criteria for hospitalisation as well as asymptomatic individuals with a PCR CT value below 30.

The primary endpoint is to assess the efficacy of the drug in terms of change from day 0 to day 5 in respiratory (oropharyngeal swab RT-PCR) log10 viral load.

The aim of the study is to assess whether Camostat, a serine protease inhibitor available in an oral formulation has the potential to be studied as an antiviral drug in a large scale ambulatory setting to prevent transmission by decreasing viral load, to prevent symptoms after exposure (PEP) in asymptomatic individuals or to prevent disease progression in the occurrence of early symptomatology.

Conditions

  • Covid19

Interventions

DRUG

Camostat

Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1-\>D5);

DRUG

Placebo

SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1-\>D5).

DRUG

Camostat

Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D6-\>D10);

DRUG

Placebo

SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D6-\>D10).

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Steven Callens · UZ Gent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2022-07-12
Completion
2022-07-12

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04625114 on ClinicalTrials.gov