COV201279: the efficacy of camostat for COVID-19 infections presenting to ambulatory care: a randomized controlled trial (DAWN Camostat)

Summary (French or Dutch)


With this study, we aim to find out whether camostat, a drug that has been on the market for over 30 years in Japan and other Asian countries, is effective in treating symptomatic COVID-19 patients.
Patients who are 45 or older, presenting to their GP or local primary care triage point with recent COVID-19 symptoms are eligible for the trial if COVID-19 infection is confirmed using a rapid antigen test and if they do not need hospital admission at that time. If patients consent to be included in the trial, they will be randomly assigned to either 2 x 100 mg tablets of camostat or 2 tablets of placebo, to be taken 4 times a day before food for 7 days. For these days and up to 30 days after inclusion, patients are asked to fill in a symptom diary every day. This can be done either by using a smartphone app, on the computer or on paper, whatever is most convenient for the patient.
Patients will be phoned on day 2, day 4 and day 30 by a study nurse, to ask about symptoms, side effects and any other queries the patients may have. Patients will also be visited by a study nurse on day 8.
Our two primary targets for evaluating camostat are, firstly whether it can reduce the time to self-reported recovery and whether it can reduce hospital admissions (for at least 24 hours) or death from any cause within 30 days after randomisation. 13106 patients will be included in the trial. Other outcomes include its effect on symptom recovery, severity of COVID-19 and quality of life. 

 

Trial Description
Title

The DAWN camostat trial: the efficacy of camostat for COVID-19 infections presenting to ambulatory care: a randomized controlled trial. The DAWN camostat trial for ambulatory COVID-19 patients

Participants (P)

•    Aged 45 years or older;
•    Covid-19 suggestive symptoms with onset of a maximum of 7 days prior to enrolment, and which cannot be explained by an alternative cause, and defined by the current Sciensano case definition;
•    Positive result on rapid Antigen at the time of inclusion in the study;
Patient is community dwelling;

Intervention (I)

Camostat, 200 mg four times a day, for 7 days, oral tablets

Control (C)

Placebo, four times a day, for 7 days, oral tablets

Outcome (O)

Two co-primary endpoints:
First co-primary endpoint: time to first self-reported recovery within 30 days after randomisation.
Second co-primary endpoint: aAll-cause unplanned hospital admission for at least 24 hours or all-cause mortality within 30 days after randomisation.

Trial Design

Prospective, individually randomised, placebo controlled phase III trial 

Sample Size

1,316

Trial duration

11 months from FPI to CSR primary endpoint, 23 months for 12m FU CSR

Budget

€2,590,000

Status

Open

 

Trial team

Sponsor

UZ Leuven – KU Leuven

Chief Investigator

Prof Ann Van den Bruel, MD

External Partners

KU Leuven - Academic Centre of General Practice
UZ Leuven - lung diseases and internal medicine
U Liege - Dept. medicine, research group general practice and health
UGent - Primary Care and internal medicine
UA - Primary Care
VUB - Family Medicine and Chronic Care
ZOL CTC (data management)

Number of participating sites

Approximately 125 GPs working in 5-10 triage points - 50 GP practices

Academic centre collaborating investigators

KU Leuven - Nicolas Delvaux, Jan Verbakel, Birgitte Schoenmakers 
U Liege – Laetitia Buret
UGent - An De Sutter, Stefan Heytens
UA - Samuel Coenen
VUB - Dirk Devroey
 

Documents
Protocol  
Report

CSR reporting primary endpoint 31/01/2022, reporting of 12 month FU data 31/01/2023

Publication

 

References

Clinicaltrials.gov: NCT04730206

Webpage: