Overview

The DAWN Camostat Trial for Ambulatory COVID-19 Patients

Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
0
Participant gender:
All
Summary
This is a prospective, placebo controlled, individually randomized controlled phase III trial in Primary Care, assessing the efficacy of Camostat in preventing hospital admission or death in Covid-19 patients.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
KU Leuven
Collaborators:
Université de Liège
Universiteit Antwerpen
University Ghent
Vrije Universiteit Brussel
Treatments:
Camostat
Criteria
Inclusion Criteria:

- Aged 40 years or older;

- Covid-19 suggestive symptoms with onset of a maximum of 5 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 Ag test at the time of inclusion in the study;

- Patient is community dwelling;

- Participant or their proxy is willing and able to give informed consent for
participation in the trial;

- Participant is willing to comply with all trial procedures.

Exclusion Criteria:

- Hospital admission is required at the time of possible recruitment;

- Positive PCR or rapid antigen test for SARS-CoV-2 in the last 2 months other than a
test at recruitment or in the 7 days prior to recruitment;

- Participating in any other interventional drug clinical study before enrolment in the
study;

- Known severe neurological disorder, especially seizures in the last 12 months;

- Known allergy to camostat;

- Previous adverse reaction to, or currently taking, camostat;

- Patients in palliative care;

- Pregnant women or women of childbearing potential who may become pregnant during the
trial and don't agree to use any of the effective contraceptive measures lised above;

- Judgement of the recruiting clinician deems participant ineligible.