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.