The DAWN Camostat Trial for Ambulatory COVID-19 Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
In patients aged 40 years and above and diagnosed with Covid-19 upon study entry, we will evaluate the efficacy of camostat on hospital admission or death within 30 days after randomisation. Participants will be randomly assigned to camostat or placebo using a computer generated randomisation process. Participants will be treated for 7 days, and follow-up will be 30 days.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Camostat 4 x 200 milligram per day for 7 days |
Drug: Camostat
100 milligram tablets
|
| Placebo Comparator: Placebo 4 x per day for 7 days |
Drug: Placebo
oral tablets, identical in size and shape
|
Outcome Measures
Primary Outcome Measures
- Co-primary outcome, 1. time to first self-reported recovery within 30 days after randomisation, 2. All-cause unplanned hospital admission for at least 24 hours or death [within 30 days after randomisation]
Secondary Outcome Measures
- All-cause unplanned hospital admission for at least 24 hours [within 30 days after randomisation]
- All-cause mortality [within 30 days after randomisation]
- Health status [at 8 days and 30 days after randomization]
Score on the World Health Organisation (WHO) clinical progression scale: measure of illness severity across a range from 0 (not infected) to 10 (dead) where lower scores indicate a better outcome.
- Oxygen administration in the home setting [over a period of 30 days after randomization]
Number of patients who had oxygen at least once
- All-cause mortality at 1 year after randomization [at 1 year]
- Cardiovascular and thromboembolic complications [within 7 days and 30 days after randomization]
Number of events
- Symptom duration for each individual symptom [over a period of 30 days after randomization]
Duration of symptoms reported by the patient in the patient diary as being present since randomisation
- Duration of hospital admission for those admitted to hospital [over a period of 30 days after randomization]
Length of stay
- Health services usage [over a period of 30 days after randomization]
Number of contacts with general practitioners, out-of-hours services, emergency department visits, specialist assessments
- Consumption of antibiotics [over a period of 30 days after randomisation]
Antibiotic consumption expressed in defined daily dose
- Participants' quality of life [at 7 days and 30 days after randomization]
Euroqol EQ-5D-5L: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate a better outcome
- Time to sustained recovery within 14 days [within 30 days after randomisation]
time from randomization to self-reported recovery within 14 days and remaining recovered until day 30 after randomisation.
- At least once ventilated [over a period of 30 days after randomization]
- Admission to ICU [over a period of 30 days after randomization]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged 40 years or older;
-
At least 2 Covid-19 suggestive symptoms at the time of inclusion, 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 PCR test or rapid Ag test in the 7 days before inclusion or at the time of inclusion;
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | KU Leuven | Leuven | Belgium | 3000 |
Sponsors and Collaborators
- KU Leuven
- Universiteit Antwerpen
- University Ghent
- Université de Liège
- Vrije Universiteit Brussel
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S64445