The DAWN Camostat Trial for Ambulatory COVID-19 Patients (DAWN)

• ClinicalTrials.gov Identifier: NCT04730206
• Recruitment Status: Recruiting
• First Posted: January 29, 2021
• Last Update Posted: February 21, 2022
• Sponsor: KU Leuven
• Collaborators: Universiteit Antwerpen; University Ghent; Université de Liège; Vrije Universiteit Brussel
• Information provided by (Responsible Party): Ann Van den Bruel, KU Leuven

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
Covid19; SARS-CoV Infection	Drug: Camostat; Drug: Placebo	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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1316 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The DAWN Camostat Trial: the Efficacy of Camostat for COVID-19 Infections Presenting to Ambulatory Care: a Randomized Controlled Trial
• Actual Study Start Date: June 15, 2021
• Estimated Primary Completion Date: May 2022
• Estimated Study Completion Date: May 2023

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 :

1. 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 [ Time Frame: within 30 days after randomisation ]

Secondary Outcome Measures :

1. All-cause unplanned hospital admission for at least 24 hours [ Time Frame: within 30 days after randomisation ]
2. All-cause mortality [ Time Frame: within 30 days after randomisation ]
3. Health status [ Time Frame: 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.
4. Oxygen administration in the home setting [ Time Frame: over a period of 30 days after randomization ]
   Number of patients who had oxygen at least once
5. All-cause mortality at 1 year after randomization [ Time Frame: at 1 year ]
6. Cardiovascular and thromboembolic complications [ Time Frame: within 7 days and 30 days after randomization ]
   Number of events
7. Symptom duration for each individual symptom [ Time Frame: over a period of 30 days after randomization ]
   Duration of symptoms reported by the patient in the patient diary as being present since randomisation
8. Duration of hospital admission for those admitted to hospital [ Time Frame: over a period of 30 days after randomization ]
   Length of stay
9. Health services usage [ Time Frame: over a period of 30 days after randomization ]
   Number of contacts with general practitioners, out-of-hours services, emergency department visits, specialist assessments
10. Consumption of antibiotics [ Time Frame: over a period of 30 days after randomisation ]
    Antibiotic consumption expressed in defined daily dose
11. Participants' quality of life [ Time Frame: 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
12. Time to sustained recovery within 14 days [ Time Frame: within 30 days after randomisation ]
    time from randomization to self-reported recovery within 14 days and remaining recovered until day 30 after randomisation.
13. At least once ventilated [ Time Frame: over a period of 30 days after randomization ]
14. Admission to ICU [ Time Frame: over a period of 30 days after randomization ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Belgium

KU Leuven; Recruiting

Leuven, Belgium, 3000

Contact: Ann Van den Bruel, MD PhD ann.vandenbruel@kuleuven.be

Sponsors and Collaborators

KU Leuven

Universiteit Antwerpen

University Ghent

Université de Liège

Vrije Universiteit Brussel

More Information

• Responsible Party: Ann Van den Bruel, Professor, KU Leuven
• ClinicalTrials.gov Identifier: NCT04730206
• Other Study ID Numbers: S64445
• First Posted: January 29, 2021
• Last Update Posted: February 21, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infections; COVID-19; Severe Acute Respiratory Syndrome; Respiratory Tract Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Camostat; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Trypsin Inhibitors; Serine Proteinase Inhibitors