The DAWN Antivirals Trial for Ambulatory COVID-19 Patients

Phase 3

Terminated

• Conditions: Covid19; SARS-CoV Infection
• Interventions: Drug: Placebo; Drug: Camostat; Drug: Molnupiravir

• Registration Number: NCT04730206
• Lead Sponsor: KU Leuven

Brief Summary

This is a prospective, placebo controlled, individually randomized controlled phase III trial in Primary Care, assessing the efficacy of antivirals, i.e. camostat and molnupiravir, in accelerating recovery in Covid-19 patients.

Detailed Description

In patients aged 40 years and above and diagnosed with Covid-19 upon study entry, we will evaluate the efficacy of camostat or molnupiravir on recovery within 30 days after randomisation. Participants will be randomly assigned to camostat, molnupiravir or placebo using a computer generated randomisation process. Participants will be treated for 7 days in case of camostat and 5 days in case of molnupiravir, and follow-up will be 30 days.

Study Timeline

• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-01-29
• Study Start: 2021-06-15
• Primary Completion: 2022-07-13
• Study Completion: 2022-07-13
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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;
• Breastfeeding;
• Known severe neurological disorder, especially seizures in the last 12 months;
• Known allergy to camostat or molnupiravir;
• Previous adverse reaction to, or currently taking, camostat or molnupiravir;
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	4 x per day for 7 days
Camostat	Camostat	4 x 200 milligram per day for 7 days
Molnupiravir	Molnupiravir	2 x 800 milligram per day for 5 days

Primary Outcome Measures

Name	Time	Method
Time to first self-reported recovery within 30 days after randomisation	within 30 days after randomisation

Secondary Outcome Measures

Name	Time	Method
Admission to ICU	over a period of 30 days after randomization
All-cause unplanned hospital admission for at least 24 hours	within 30 days after randomisation
All-cause mortality	within 30 days after randomisation
All-cause unplanned hospital admission for at least 24 hours or all-cause mortality within 30 days of randomization	over a period of 30 days after randomization
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
At least once ventilated	over a period of 30 days after randomization
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.

Trial Locations

Locations (1)

KU Leuven; 🇧🇪 Leuven, Belgium