The DAWN Antivirals Trial for Ambulatory COVID-19 Patients

Covid19 Clinical Trial

— DAWN  

Official title:

The DAWN Antivirals Trial: the Efficacy of Antivirals for COVID-19 Infections Presenting to Ambulatory Care: a Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04730206
• Other study ID #: S64445
• Status: Terminated
• Phase: Phase 3
• Start date: June 15, 2021
• Est. completion date: July 13, 2022

Study information

• Verified date: September 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: July 13, 2022
• Est. primary completion date: July 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Camostat
100 milligram tablets
• Placebo
oral tablets, identical in size and shape
• Molnupiravir
200 milligram tablets

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (5)

Lead Sponsor	Collaborator
KU Leuven	Université de Liège, Universiteit Antwerpen, University Ghent, Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

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