Clinical trial NCT04730206: The DAWN Antivirals Trial for Ambulatory COVID-19 Patients
Official title: The DAWN Antivirals Trial: the Efficacy of Antivirals for COVID-19 Infections Presenting to Ambulatory Care: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Covid19
SARS-CoV Infection
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: University Ghent
name: Université de Liège
name: Vrije Universiteit Brussel
First posted: 2021-01-29
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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;
* 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.

Primary outcomes:
measure: Time to first self-reported recovery within 30 days after randomisation
timeFrame: within 30 days after randomisation
Secondary outcomes:
measure: All-cause unplanned hospital admission for at least 24 hours
timeFrame: within 30 days after randomisation
measure: All-cause mortality
timeFrame: within 30 days after randomisation
measure: Health status
timeFrame: at 8 days and 30 days after randomization
measure: Oxygen administration in the home setting
timeFrame: over a period of 30 days after randomization
measure: All-cause mortality at 1 year after randomization
timeFrame: at 1 year
measure: Cardiovascular and thromboembolic complications
timeFrame: within 7 days and 30 days after randomization
measure: Symptom duration for each individual symptom
timeFrame: over a period of 30 days after randomization
measure: Duration of hospital admission for those admitted to hospital
timeFrame: over a period of 30 days after randomization
measure: Health services usage
timeFrame: over a period of 30 days after randomization
measure: Consumption of antibiotics
timeFrame: over a period of 30 days after randomisation
measure: Participants' quality of life
timeFrame: at 7 days and 30 days after randomization
measure: Time to sustained recovery within 14 days
timeFrame: within 30 days after randomisation
measure: At least once ventilated
timeFrame: over a period of 30 days after randomization
measure: Admission to ICU
timeFrame: over a period of 30 days after randomization
measure: All-cause unplanned hospital admission for at least 24 hours or all-cause mortality within 30 days of randomization
timeFrame: over a period of 30 days after randomization
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References: