Back to results

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

Primary Purpose

Covid19, SARS-CoV Infection

Status

Terminated

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

Camostat

Placebo

Molnupiravir

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

KU Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Camostat

Placebo

Molnupiravir

Arm Description

4 x 200 milligram per day for 7 days

4 x per day for 7 days

2 x 800 milligram per day for 5 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All-cause unplanned hospital admission for at least 24 hours

All-cause mortality

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.

Oxygen administration in the home setting

Number of patients who had oxygen at least once

All-cause mortality at 1 year after randomization

Cardiovascular and thromboembolic complications

Number of events

Symptom duration for each individual symptom

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

Length of stay

Health services usage

Number of contacts with general practitioners, out-of-hours services, emergency department visits, specialist assessments

Consumption of antibiotics

Antibiotic consumption expressed in defined daily dose

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

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.

At least once ventilated

Admission to ICU

All-cause unplanned hospital admission for at least 24 hours or all-cause mortality within 30 days of randomization

Full Information

NCT ID

NCT04730206

First Posted

January 28, 2021

Last Updated

September 29, 2022

Sponsor

KU Leuven

Collaborators

Universiteit Antwerpen, University Ghent, Université de Liège, Vrije Universiteit Brussel

1. Study Identification

Unique Protocol Identification Number

NCT04730206

Brief Title

The DAWN Antivirals Trial for Ambulatory COVID-19 Patients

Acronym

DAWN

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

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Terminated

Why Stopped

recruitment was too slow

Study Start Date

June 15, 2021 (Actual)

Primary Completion Date

July 13, 2022 (Actual)

Study Completion Date

July 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

Collaborators

Universiteit Antwerpen, University Ghent, Université de Liège, Vrije Universiteit Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, SARS-CoV Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Participants will be masked for camostat or placebo, molnupiravir is open label

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Camostat

Arm Type

Experimental

Arm Description

4 x 200 milligram per day for 7 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

4 x per day for 7 days

Arm Title

Molnupiravir

Arm Type

Experimental

Arm Description

2 x 800 milligram per day for 5 days

Intervention Type

Drug

Intervention Name(s)

Camostat

Intervention Description

100 milligram tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

oral tablets, identical in size and shape

Intervention Type

Drug

Intervention Name(s)

Molnupiravir

Intervention Description

200 milligram tablets

Primary Outcome Measure Information:

Title

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

Time Frame

within 30 days after randomisation

Secondary Outcome Measure Information:

Title

All-cause unplanned hospital admission for at least 24 hours

Time Frame

within 30 days after randomisation

Title

All-cause mortality

Time Frame

within 30 days after randomisation

Title

Health status

Description

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.

Time Frame

at 8 days and 30 days after randomization

Title

Oxygen administration in the home setting

Description

Number of patients who had oxygen at least once

Time Frame

over a period of 30 days after randomization

Title

All-cause mortality at 1 year after randomization

Time Frame

at 1 year

Title

Cardiovascular and thromboembolic complications

Description

Number of events

Time Frame

within 7 days and 30 days after randomization

Title

Symptom duration for each individual symptom

Description

Duration of symptoms reported by the patient in the patient diary as being present since randomisation

Time Frame

over a period of 30 days after randomization

Title

Duration of hospital admission for those admitted to hospital

Description

Length of stay

Time Frame

over a period of 30 days after randomization

Title

Health services usage

Description

Number of contacts with general practitioners, out-of-hours services, emergency department visits, specialist assessments

Time Frame

over a period of 30 days after randomization

Title

Consumption of antibiotics

Description

Antibiotic consumption expressed in defined daily dose

Time Frame

over a period of 30 days after randomisation

Title

Participants' quality of life

Description

Time Frame

at 7 days and 30 days after randomization

Title

Time to sustained recovery within 14 days

Description

time from randomization to self-reported recovery within 14 days and remaining recovered until day 30 after randomisation.

Time Frame

within 30 days after randomisation

Title

At least once ventilated

Time Frame

over a period of 30 days after randomization

Title

Admission to ICU

Time Frame

over a period of 30 days after randomization

Title

All-cause unplanned hospital admission for at least 24 hours or all-cause mortality within 30 days of randomization

Time Frame

over a period of 30 days after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

KU Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

The DAWN Antivirals Trial for Ambulatory COVID-19 Patients

We'll reach out to this number within 24 hrs