Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 12:38 PM
Study NCT ID:
NCT04730206
Status:
TERMINATED
Last Update Posted:
2022-10-03
First Post:
2021-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The DAWN Antivirals Trial for Ambulatory COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C034532', 'term': 'camostat'}, {'id': 'C000656703', 'term': 'molnupiravir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be masked for camostat or placebo, molnupiravir is open label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'whyStopped': 'recruitment was too slow', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-29', 'studyFirstSubmitDate': '2021-01-28', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first self-reported recovery within 30 days after randomisation', 'timeFrame': 'within 30 days after randomisation'}], 'secondaryOutcomes': [{'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', '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.'}, {'measure': 'Oxygen administration in the home setting', 'timeFrame': 'over a period of 30 days after randomization', 'description': 'Number of patients who had oxygen at least once'}, {'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', 'description': 'Number of events'}, {'measure': 'Symptom duration for each individual symptom', 'timeFrame': 'over a period of 30 days after randomization', 'description': 'Duration of symptoms reported by the patient in the patient diary as being present since randomisation'}, {'measure': 'Duration of hospital admission for those admitted to hospital', 'timeFrame': 'over a period of 30 days after randomization', 'description': 'Length of stay'}, {'measure': 'Health services usage', 'timeFrame': 'over a period of 30 days after randomization', 'description': 'Number of contacts with general practitioners, out-of-hours services, emergency department visits, specialist assessments'}, {'measure': 'Consumption of antibiotics', 'timeFrame': 'over a period of 30 days after randomisation', 'description': 'Antibiotic consumption expressed in defined daily dose'}, {'measure': "Participants' quality of life", 'timeFrame': 'at 7 days and 30 days after randomization', 'description': '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'}, {'measure': 'Time to sustained recovery within 14 days', 'timeFrame': 'within 30 days after randomisation', 'description': 'time from randomization to self-reported recovery within 14 days and remaining recovered until day 30 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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'SARS-CoV Infection']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 40 years or older;\n* 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\n* Positive result on PCR test or rapid Ag test in the 7 days before inclusion or at the time of inclusion;\n* Patient is community dwelling;\n* Participant or their proxy is willing and able to give informed consent for participation in the trial;\n* Participant is willing to comply with all trial procedures.\n\nExclusion Criteria:\n\n* Hospital admission is required at the time of possible recruitment;\n* 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;\n* Participating in any other interventional drug clinical study before enrolment in the study;\n* Breastfeeding;\n* Known severe neurological disorder, especially seizures in the last 12 months;\n* Known allergy to camostat or molnupiravir;\n* Previous adverse reaction to, or currently taking, camostat or molnupiravir;\n* Patients in palliative care;\n* 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;\n* Judgement of the recruiting clinician deems participant ineligible."}, 'identificationModule': {'nctId': 'NCT04730206', 'acronym': 'DAWN', 'briefTitle': 'The DAWN Antivirals Trial for Ambulatory COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'The DAWN Antivirals Trial: the Efficacy of Antivirals for COVID-19 Infections Presenting to Ambulatory Care: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'S64445'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Camostat', 'description': '4 x 200 milligram per day for 7 days', 'interventionNames': ['Drug: Camostat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '4 x per day for 7 days', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Molnupiravir', 'description': '2 x 800 milligram per day for 5 days', 'interventionNames': ['Drug: Molnupiravir']}], 'interventions': [{'name': 'Camostat', 'type': 'DRUG', 'description': '100 milligram tablets', 'armGroupLabels': ['Camostat']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral tablets, identical in size and shape', 'armGroupLabels': ['Placebo']}, {'name': 'Molnupiravir', 'type': 'DRUG', 'description': '200 milligram tablets', 'armGroupLabels': ['Molnupiravir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'KU Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, {'name': 'University Ghent', 'class': 'OTHER'}, {'name': 'Université de Liège', 'class': 'OTHER'}, {'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ann Van den Bruel', 'investigatorAffiliation': 'KU Leuven'}}}}