Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-27 @ 8:02 PM
Study NCT ID:
NCT04341792
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2020-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 373}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-07', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of secondary aggravation', 'timeFrame': 'an average at 30 days (- 2 days +3 days) of admission to the emergency department', 'description': 'Secondary aggravation is defined as :\n\n* a re-hospitalization or\n* aggravation in hospitalization : development or increase in oxygen dependency, hemodynamic failure, and/or respiratory, death'}], 'secondaryOutcomes': [{'measure': 'Change of standart biological parameters', 'timeFrame': 'Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department', 'description': 'the number of leukocytes, lymphocytes, neutrophil polynuclear cells, CRP, fibrinogen, and the D-dimers.'}, {'measure': 'Change of Von willebrand factor (vWF) changes over time', 'timeFrame': 'Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department'}, {'measure': 'Change of the Factor VIII (FVIII)', 'timeFrame': 'Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department'}, {'measure': 'Prevalence of positivity of COVID-19 virus measured by PCR or serology', 'timeFrame': 'an average at 30 days (- 2 days +3 days) of admission to the emergency department'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infection viral', 'biological risk factor', 'coronavirus', 'covid-19'], 'conditions': ['Infection Viral', 'Coronavirus', 'COVID-19']}, 'referencesModule': {'references': [{'pmid': '41093046', 'type': 'DERIVED', 'citation': 'Ledoult E, Guerrier T, Dubucquoi S, Figeac M, Villenet C, Daunou B, Behal H, Pokeerbux MR, Machet T, Koether V, Collet A, Launay D; Lille Covid Research network (LICORNE). Dual role of plasmablasts as immune regulators or amplifiers in COVID-19. Clin Immunol. 2025 Oct 13;281:110609. doi: 10.1016/j.clim.2025.110609. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'There is no predictive tool for patients admitted to the emergency department with a suspicion of Covid-19 that will worsen secondarily and require a heavy lifting.\n\nIn a context of saturation of the healthcare system by the pandemic at Covid-19,it is essential to identify specific, accessible prognostic markers via minimally invasive sampling with low risk of infection for personnel caregiver, for optimal allocation of resuscitation resources.\n\nThis study proposes to evaluate the biological markers of routine care known to be associated with resuscitation admission in relation to hospitalization on conventional service for the prediction of worsening of patients admitted to the emergencies for Covid-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult population presenting to the emergency department during this pandemic period with symptoms suggestive of Covid-19 infection with no other probable diagnosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical criteria for suspicion of Covid-19 in an epidemic period\n* Consultation in the emergency departement\n* Non-opposition agree\n\nExclusion Criteria:\n\n* impairment related to another identified cause than Covid-19, in particular a rapid diagnostic test flu-positive\n* Severe patient from the outset with transfer to intensive care within 12 hours of admission to the Emergency Department\n* No social security coverage (beneficiary or entitled person)\n* Poor understanding of French\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT04341792', 'acronym': 'BIOCOVU', 'briefTitle': 'Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient Admitted to Emergency Departments During an Epidemic', 'orgStudyIdInfo': {'id': '2020_33'}, 'secondaryIdInfos': [{'id': '2020-A00906-33', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Delphine Garrigue, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}