Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-30 @ 10:10 AM
Study NCT ID:
NCT06255860
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2024-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk / World Health Organization (WHO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2024-02-07', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of MIS-C cases occurred after first SARS-CoV-2 infection', 'timeFrame': '8 months', 'description': 'Assessment of risk of MIS-C after first SARS-CoV-2 infection'}, {'measure': 'proportion of MIS-C cases occurred after SARS-CoV-2 reinfection', 'timeFrame': '8 months', 'description': 'Assessment of risk of MIS-C after SARS-CoV-2 reinfection'}, {'measure': 'Proportion of SARS-CoV-2 reinfection after first SARS-CoV-2 infection', 'timeFrame': '8 months', 'description': 'Assessment of risk of SARS-CoV-2 reinfection after first SARS-CoV-2 infection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sars-CoV-2 Infection', 'MIS-C']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, international, non interventional, retrospective study about SARS-CoV-2 and Multisystem Inflammatory Syndrome (MIS-C) reinfection risk in children.', 'detailedDescription': 'This study is based to data collection of cases (patients with MIS-C) compare to controls (patients with SARS-CoV-2 infection) occurring between 01 sep 2021 and 30 apr 2022. For this study cases and controls group will be matched for analyses.\n\nThe main of this study is to evaluate the difference of risk of occurrence of MIS-C between a first SARS-CoV-2 infection and a reinfection with SARS-CoV-2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children with SARS-CoV-2 and children with MIS-C between the 01 sep 2021 and 30 apr 2022 period', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\ngroup 1: cases\n\n* Patients with MIS-C (following SARS CoV-2 infection)\n* Hospitalised between the 01 sep 2021 and 30 apr 2022\n* Under 18 years of age\n* Not vaccinated for SARS-CoV-2\n\ngroup 2: controls\n\n* Patients not hospitalised, treated by outpatient care\n* With documented SARS-CoV-2 infection between the 01 sep 2021 and 30 apr 2022\n* Matched with a case on age (+/- 6 months), gender and country\n* Not vaccinated for SARS-CoV-2\n\nExclusion Criteria:\n\n\\- Refusal to participate by patient relative or legal representative'}, 'identificationModule': {'nctId': 'NCT06255860', 'acronym': 'REPI', 'briefTitle': 'COVID-19 and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk / World Health Organization (WHO)', 'organization': {'class': 'OTHER', 'fullName': 'Association Clinique Thérapeutique Infantile du val de Marne'}, 'officialTitle': 'SARS-COV-2 (virus Responsible of COVID-19) Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study', 'orgStudyIdInfo': {'id': 'REPI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'children with MIS-C', 'description': 'hospitalized children with MIS-C'}, {'label': 'SARS-CoV-2 infection', 'description': 'non hospitalized children infected with SARS-CoV-2 treated by outpatient care'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'ACTIV', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': 'Corinne Levy, Physician', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Association Clinique Thérapeutique Infantile du val de Marne'}, {'name': 'Naim Ouldali, Physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Robert Debré AP-HP, Paris 19'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Clinique Thérapeutique Infantile du val de Marne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}