Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
Study NCT ID:
NCT04420468
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2020-06-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2020-06-05', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute myocarditis', 'timeFrame': '7 days', 'description': 'Occurrence, description and time course of acute myocarditis'}, {'measure': 'Multi-systemic inflammatory syndrome', 'timeFrame': '7 days', 'description': 'Occurrence, description and time course of multi-systemic inflammatory syndrome, features of Kawasaki disease'}, {'measure': 'Kawasaki disease', 'timeFrame': '7 days', 'description': 'Occurrence, description and time course of features of Kawasaki disease'}], 'secondaryOutcomes': [{'measure': 'Results of SARS-CoV-2', 'timeFrame': '7 days', 'description': 'Results of SARS-CoV-2 screening either by PCR or antibodies serological assay'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Acute myocarditis', 'Children'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '35501302', 'type': 'BACKGROUND', 'citation': 'McCafferty C, Cai T, Borgel D, Lasne D, Renolleau S, Vedrenne-Cloquet M, Bonnet D, Wu J, Zaw T, Bhatnagar A, Song X, Van Den Helm S, Letunica N, Attard C, Karlaftis V, Praporski S, Ignjatovic V, Monagle P. Pathophysiological pathway differences in children who present with COVID-19 ARDS compared to COVID -19 induced MIS-C. Nat Commun. 2022 May 2;13(1):2391. doi: 10.1038/s41467-022-29951-9.'}, {'pmid': '32488505', 'type': 'BACKGROUND', 'citation': 'Grimaud M, Starck J, Levy M, Marais C, Chareyre J, Khraiche D, Leruez-Ville M, Quartier P, Leger PL, Geslain G, Semaan N, Moulin F, Bendavid M, Jean S, Poncelet G, Renolleau S, Oualha M. Acute myocarditis and multisystem inflammatory emerging disease following SARS-CoV-2 infection in critically ill children. Ann Intensive Care. 2020 Jun 1;10(1):69. doi: 10.1186/s13613-020-00690-8.'}, {'pmid': '34049308', 'type': 'DERIVED', 'citation': 'Borgel D, Chocron R, Grimaud M, Philippe A, Chareyre J, Brakta C, Lasne D, Bonnet D, Toubiana J, Angoulvant F, Desvages M, Renolleau S, Smadja DM, Oualha M. Endothelial Dysfunction as a Component of Severe Acute Respiratory Syndrome Coronavirus 2-Related Multisystem Inflammatory Syndrome in Children With Shock. Crit Care Med. 2021 Nov 1;49(11):e1151-e1156. doi: 10.1097/CCM.0000000000005093.'}]}, 'descriptionModule': {'briefSummary': 'The study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.', 'detailedDescription': 'An unexpected increase of shock with fever in children suspected to be infect by the COVID-19 is observed. These children present with similar symptoms and seem to have similar clinical time course.\n\nThis unexpected phenomenon needs to be extensively described in order to further the knowledge of unusual COVID-19 presentation in children.\n\nThe study consists an extensive retrospective data collection from April 2020 till the end of the main SARS-Cov-2 outbreak, from medical file of children have exhibited acute myocarditis and cared in 4 pediatric intensive care units of Assistance Publique-Hôpitaux de Paris of Ile-de-France region.\n\nThe study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children presented with an acute myocarditis, fever and shock with a possible COVID-19 infection cared between April 2020 till the end of the main SARS-Cov-2 outbreak in 4 AP-HP Parisian hospitals :\n\n* Necker-Enfants Malades\n* Armand Trousseau\n* Robert Debré\n* Kremlin Bicêtre', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\< 18 years\n* Admitted to PICU from April 2020\n* Presented with an acute myocarditis, fever and shock with a possible COVID-19 infection\n\nExclusion Criteria:\n\n* Age ≥ 18 years\n* Other etiologies of acute myocarditis than the COVID-19\n* Opposition expressed by the holders of parental authority'}, 'identificationModule': {'nctId': 'NCT04420468', 'acronym': 'HEART-COVID', 'briefTitle': 'Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children', 'orgStudyIdInfo': {'id': 'APHP200632'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Possible COVID-19 infection and acute myocarditis', 'description': 'Children presented with an acute myocarditis, fever and shock with a possible COVID-19 infection cared between April 2020 till the end of the main SARS-Cov-2 outbreak in 4 AP-HP Parisian hospitals :\n\n* Necker-Enfants Malades\n* Armand Trousseau\n* Robert Debré\n* Kremlin Bicêtre'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Hôpital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Armand Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Marion Grimaud', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Sylvain Renolleau, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}