Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT04811456
Status:
UNKNOWN
Last Update Posted:
2021-03-26
First Post:
2021-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MultiOrgan Inflammatory Syndromes COVID-19 Related Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'C000705967', 'term': 'pediatric multisystem inflammatory disease, COVID-19 related'}], '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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2025-08-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-23', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PICU', 'timeFrame': '5 years', 'description': 'pediatric intensive care unit treatment need'}], 'secondaryOutcomes': [{'measure': 'Heart dysfunction', 'timeFrame': '5 years', 'description': 'Heart dysfunction is defined as ejection fraction (EF) of \\<55% and severe heart dysfunction as EF \\<35%.'}, {'measure': 'CAA', 'timeFrame': '5 years', 'description': 'Coronary artery abnormalities comprise both coronary dilation and/or coronary aneurysm. Dilation was defined by Z-score between 2 to 2.5, while aneurysm by Z score ≥2.5'}, {'measure': 'Hypotension', 'timeFrame': '5 years', 'description': 'Hypotension is defined by a minimal systolic blood pressure (sBP) below 70+2×age (in years) mmHg or below 90 mmHg for children \\>10 years old'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MIS-C', 'PIMS-TS', 'COVID-19', 'hyperinflammation', 'children'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The study comprise a nationwide, voluntary, on-line survey of inflammatory syndromes in children for retrospective (since 4th March 2020) and prospective data collection. Our aim was to capture and describe multisystem inflammatory syndrome in children (MIS-C) in Poland.', 'detailedDescription': 'The voluntary surveillance for retrospective (since 4th March) and prospective data collection was initiated under the National Consultant of Pediatrics auspices. Anonymized patient data from pediatric hospitals from all over the country are extracted from electronic and paper records and collected through online form developed for that purpose. Before the surveillance was launched, reporting clinicians underwent an online training, which included the current state of knowledge about multisystem inflammatory syndrome in children (MIS-C). Patient management is at the discretion of the relevant treating clinicians.\n\nKD and aKD were defined following the American Heart Association (AHA) guidelines.\n\nTSS was established based on modified criteria by the Centers for Disease Control and Prevention.\n\nMAS was diagnosed based on the Paediatric Rheumatology International Trials Organization (PRINTO) criteria for MAS classification.\n\nThe definition of the inflammatory syndrome was based on the WHO MIS-C definition with the exclusion of SARS-CoV-2 confirmation.\n\nFor patients who met the inclusion criteria, demographic data, past medical history, data on COVID-19 exposure, clinical symptoms, physical examination findings, laboratory, imaging, and cardiologic tests results, treatment, and outcome data are collected.\n\nAll study definitions are defined in accordance to relevant guidelines and evaluated automatically with the use of a dedicated software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 0-18 years old hospitalized with inflammatory conditions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who required hospitalization since 4th March 2020;\n* diagnosed Kawasaki disease (KD) or incomplete (atypical) Kawasaki disease (aKD) or toxic shock syndrome (TSS) or macrophage activation syndrome (MAS) or unspecified inflammatory syndrome;\n\nExclusion Criteria:\n\n* other infectious and non-infectious causes that could be responsible for the disease\n\nSARS-CoV-2 polymerase chain reaction (PCR) or serology result could have been positive or negative. Due to limited availability and reliability of serologic testing, proven or likely COVID-19 criterion was not a condition determining inclusion to the registry.'}, 'identificationModule': {'nctId': 'NCT04811456', 'acronym': 'MOIS-CoR', 'briefTitle': 'MultiOrgan Inflammatory Syndromes COVID-19 Related Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'MultiOrgan Inflammatory Syndromes COVID-19 Related Study', 'orgStudyIdInfo': {'id': 'MOIS-CoR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MIS-C', 'description': 'Cases fulfilling following criteria:\n\n1. fever ≥3 days\n2. at least two of the following:\n\n * rash or bilateral conjunctivitis or mucocutaneous inflammation signs\n * hypotension\n * features of myocardial dysfunction, pericarditis, or coronary artery abnormality, based on echocardiographic findings or elevated B-type natriuretic peptide (BNP)/N-terminal-pro-BNP (NT-proBNP) or troponin\n * evidence of coagulopathy\n * acute gastrointestinal problems\n3. elevated inflammatory markers AND\n4. no other apparent microbial cause\n5. evidence of COVID-19 (positive real-time polymerase chain reaction, antigen test or serology), or personal history of COVID-19 or contact with a proven COVID-19 case', 'interventionNames': ['Other: multisystem inflammatory syndrome in children (MIS-C)']}], 'interventions': [{'name': 'multisystem inflammatory syndrome in children (MIS-C)', 'type': 'OTHER', 'description': 'as in group description', 'armGroupLabels': ['MIS-C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02091', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Magdalena Okarska-Napierala, MD', 'role': 'CONTACT', 'email': 'mnapierala@wum.edu.pl', 'phone': '+48 503 065 849'}], 'facility': "Medical University of Warsaw Children's Hospital", 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-368', 'city': 'Wroclaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Kamila Ludwikowska', 'role': 'CONTACT', 'email': 'kama.ludwikowska@gmail.com'}], 'facility': 'Wroclaw Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Magdalena Okarska-Napierała, PhD', 'role': 'CONTACT', 'email': 'magda.okarska@gmail.com', 'phone': '+48503065849'}, {'name': 'Natalia Dudek, MD', 'role': 'CONTACT', 'email': 'natalia.dudek@gmail.com'}], 'overallOfficials': [{'name': 'Magdalena Okarska-Napierała', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wrocław Medical University', 'class': 'UNKNOWN'}, {'name': 'University of Warsaw', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}