Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 6:21 PM
Study NCT ID:
NCT05382234
Status:
UNKNOWN
Last Update Posted:
2022-05-19
First Post:
2022-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multisystem Inflammatory Syndrome In Children at Sohag University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-15', 'releaseDate': '2024-07-01'}], 'estimatedResultsFirstSubmitDate': '2024-07-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'C000705967', 'term': 'pediatric multisystem inflammatory disease, COVID-19 related'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001772', 'term': 'Blood Cell Count'}], 'ancestors': [{'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-15', 'studyFirstSubmitDate': '2022-05-15', 'studyFirstSubmitQcDate': '2022-05-15', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmed or suspected cases of Multisystem inflammatory syndrome in children', 'timeFrame': '1 year', 'description': 'Confirmed or suspected cases Multisystem inflammatory syndrome in children based On WHO Criteria of MIS-C\n\n1. Age 0-19 years.\n2. Fever for ≥3 days.\n3. Clinical signs of multi system involvement (at least 2 of the following):\n\n 1. Rash, bilateral non purulent conjunctivitis, or mucocutaneous inflammation signs\n 2. Hypotension or shock\n 3. Evidence of coagulopathy (prolonged PT or PTT)\n 4. Acute gastrointestinal symptoms (diarrhea , vomiting, or abdominal pain)\n4. Elevated markers of inflammation (eg ESR, CRP)\n5. No other obvious microbial cause of inflammation.\n6. Evidence of SARS-CoV-2 infection (Any of the following: Positive SARS-CoV-2 RT-PCR ,positive serology, COVID 19 exposure within the 4 weeks prior to the onset of symptoms).\n\naccording to CDC criteria exposure to a patients with suspected or confirmed COVID-19 within the 4 weeks prior to the onset of symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multisystem Inflammatory Syndrome in Children']}, 'referencesModule': {'references': [{'pmid': '32087114', 'type': 'BACKGROUND', 'citation': 'Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.'}, {'pmid': '32386565', 'type': 'BACKGROUND', 'citation': 'Riphagen S, Gomez X, Gonzalez-Martinez C, Wilkinson N, Theocharis P. Hyperinflammatory shock in children during COVID-19 pandemic. Lancet. 2020 May 23;395(10237):1607-1608. doi: 10.1016/S0140-6736(20)31094-1. Epub 2020 May 7. No abstract available.'}, {'pmid': '32423970', 'type': 'BACKGROUND', 'citation': 'Alunno A, Carubbi F, Rodriguez-Carrio J. Storm, typhoon, cyclone or hurricane in patients with COVID-19? Beware of the same storm that has a different origin. RMD Open. 2020 May;6(1):e001295. doi: 10.1136/rmdopen-2020-001295.'}, {'pmid': '28466096', 'type': 'BACKGROUND', 'citation': 'Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.'}]}, 'descriptionModule': {'briefSummary': 'Since its initial description in December 2019 in Wuhan , China, Corona virus disease 2019 (COVID-19), caused by infection with severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), has rapidly evolved into a worldwide pandemic affecting millions of lives .\n\nUnlike adults, the vast majority of children with COVID-19 have mild symptoms. However, there are children who have significant respiratory disease, and some children may develop a hyper inflammatory response similar to what has been observed in adults with COVID-19. Furthermore, in late April 2020, reports emerged of children with a different clinical syndrome resembling Kawasaki disease (KD) and toxic shock syndrome; these patients frequently had evidence of prior exposure to SARS-CoV-2.\n\nThe pathophysiology of MIS-C:\n\nIs unclear ,but it appears to be a consequence of a exacerbated immune system response or maladaptive response of the host .After the virus enters the human cells, the first line of defense against infection should be a quick and well-coordinated immune response ;however, when this mechanism is unregulated and excessive ,hyper inflammation can occur.\n\nCytokines that play an important role in inducing immunity and immunopathology during infections in excess can cause the clinical syndrome known as cytokine storm. The inflammatory response caused by SARS-CoV-2appears to be the major cause of mortality in infected patients .\n\nThe infection of dendritic cells or macrophages by SARS-CoV-2 induces the production of low levels of antiviral cytokines and increases the production of inflammatory cytokines (tumor necrosis factor\\[TNF\\], interleukin\\[IL\\]-1, IL-6,and interferon ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Multisystem inflammatory syndrome in children', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAny suspected case of MIS-C from birth to 12 year included both sexes fulfill criteria of MIS-C (WHO) .\n\n1. Fever for ≥3 days.\n2. Clinical signs of multi system involvement (at least 2 of the following):\n\n 1. Rash, bilateral non purulent conjunctivitis, or mucocutaneou inflammation signs (oral, hands, or feet)\n 2. Hypotension or shock\n 3. Cardiac dysfunction, pericarditis, valvulitis , or coronary abnormalities (including echocardiographic findings or elevated troponin)\n 4. Evidence of coagulopathy (prolonged PT or PTT)\n 5. Acute gastrointestinal symptoms (diarrhea , vomiting, or abdominal pain)\n\n4\\. Elevated markers of inflammation (eg ESR, CRP) 5. No other obvious microbial cause of inflammation. 6. Evidence of SARS-CoV-2 infection (Any of the following: Positive SARS-CoV-2 RT-PCR ,positive serology, COVID 19 exposure within the 4 weeks prior to the onset of symptoms).\n\naccording to CDC criteria exposure to a patients with suspected or confirmed COVID-19 within the 4 weeks prior to the onset of symptoms.\n\nExclusion Criteria:\n\n* Other obvious microbial cause of inflammation, including bacterial sepsis and staphylococcal/streptococcal toxic shock syndromes.'}, 'identificationModule': {'nctId': 'NCT05382234', 'briefTitle': 'Multisystem Inflammatory Syndrome In Children at Sohag University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Multisystem Inflammatory Syndrome In Children at Sohag University Hospital', 'orgStudyIdInfo': {'id': 'Soh-Med-22-05-12'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CBC, ESR ,CRP,Liver Function ,renal function ,ABG,Na,K,D-dimmer ,cardiac enzyme,ferritin ,blood and urine culture in negative cases', 'type': 'DIAGNOSTIC_TEST', 'description': 'cllinical and laboratory evaluation of MIS-C,Effectivness of different therapeutic modalities,Outcome of cases (morbidity,mortality)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Osama R Elshirief, professor', 'role': 'CONTACT'}], 'facility': 'Sohag university hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Youstina R Attia, residant', 'role': 'CONTACT', 'email': 'youstinarashed@med.sohag.edu.eg', 'phone': '01275866826'}, {'name': 'Osama R Elsherief, Professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident docotor pediatric department Facuity Of Medicine Sohag University', 'investigatorFullName': 'Youstena Rashed Attia', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-07-01', 'type': 'RELEASE'}, {'date': '2024-10-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Youstena Rashed Attia, Resident docotor pediatric department Facuity Of Medicine Sohag University, Sohag University'}}}}