Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-28 @ 5:07 PM
Study NCT ID:
NCT05566392
Status:
RECRUITING
Last Update Posted:
2024-08-06
First Post:
2022-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longterm Influence of Pediatric Long COVID Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'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'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2022-10-02', 'studyFirstSubmitQcDate': '2022-10-02', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between COVID and healthy group', 'timeFrame': '1 years after enrollment for primary evaluation', 'description': 'The neuroimage difference between COVID and healthy group and the correlation with neuropsychiatric evaluation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric neurology', 'psychiatric evaluation', 'Long COVID syndrome', 'magnetic resonance image'], 'conditions': ['COVID-19-Associated Encephalitis', 'Long COVID']}, 'descriptionModule': {'briefSummary': 'We enroll pediatric patients who were diagnosed COVID-19 for main observation target. We will perform brain MRI and neuropsychiatric evaluation 4-6 months after COVID-19 diagnosed. We also enroll healthy age- and gender-matched participant for cross-over comparison. We will perform same evaluation process one year later for longitudinal evaluation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Aged between 6-18 years old pediatric patient diagnosed as COVID would be enrolled. The patient who had neuropsychiatric disorders would be excluded. We also enroll age- and gender-matched healthy participants for cross-over comparison', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 6-18 years old\n* Has been diagnosed COVID-19 before\n\nExclusion Criteria:\n\n* History of neuropsychiatric disorders\n* Have some device not allowed for MRI'}, 'identificationModule': {'nctId': 'NCT05566392', 'briefTitle': 'Longterm Influence of Pediatric Long COVID Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Longterm Influence of Pediatric Long COVID Syndrome on the Neuropsychiatric Function, Social Function, Neuroimage, and Gut Microbiota', 'orgStudyIdInfo': {'id': '202208086RIND'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronavirus disease (COVID)', 'description': 'Pediatric patients who was diagnosed as COVID', 'interventionNames': ['Diagnostic Test: Brain MRI']}, {'label': 'Healthy', 'description': "Pediatric participants who hadn't been diagnosed COVID before", 'interventionNames': ['Diagnostic Test: Brain MRI']}], 'interventions': [{'name': 'Brain MRI', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Neuropsychiatric evaluation', 'Near infrared spectroscopy'], 'description': 'Brain MRI including diffusion spectrum image, and functional MRI Interview with questionnaires for neuropsychiatric evaluation Near infrared spectroscopy and resting-state connectivity evaluation', 'armGroupLabels': ['Coronavirus disease (COVID)', 'Healthy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wang-Tso Lee, PHD', 'role': 'CONTACT', 'email': 'leeped@hotmail.com', 'phone': '(886)2-23123456', 'phoneExt': '71618'}], 'facility': 'National Taiwan University Children Hospital Pediatric Neurology Department', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Wang-Tso Lee, PHD', 'role': 'CONTACT', 'email': 'leeped@hotmail.com', 'phone': '(886)2-23123456', 'phoneExt': '71618'}], 'overallOfficials': [{'name': 'Wang-Tso Lee, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Children Hospital Pediatric neurology department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'according to our participant consent, the participant information will be stored as de-identification data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}