Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-04 @ 11:33 AM
Study NCT ID:
NCT04686734
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2020-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Effects of COVID-19 in Adolescents
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-31', 'size': 782627, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-01-31T08:11', 'hasProtocol': True}, {'date': '2022-01-31', 'size': 812302, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-01-31T08:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 516}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2020-12-27', 'studyFirstSubmitQcDate': '2020-12-27', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': '6 months follow-up', 'description': 'Total sum score on the Chalder Fatigue Scale (range 0 - 33, lower scores means less fatigue, ie. better outcome)'}, {'measure': 'Post-COVID-19 syndrome caseness', 'timeFrame': '6 months follow-up', 'description': 'Post-COVID-19 syndrome casesness according to the WHO definition (issued Sept. 2021; hence, this endpoint was added during the course of the study, but prior to database lock.)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '35222429', 'type': 'DERIVED', 'citation': 'Lund Berven L, Selvakumar J, Havdal L, Stiansen-Sonerud T, Einvik G, Leegaard TM, Tjade T, Michelsen AE, Mollnes TE, Wyller VBB. Inflammatory Markers, Pulmonary Function, and Clinical Symptoms in Acute COVID-19 Among Non-Hospitalized Adolescents and Young Adults. Front Immunol. 2022 Feb 9;13:837288. doi: 10.3389/fimmu.2022.837288. eCollection 2022.'}], 'seeAlsoLinks': [{'url': 'https://www.ahus.no/kliniske-studier/langtidseffekter-etter-koronavirusinfeksjon-covid-19-hos-ungdommer', 'label': 'Information for patients and other public stakeholders'}]}, 'descriptionModule': {'briefSummary': 'The overarching objective for this prospective cohort study of COVID-19 in adolescents is to study the long-term effects, with particular emphasis on post-infectious chronic fatigue. A total of 500 individuals with a SARS-CoV-2 positive test will be enrolled in the acute phase of COVID-19 and followed for 6 months. A total of 100 individuals with SARS-CoV-2 negative test will be included during the same time period as a control group. Investigations include autonomic, pulmonary and cognitive assessement; a questionnaire charting symptoms, emotionality, personality, loneliness, life events and demographics; and extensive biobanking including genetic markers, viable PBMC, urine, feces and hair. A subgroup of 40 SARS-CoV-2 positive and 20 SARS-CoV-2 negative individuals will also undergo detailed cardiological examination by echocardiography. Primary endpoints are fatigue at 6 months as assessed by the Chalder Fatigue Scale and post-COVID-19 syndrome cases at 6 months according to the WHO definition'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents living in the counties of Oslo and Viken, Norway', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive SARS-CoV-2 test/negative SARS-CoV-2 test\n* Age 12 - 25 years\n* Living in the counties of Oslo or Viken, Norway\n* \\< 28 days since onset of first symptom\n\nExclusion Criteria:\n\n* Hospitalised due to COVID-19\n* Pregnancy\n* Lack of consent'}, 'identificationModule': {'nctId': 'NCT04686734', 'acronym': 'LoTECA', 'briefTitle': 'Long-term Effects of COVID-19 in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Long-term Effects of COVID-19 in Adolescents', 'orgStudyIdInfo': {'id': 'LoTECA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SARS-CoV-2 positive', 'interventionNames': ['Other: No active intervention (observational only)']}, {'label': 'SARS-CoV-2 negative', 'interventionNames': ['Other: No active intervention (observational only)']}], 'interventions': [{'name': 'No active intervention (observational only)', 'type': 'OTHER', 'description': 'No active intervention (observational only)', 'armGroupLabels': ['SARS-CoV-2 negative', 'SARS-CoV-2 positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1170', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Vegard Bratholm Wyller', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Vegard B Wyller, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Akershus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Vegard Wyller', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}