Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-25 @ 5:12 PM
Study NCT ID:
NCT04514003
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-29
First Post:
2020-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Corona and COVID-19 Study in Telemark and Agder
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples for SARS-CoV-2 IgG antibody testing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2035-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2020-08-13', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS-CoV-2 IgG antibody level', 'timeFrame': '2020-2023', 'description': 'Serum Levels of SARS-CoV-2 IgG antibody and the Development of these over a two years period'}, {'measure': 'Risk factors for COVID-19', 'timeFrame': '2020-2026', 'description': 'Different risk factors (age, sex, education, comorbidity, occupational and environmental exposure will be assessed'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunity', 'Risk factors', 'Test-negative design', 'Population controls'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '40462062', 'type': 'DERIVED', 'citation': 'Sarjomaa M, Berg KK, Jaioun K, Tveten Y, Kersten H, Reiso H, Eikeland R, Thilesen C, Nordbo SA, Aaberge IS, Pearce N, Fell AKM. SARS-CoV-2-specific humoral immunity in a Norwegian cohort between 2020 and 2023. BMC Med. 2025 Jun 3;23(1):332. doi: 10.1186/s12916-025-04171-2.'}]}, 'descriptionModule': {'briefSummary': 'Through SARS-CoV-2 IgG testing of PCR positive and negative cases the study will follow the COVID-19 immune response by monitoring the SARS-CoV-2 IgG antibody levels over a period of two years. Further, risk factors will be identified by the use of the test-negative design including population controls, allowing comparison of participants with positive and negative tests, and with population controls (triangulation). Special emphasis will be on high risk groups in general and on different occupational, environmental and socio-economic groups in particular. Finally, severity of illness, deaths and the use of health care during will be assessed using national register data from Telemark and Agder.', 'detailedDescription': "Objectives\n\nThe main objectives are:\n\n1. Monitor the incidence of COVID-19 and the development of the SARS-CoV-2-IgG levels of cases in Agder and Telemark over a period of two years (WP1).\n2. Identify risk factors for COVID-19 by comparison of SARS-CoV-2 antibody positive and negative cases in Telemark and Agder, and comparison of these groups separately with population controls (WP2).\n3. The incidence of neurocognitive symptoms and fatigue in COVID-19 patients (WP3).\n4. Investigation of severity, death and the use of health care for the COVID-19 patients based on data from national registers (WP4).\n\nThe main exposures are (WP1-3):\n\n* Infection (mild, severe) with COVID-19.\n* Occupational risk factors assessed by occupational codes (ISCO88) and job exposure matrix categorisation.\n* Environmental risk factors (road traffic outside bedroom window, travel by foot or bicycle alongside busy roads, and the use of a fireplaces in residential homes. Further, estimated measurements of air pollution may be linked to participants' home address.\n* Socioeconomic status; age, sex, comorbidity, medication use, lifestyle factors (smoking, BMI, physical activity, others), geographic region/municipality, education and income."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inhabitants of Agder and Telemark County in Norway fulfilling the inclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 85 years\n* Performed SARS-CoV-2 PCR test\n\nExclusion Criteria:\n\n* Non-Norwegian speakers.\n* Deceased\n* inability to answer questionnaire due to dementia or similar conditions'}, 'identificationModule': {'nctId': 'NCT04514003', 'acronym': 'COVITA', 'briefTitle': 'The Corona and COVID-19 Study in Telemark and Agder', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sykehuset Telemark'}, 'officialTitle': 'The Corona and COVID-19 Study in Telemark and Agder - COVITA', 'orgStudyIdInfo': {'id': 'COVITA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SARS-CoV-2 PCR positive cases', 'description': 'Antibody tests will be performed every 6 months for 2 years'}, {'label': 'SARS-CoV-2 PCR negative cases', 'description': 'Antibody tests will be performed at baseline'}, {'label': 'Population controls', 'description': 'A large sample (n= 22500) from the general population will be included to assess risk factors. No blood sample will be collected for this group and the data needed is already collected.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3710', 'city': 'Skien', 'state': 'Vestfold and Telemark', 'country': 'Norway', 'facility': 'Telemark Hospital', 'geoPoint': {'lat': 59.20962, 'lon': 9.60897}}], 'overallOfficials': [{'name': 'Anne Kristin M. Fell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sykehuset Telemark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sykehuset Telemark', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, {'name': 'Norwegian Institute of Public Health', 'class': 'OTHER_GOV'}, {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, {'name': 'Leiden University', 'class': 'OTHER'}, {'name': 'Aalborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, senior physician', 'investigatorFullName': 'Anne Kristin M. Fell', 'investigatorAffiliation': 'Sykehuset Telemark'}}}}