Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-30 @ 2:16 AM
Study NCT ID:
NCT04320732
Status:
RECRUITING
Last Update Posted:
2021-12-13
First Post:
2020-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Community- and Workplace Transmission of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067289', 'term': 'Behavior Observation Techniques'}], 'ancestors': [{'id': 'D011580', 'term': 'Psychological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and upper repiratory samples will be collected from some participants.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2030-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-29', 'studyFirstSubmitDate': '2020-03-23', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of COVID-19 infection', 'timeFrame': '1 year', 'description': 'Diagnosed with serology or direct viral detection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus']}, 'descriptionModule': {'briefSummary': 'The project is an epidemiological observational study based on an electronic questionnaire on risk factors for COVID-19 in the community and healthcare setting.', 'detailedDescription': 'Summary The data collected will identify real-life risk factors for getting the COVID-19 diagnosis.\n\nThe Oslo University Hospital/University of Oslo web-based solution "nettskjema" will be used to collect data and consent forms.\n\nThe impact of knowing the risk factors for COVID-19 is tremendous because it can enable governments to conduct more targeted public health measurements than today to reduce the spread of the virus.\n\nDetailed description Research into an ongoing COVID-19 outbreak is difficult because patients are isolated, and supplies of personal protective equipment (PPE) supplies are limited. The risk of transmission to study personal is non-negligible even when PPE is available.\n\nA study design based on an electronic questionnaire and consent from delivered from the Oslo University Hospital/University of Oslo, GDPR (General Data Protection Regulation) compliant "TSD" service has therefore been chosen.\n\nThe study will be a case-control study based on a combined electronic consent form and questionnaire that the participants will fill in using a smartphone and electronic identification.\n\nThe groups that will be included are:\n\n* Hospitalized and non-hospitalized patients/persons with COVID-19 at all stages of the disease and after the disease\n* Hospitalized patients without COVID-19\n* Healthcare personal or other groups with an increased risk of COVID-19\n* Healthy volunteers\n\nParticipants may be followed with repeated questionnaires prospectively.\n\nBiological samples Biological samples may hold crucial information about the susceptibility to COVID-19 and for susceptibility to the progression of the disease. It is within the scope of the study to analyze such samples from a limited number of participants which will be asked to provide such samples or hospitalized patients that have surplus material. The material will be analyzed with non-genetic methods most suitable to provide such information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be a combined retrospective and prospective case-control study based on a combined electronic consent form and questionnaire that the study groups will fill in using a smartphone and electronic identification.\n\nThe groups that will be included are:\n\n* Hospitalized and non-hospitalized patients/persons with COVID-19 at all stages of the disease and after the disease\n* Hospitalized patients without COVID-19\n* Healthcare personal or other groups with an increased risk of COVID-19\n* Healthy volunteers\n\nProbability sampling will be conducted, but not solely.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Norwegian adult\n\nExclusion Criteria:\n\n* Unable to consent'}, 'identificationModule': {'nctId': 'NCT04320732', 'briefTitle': 'Risk Factors for Community- and Workplace Transmission of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Risk Factors for Community- and Workplace Transmission of COVID-19', 'orgStudyIdInfo': {'id': 'REK-124170'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with COVID-19 infection', 'description': 'Confirmed by routine laboratory diagnosis. All types of COVID-19 disease from asymptomatic carriers to hospitalized patients can be included.\n\nOnly subjects \\>18 years old will be included in the study.', 'interventionNames': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}, {'label': 'Individuals tested for COVID-19 infection with negative test', 'description': 'Confirmed by routine laboratory diagnosis', 'interventionNames': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}, {'label': 'Healthy individuals', 'description': 'Recruitet from the general population', 'interventionNames': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}, {'label': 'Risk groups for COVID-19 exposure', 'description': 'Including, but not limited to healthcare workers.', 'interventionNames': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}, {'label': 'Patients admitted to hospital', 'description': 'Without COVID-19 infection.', 'interventionNames': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}], 'interventions': [{'name': 'Observation of behavior and COVID-19 infection will be conducted.', 'type': 'BEHAVIORAL', 'description': 'No intervention, only prospective observation of behavior will be conducted by a questionnaire.', 'armGroupLabels': ['Healthy individuals', 'Individuals tested for COVID-19 infection with negative test', 'Individuals with COVID-19 infection', 'Patients admitted to hospital', 'Risk groups for COVID-19 exposure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Arne Søraas, PhD', 'role': 'CONTACT', 'email': 'Arne.Vasli.Lund.Soraas@rr-research.no', 'phone': '+4790652904'}, {'name': 'John A Dahl, PhD', 'role': 'CONTACT', 'email': 'j.a.dahl@medisin.uio.no', 'phone': '+4741456596'}], 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Arne Søraas, MD, PhD', 'role': 'CONTACT', 'email': 'Arne.Vasli.Lund.Soraas@rr-research.no', 'phone': '+4790652904'}, {'name': 'John Arne Dahl, PhD', 'role': 'CONTACT', 'email': 'j.a.dahl@medisin.uio.no'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'European GDPR regulations severely limits IPD, but the study will share data to the largest extent possible within GDPR.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Age Labs AS', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD, PhD', 'investigatorFullName': 'Arne Vasli Lund Søraas', 'investigatorAffiliation': 'Oslo University Hospital'}}}}