Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-08 @ 7:33 PM
Study NCT ID:
NCT04635592
Status:
UNKNOWN
Last Update Posted:
2020-11-20
First Post:
2020-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serological Diagnostics of COVID-19 in Health Care Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'SARS-CoV2 nasal swabs Venous blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-18', 'studyFirstSubmitDate': '2020-11-17', 'studyFirstSubmitQcDate': '2020-11-17', 'lastUpdatePostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'positive nasal swab and serological test', 'timeFrame': '2 months', 'description': 'Rate of positive nasal swab and serological tests for SARS-CoV2 among health care workers'}], 'secondaryOutcomes': [{'measure': 'Relation of positive SARS-CoV2 tests to risky contact history', 'timeFrame': '8 months', 'description': 'Relation of positive SARS-CoV2 tests to history of contacts with COVID-19 infected patients since the beginning of pandemia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV2 infection', 'Health care worker', 'Serology', 'Nasal swab tests', 'Anesthesiology and Intensive Care'], 'conditions': ['SARS-CoV Infection']}, 'referencesModule': {'references': [{'pmid': '32641730', 'type': 'BACKGROUND', 'citation': 'Garcia-Basteiro AL, Moncunill G, Tortajada M, Vidal M, Guinovart C, Jimenez A, Santano R, Sanz S, Mendez S, Llupia A, Aguilar R, Alonso S, Barrios D, Carolis C, Cistero P, Choliz E, Cruz A, Fochs S, Jairoce C, Hecht J, Lamoglia M, Martinez MJ, Mitchell RA, Ortega N, Pey N, Puyol L, Ribes M, Rosell N, Sotomayor P, Torres S, Williams S, Barroso S, Vilella A, Munoz J, Trilla A, Varela P, Mayor A, Dobano C. Seroprevalence of antibodies against SARS-CoV-2 among health care workers in a large Spanish reference hospital. Nat Commun. 2020 Jul 8;11(1):3500. doi: 10.1038/s41467-020-17318-x.'}, {'pmid': '33033249', 'type': 'BACKGROUND', 'citation': 'Rudberg AS, Havervall S, Manberg A, Jernbom Falk A, Aguilera K, Ng H, Gabrielsson L, Salomonsson AC, Hanke L, Murrell B, McInerney G, Olofsson J, Andersson E, Hellstrom C, Bayati S, Bergstrom S, Pin E, Sjoberg R, Tegel H, Hedhammar M, Phillipson M, Nilsson P, Hober S, Thalin C. SARS-CoV-2 exposure, symptoms and seroprevalence in healthcare workers in Sweden. Nat Commun. 2020 Oct 8;11(1):5064. doi: 10.1038/s41467-020-18848-0.'}, {'pmid': '32491919', 'type': 'BACKGROUND', 'citation': 'Oran DP, Topol EJ. Prevalence of Asymptomatic SARS-CoV-2 Infection : A Narrative Review. Ann Intern Med. 2020 Sep 1;173(5):362-367. doi: 10.7326/M20-3012. Epub 2020 Jun 3.'}, {'pmid': '32870978', 'type': 'BACKGROUND', 'citation': 'Gomez-Ochoa SA, Franco OH, Rojas LZ, Raguindin PF, Roa-Diaz ZM, Wyssmann BM, Guevara SLR, Echeverria LE, Glisic M, Muka T. COVID-19 in Health-Care Workers: A Living Systematic Review and Meta-Analysis of Prevalence, Risk Factors, Clinical Characteristics, and Outcomes. Am J Epidemiol. 2021 Jan 4;190(1):161-175. doi: 10.1093/aje/kwaa191.'}]}, 'descriptionModule': {'briefSummary': 'All health care workers at the Department of Anesthesiology and Intensive Care at UMC Ljubljana will be tested for SARS-CoV2 with nasal swab test and blood withdrawal for SARS-CoV2 antibodies. At the same time a questionnaire with epidemiological anamnesis, risky contacts and the use of personal protective equipment will be fulfilled.', 'detailedDescription': 'Health care workers at the Department of Anesthesiology and Intensive Care at UMC Ljubljana are working with COVID-19 patients in intensive care units, operating theaters, wards and emergency department. In the care of those patients different workgroups are involved: anesthesiologists, anesthesia and ICU nurses and respiratory therapeuts.There is insufficient data on the seroprevalence in different workgroups, different areas of the hospital, insufficient data on connection between SARS-CoV2 nasal swabs and antibodies and the rate of asymptomatic infections.\n\n300 hundred HCW will be tested for SARS-CoV2 with nasal swab test and blood withdrawal for SARS-CoV2 antibodies. At the same time a questionnaire with epidemiological anamnesis, risky contacts and the use of personal protective equipment will be filled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Health care workers at Department of Anesthesiology and Intensive Care at UMC Ljubljana', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* employee of Department of Anesthesiology and Intensive Care at UMC Ljubljana\n* active current employment at the department\n\nExclusion Criteria:\n\n* current sick-leave'}, 'identificationModule': {'nctId': 'NCT04635592', 'acronym': 'KORANIT', 'briefTitle': 'Serological Diagnostics of COVID-19 in Health Care Workers', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Serological Diagnostics of COVID-19 and Risk Factors for Infection Among Different Groups of Health Care Workers at Surgical Division at Tertiary Hospital', 'orgStudyIdInfo': {'id': 'KOAIT-1-2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SARS-CoV2 nasal swab', 'type': 'DIAGNOSTIC_TEST', 'description': 'SARS-CoV2 nasal swab and venous blood for SARS-CoV2 antibodies'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'contacts': [{'name': 'Peter Poredos, MD, PhD', 'role': 'CONTACT', 'email': 'peter.poredos@kclj.si', 'phone': '+38615229455'}, {'name': 'Marko Zlicar, MD, PhD', 'role': 'CONTACT', 'email': 'marko.zlicar@kclj.si'}], 'facility': 'University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Peter Poredos, MD, PhD', 'role': 'CONTACT', 'email': 'peter.poredos@kclj.si', 'phone': '+38615229455'}], 'overallOfficials': [{'name': 'Peter Poredos, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology and Intensive Care - Hear'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. prof.', 'investigatorFullName': 'Peter Poredos', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}