Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 4:33 PM
Study NCT ID:
NCT04347694
Status:
UNKNOWN
Last Update Posted:
2020-09-02
First Post:
2020-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine the Immunization Status Among Nephrological Health Care Personnel Against SARS-CoV-2 in a Single Center Over the Course of 12 Months During the Worldwide COVID-19 Pandemic.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-04-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2020-04-12', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Status of Immunization', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nephrology', 'SARS-CoV-2', 'Vienna', 'Health Care Personnel'], 'conditions': ['SARS-CoV 2', 'Immunization; Infection']}, 'referencesModule': {'references': [{'pmid': '35746653', 'type': 'DERIVED', 'citation': 'Gerges D, Kapps S, Hernandez-Carralero E, Freire R, Aiad M, Schmidt S, Winnicki W, Reiter T, Pajenda S, Schmidt A, Sunder-Plassmann G, Wagner L. Vaccination with BNT162b2 and ChAdOx1 nCoV-19 Induces Cross-Reactive Anti-RBD IgG against SARS-CoV-2 Variants including Omicron. Viruses. 2022 May 28;14(6):1181. doi: 10.3390/v14061181.'}, {'pmid': '33835265', 'type': 'DERIVED', 'citation': 'Reiter T, Pajenda S, Wagner L, Gaggl M, Atamaniuk J, Holzer B, Zimpernik I, Gerges D, Mayer K, Aigner C, Strassl R, Jansen-Skoupy S, Fodinger M, Sunder-Plassmann G, Schmidt A. COVID-19 serology in nephrology healthcare workers. Wien Klin Wochenschr. 2021 Sep;133(17-18):923-930. doi: 10.1007/s00508-021-01848-5. Epub 2021 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'Infections with Corona-Viruses have shown to be a menace for patients with comorbidities such as hypertension, diabetes, cardiovascular disease or immunosuppression. Those are features almost every nephrological patient brings along, especially those on maintenance dialysis and those with renal transplant. Since the emergence of the novel coronavirus SARS-CoV-2 in November 2019 in Mainland China the fear for pandemic infections has increased. But not only is the course of infection itself important, the prevention of transmission to and by attending medical personnel should be put into perspective. Thus there is a lack of sufficient data of occult immunization or persistent state on immunization.\n\nIn our study up to 400 health care personnel will be screened serologically for IgM, IgA and IgG against the SARS-CoV-2 virus. Blood and urine samples throughout 12 months will be sampled and analyzed.\n\nThe aim of the study is to identify the rate of occult immunization and at the same time to gather data about the persistence of immune response to an infection with SARS-CoV-02. The results will help provide sufficient safety measures for health care providers and renal patients undergoing unavoidable clinical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Health Care Personnel', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health Care Personnel and other staff at the Division of Nephrology \\& Dialysis at the Medical\n\nExclusion Criteria:\n\n* Not matching the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT04347694', 'acronym': 'CONEC', 'briefTitle': 'Study to Determine the Immunization Status Among Nephrological Health Care Personnel Against SARS-CoV-2 in a Single Center Over the Course of 12 Months During the Worldwide COVID-19 Pandemic.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'COVID-19 Serology in Nephrology Health Care Workers', 'orgStudyIdInfo': {'id': '1357/2020'}}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Thomas J Reiter, MD', 'role': 'CONTACT', 'email': 'thomas.reiter@meduniwien.ac.at'}, {'name': 'Gere Sunder-Plassmann, MD', 'role': 'CONTACT', 'email': 'gere.sunder-plassmann@meduniwien.ac.at'}, {'name': 'Thomas J Reiter, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Vienna, Division for Nephrology and Dialysis', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Thomas J Reiter, MD', 'role': 'CONTACT', 'email': 'thomas.reiter@meduniwien.ac.at', 'phone': '+43140400', 'phoneExt': '43910'}], 'overallOfficials': [{'name': 'Thomas J Reiter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist in Internal Medicine', 'investigatorFullName': 'Dr. Thomas Reiter', 'investigatorAffiliation': 'Medical University of Vienna'}}}}