Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04429620
Status:
UNKNOWN
Last Update Posted:
2020-06-25
First Post:
2020-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Assay for SARS-CoV-2 (COVID-19) Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of the method by SARS-CoV2 ELISA compared', 'timeFrame': '8 months', 'description': 'Sensitivity of the method by SARS-CoV2 ELISA compared'}], 'secondaryOutcomes': [{'measure': 'Detectability of the antibodies IgA type against SARS-CoV2 virus', 'timeFrame': '8 months', 'description': 'Detectability of the antibodies IgA type against SARS-CoV2 virus in the early stages of the disease.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sars-CoV2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases', 'label': 'COVID-19 situation update worldwide'}, {'url': 'https://www.worldometers.info/coronavirus/country/italy/', 'label': 'COVID-19 CORONAVIRUS PANDEMIC'}, {'url': 'https://www.medrxiv.org/content/10.1101/2020.03.17.20037713v1.full.pdf', 'label': 'A serological assay to detect SARS-CoV-2 seroconversion in humans'}, {'url': 'https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2020.25.11.2000266', 'label': 'Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland, January to February 2020'}]}, 'descriptionModule': {'briefSummary': 'Prospective assay for SARS-CoV-2 antibody detection indirectly by immunofluorescence: SARS-CoV2 IIF method', 'detailedDescription': 'Sample preparation, serum separation by centrifugation\n\n* 100 µl of serum for standard SARS-CoV2 ELISA is used according to the instructions for use.\n* 100 µl of serum indirect immunofluorescent (IIF) method is used, the samples thus prepared analysis is performed under an automated microscope'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults, Hungarian', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person over 18 years of age\n* Signing a package leaflet and a informal consent\n* In the case of a positive group, confirmed by SARS-CoV2 qPCR Patient with COVID-19 or recovered individual.\n* In case of negative group by SARS-CoV2 qPCR test 2 negative in COVID-19 suffering individual\n\nExclusion Criteria:\n\n* Refuses to sign the consent form'}, 'identificationModule': {'nctId': 'NCT04429620', 'acronym': 'IIF', 'briefTitle': 'Prospective Assay for SARS-CoV-2 (COVID-19) Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method', 'organization': {'class': 'OTHER', 'fullName': 'Szeged University'}, 'officialTitle': 'Prospective Assay for SARS-CoV-2 Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method', 'orgStudyIdInfo': {'id': 'SARS-CoV-2-IIF-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Positive group', 'description': 'Subjects are diagnosed with SARS-CoV2 by qPCR assay.', 'interventionNames': ['Diagnostic Test: Immunfluorescence']}, {'label': 'Negative group', 'description': 'Subject were 2 times proved negative SARS-CoV2 by qPCR assay.', 'interventionNames': ['Diagnostic Test: Immunfluorescence']}], 'interventions': [{'name': 'Immunfluorescence', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.', 'armGroupLabels': ['Negative group', 'Positive group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Szeged', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Katalin Burián, MD', 'role': 'CONTACT', 'phone': '+36 62 544 000'}], 'facility': 'University of Szeged, Albert Szent-Györgyi Health Center', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}], 'centralContacts': [{'name': 'Katalin Burián, MD', 'role': 'CONTACT', 'email': 'burian.katalin@med.u-szeged.hu', 'phone': '+36 62 544 000'}, {'name': 'Dávid Pintér, Pharm. D.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Katalin Burián, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Szeged, Institute of Clinical Microbilogy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Szeged University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bilogical Research Centre, Szeged', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}