Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-01 @ 3:26 AM
Study NCT ID:
NCT04679428
Status:
UNKNOWN
Last Update Posted:
2020-12-22
First Post:
2020-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunological Characteristics of COVID-19 Patients
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2023-05-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-21', 'studyFirstSubmitDate': '2020-12-21', 'studyFirstSubmitQcDate': '2020-12-21', 'lastUpdatePostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunological changes during and after COVID-19 infection', 'timeFrame': 'July 2022', 'description': 'Correlation between TBNK dynamic and increase of neutralising antibodies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'SARS-CoV-2', 'immunology', 'TBNK Cells', 'neutralizing antibodies'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The study will look at the immunological characteristics of COVID-19 patients and determine neutralizing antibodies against SARS-CoV-2 virus.', 'detailedDescription': "The immunogram (quantitative TBNK immunophenotipisation) will be performed by flow cytometry, the antibody response will be determined by IVD ELISa.\n\nClinical biochemical and immunochemical (ECLIA) tests (including IL-6) will be performed on Cobas analyzers. Hemogram with differential blood picture will be performed with a hematology analyzer Sysmex XN 3100, examination of blood smears with CellaVision system or. microscope. Coagulation tests will be performed on BCS XP analyzers.\n\nAn in-house system for the analysis of SARS-CoV-2 virus fusion inhibitors on human cells will be used to detect the ability of antibodies from patients' serum to neutralize the virus and thus potential protection against re-infection. The system is quantitative, meaning that the titer of such antibodies could be determined, and thus the potential level of protection would be evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COVID-19 patients recruited at University Clinic of Pulmonary and Allergic Diseases Golnik.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nProvide written consent before being included in the essay.\n\nPositive cases of COVID-19 (based on polymerase chain reaction or positive antigen test for SARS-CoV-2).\n\nExclusion Criteria:\n\nPatients who are unable to give consent or who are unable to follow up will be excluded.'}, 'identificationModule': {'nctId': 'NCT04679428', 'briefTitle': 'Immunological Characteristics of COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'The University Clinic of Pulmonary and Allergic Diseases Golnik'}, 'officialTitle': 'Immunological Characteristics of COVID-19 Patients and Determination of Neutralizing Antibodies Against SARS-CoV-2 Virus', 'orgStudyIdInfo': {'id': 'Golnik_Covid-19'}}, 'contactsLocationsModule': {'locations': [{'zip': '4204', 'city': 'Golnik', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Peter Korošec, PhD', 'role': 'CONTACT', 'email': 'peter.korosec@klinika-golnik.si', 'phone': '4 25 69 432', 'phoneExt': '+386'}, {'name': 'Peter Korošec, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Barbara Bitežnik, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aleš Rozman, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Matjaž Fležar, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katarina Osolnik, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Petra Svetina, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vesna Nikolić, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Peter Kopač, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tomaž Hafner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tina Jerič, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nina Frelih, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mojca Bizjak, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kristina Cerk Porenta, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rok Lombar, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katja Adamič, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katja Mohorčič, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sanja Grm Zupan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tanja Šubic, M.Sc. Nursing', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Izidor Kern, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mile Kovačevič, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gregor Vlačić, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pika Meško Brguljan, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Urška Bidovec Stojkovič, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Matija Rijavec, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ana Koren, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ajda Demšar, MsC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Clinic of Respiratory and Allergic Diseases Golnik', 'geoPoint': {'lat': 46.33333, 'lon': 14.33333}}], 'centralContacts': [{'name': 'Peter Korošec, PhD', 'role': 'CONTACT', 'email': 'peter.korosec@klinika-golnik.si', 'phone': '042569432', 'phoneExt': '+386'}, {'name': 'Gregor Ostanek', 'role': 'CONTACT', 'email': 'gregor.ostanek@klinika-golnik.si', 'phone': '42569500', 'phoneExt': '+386'}], 'overallOfficials': [{'name': 'Peter Korošec, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of the Laboratory for Clinical Immunology and Molecular Genetics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University Clinic of Pulmonary and Allergic Diseases Golnik', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Chemistry, Slovenia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof Peter Korošec, BSc (Biol), PhD', 'investigatorFullName': 'Peter Korošec', 'investigatorAffiliation': 'The University Clinic of Pulmonary and Allergic Diseases Golnik'}}}}