Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-30 @ 11:44 AM
Study NCT ID:
NCT04824495
Status:
UNKNOWN
Last Update Posted:
2021-04-06
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Inflammatory Cytokines During COVID-19
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-04', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytokine level in context with clinical parameters', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '39472409', 'type': 'DERIVED', 'citation': 'Antoniewicz L, Melnikov G, Lyytinen G, Blomberg A, Bosson JA, Hedman L, Mobarrez F, Lundback M. Vascular Stress Markers Following Inhalation of Heated Tobacco Products: A Study on Extracellular Vesicles. Cardiovasc Toxicol. 2025 Jan;25(1):1-8. doi: 10.1007/s12012-024-09934-6. Epub 2024 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate pro-inflammatory cytokines as well as microvesicles during the course of SARS-CoV2 infection in the context of clinical parameters.', 'detailedDescription': 'In this prospective trial, 100 patients with an acute SARS-CoV2 infection are enrolled. After confirmation of COVID-19, blood samples are taken for evaluation of various inflammatory cyokines and microvesicles at day 1, 5, 9 and 13 during hospitalisation and are interpreted in the context of clinical parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with confirmed acute SARS-CoV2 infection', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Confirmation of acute SARS-CoV2 infection\n* Ability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04824495', 'briefTitle': 'Evaluation of Inflammatory Cytokines During COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Vienna'}, 'officialTitle': 'Evaluation of Inflammatory Cytokines During COVID-19', 'orgStudyIdInfo': {'id': 'Version 1.1, 31.12.2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with acute COVID-19', 'interventionNames': ['Diagnostic Test: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood samples at different timepoints during SARS-CoV2 infection', 'armGroupLabels': ['Patients with acute COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Daniela Gompelmann', 'role': 'CONTACT', 'email': 'daniela.gompelmann@meduniwien.ac.at', 'phone': '0043 1 40400 47730'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Daniela Gompelmann', 'role': 'CONTACT', 'email': 'daniela.gompelmann@meduniwien.ac.at', 'phone': '0043 1 40400 47730'}], 'overallOfficials': [{'name': 'Daniela Gompelmann', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Daniela Gompelmann', 'investigatorAffiliation': 'University of Vienna'}}}}