Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-27 @ 7:32 PM
Study NCT ID:
NCT04784468
Status:
UNKNOWN
Last Update Posted:
2021-03-09
First Post:
2021-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DNA Damage and Oxidative Stress in Hospitalized COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2021-03-03', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DNA damage', 'timeFrame': 'Baseline', 'description': 'Compare DNA damage (% of DNA in the tail; measured by the comet assay) between hospitalized COVID-19 patients to influenza patients and healthy controls.'}], 'secondaryOutcomes': [{'measure': 'The investigators will consider further DNA damage parameter', 'timeFrame': 'Baseline', 'description': 'Compare other DNA damage endpoints measured with the comet assay (i.e. tail length, tail moment and damage index) between hospitalized COVID-19 patients to influenza patients and healthy controls.'}, {'measure': 'The investigators will consider oxidative stress marker', 'timeFrame': 'Baseline', 'description': 'Compare oxidative stress biomarker malondialdehyde, FRAP, GSH, GSSG (all µmol/L) and the ration GSH/GSSG between hospitalized COVID-19 patients to influenza patients and healthy controls.'}, {'measure': 'The investigators will consider inflammatory marker', 'timeFrame': 'Baseline', 'description': 'Compare inflammatory marker Interleukin 1 (IL-1), IL-6, IL-8, IL-10, TNF-alpha (all rfU) and CRP (mg/dl) between hospitalized COVID-19 patients to influenza patients and healthy controls.'}, {'measure': 'The investigators will consider the phenotypic age marker', 'timeFrame': 'Baseline', 'description': 'Compare the phenotypic age marker between hospitalized COVID-19 patients to influenza patients and healthy controls.'}, {'measure': 'The investigators will consider RDA and DNA gene expression', 'timeFrame': 'Baseline', 'description': 'Compare RNA and DNA gene expression between hospitalized COVID-19 patients to influenza patients and healthy controls.'}, {'measure': 'The investigators will consider clinical biochemistry marker', 'timeFrame': 'Baseline', 'description': 'Compare clinical biochemistry (Total cholesterol (mg/dl), LDL-cholesterol (mg/dl), triglycerides (mg/dl), blood glucose (mg/dl), uric acid (mg/dl)) between hospitalized COVID-19 patients to influenza patients and healthy controls.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DNA damage', 'Oxidative Stress', 'Inflammation'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the coronavirus disease 2019 (COVID-19) pandemic challenging health systems worldwide.\n\nWhile there is a clear correlation between oxidative stress markers and the severity of many viral diseases such as hepatitis C, for SARS-CoV clinical data is limited.\n\nThe investigators aim at 1.) investigating DNA damage, oxidative stress, inflammation, and aging markers in COVID-19 patients and compare them with age and gender matched healthy controls and patients with influenza; and 2.) investigating all aforementioned parameters during "cytokine storm" via repeated blood sampling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Covid 19 patients:\n\nCases after hospital admission.\n\nInfluenza:\n\nCases after confirmed influenza diagnosis\n\nHealthy controls:\n\nHealthy subjects from the general population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Covid 19 group:\n\nInclusion Criteria:\n\n* gender: female/male\n* age: ≥40 years\n* patients admitted at the emergency department\n* COVID-19 suspected patients\n* able to give written informed consent\n\nExclusion Criteria:\n\n* children (≤ 18 years) and adults 19-39 years\n* not hospitalized, but confirmed COVID-19 patients (outpatients)\n* patients without definitive COVID-19 confirmation\n\nControl group:\n\nInclusion criteria:\n\n* gender: female/male\n* age: ≥40 years\n* absence of severe illnesses/serious diseases\n* able to give written informed consent\n\nExclusion criteria:\n\n* children (≤ 18 years) and adults 19-39years\n* any current or past clinically significant pathology/disease (comorbidity) such as:\n\n * Malignancies\n * Cardiovascular diseases\n * Diabetes mellitus (I and II)\n * Obesity class III (BMI \\>40)\n * Other severe diseases (e.g. renal, hepatic, thyroid disease, bone metabolic diseases, rheumatoid osteoarthritis, human immunodeficiency syndrome, …)\n\nInfluenza group:\n\nInclusion criteria:\n\n* gender: female/male\n* age: ≥40 years\n* patients admitted at the emergency department\n* influenza suspected patients\n* able to give written informed consent\n\nExclusion criteria:\n\n* children (≤ 18 years) and adults 19-39 years\n* patients without definitive influenza confirmation'}, 'identificationModule': {'nctId': 'NCT04784468', 'acronym': 'ABCD', 'briefTitle': 'DNA Damage and Oxidative Stress in Hospitalized COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Vienna'}, 'officialTitle': 'DNA Damage and Oxidative Stress in Hospitalized COVID-19 Patients Compared to Healthy Controls: A Case-control Study', 'orgStudyIdInfo': {'id': 'UNIVIE_Covid_Oxstress'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Covid-19', 'description': 'Covid-19 patients', 'interventionNames': ['Other: No intervention']}, {'label': 'Influenza', 'description': 'Influenza patients', 'interventionNames': ['Other: No intervention']}, {'label': 'Cotrol', 'description': 'Control group', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Case-control design, one single investigation', 'armGroupLabels': ['Cotrol', 'Covid-19', 'Influenza']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1220', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Rainer Thell, MD', 'role': 'CONTACT', 'email': 'rainer.thell@wienkav.at', 'phone': '+43 67683112550'}], 'facility': 'Klinik Donaustadt', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Karl-Heinz Wagner, PhD', 'role': 'CONTACT', 'email': 'karl-heinz.wagner@univie.ac.at', 'phone': '+4314277', 'phoneExt': '54930'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vienna', 'class': 'OTHER'}, 'collaborators': [{'name': 'SMZ-Ost Donauspital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Human Nutrition', 'investigatorFullName': 'Wagner Karl-Heinz', 'investigatorAffiliation': 'University of Vienna'}}}}