Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-01 @ 5:14 PM
Study NCT ID:
NCT05145751
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2021-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SARS CoV-2 Infection and Inflammatory Biomarkers
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016133', 'term': 'Polymerase Chain Reaction'}], 'ancestors': [{'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-01', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcome', 'timeFrame': '1 year', 'description': 'Outcome after COVID-19 infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Biomarkers', 'Inflammation'], 'conditions': ['COVID-19', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'Early research suggests that inflammation plays a key role in the development of SARS CoV-2 infection. The immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. This study ought to investigate the association of simple biomarkers such as NLR and PLR with the clinical outcome in SARS CoV-2 infection patients.', 'detailedDescription': "Early research suggests that inflammation plays a key role in the development of SARS CoV-2 infection. The immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. Moreover, previous studies have demonstrated that a sustained release of anti-inflammatory cytokines may lead to high levels of circulating neutrophils and lymphocytes' apoptosis with subsequent lymphopenia and immune response imbalance. Therefore, circulating biomarkers that represent inflammation and immune status could serve as potential predictors for the prognosis of SARS CoV-2 patients. The neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) are cheap and simply calculated biomarkers which have been identified as markers of systemic inflammation, severity of the disease and prognosis in several patient populations.\n\nThis study ought to investigate the association of simple biomarkers such as NLR and PLR with the clinical outcome in SARS CoV-2 infection patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with SARS CoV-2 infection who were treated by the Department of Respiratory Medicine in the UHL will be done. The subjects will be followed from admission to the hospital and up until discharge, transfer to the ICU or death', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection\n\nExclusion Criteria:\n\n* Patients aged\\<18 years'}, 'identificationModule': {'nctId': 'NCT05145751', 'briefTitle': 'SARS CoV-2 Infection and Inflammatory Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'officialTitle': 'SARS CoV-2 Infection and Simple Inflammatory Biomarkers.', 'orgStudyIdInfo': {'id': '46937'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 infection', 'description': 'Consecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection', 'interventionNames': ['Other: Simple inflammatory biomarkers measurement']}], 'interventions': [{'name': 'Simple inflammatory biomarkers measurement', 'type': 'OTHER', 'otherNames': ['Consecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection'], 'description': 'In patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection the values of simple inflammatory biomarkers such NLR will be measured', 'armGroupLabels': ['COVID-19 infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41110', 'city': 'Larissa', 'state': 'Thessaly', 'country': 'Greece', 'facility': 'Univeristy of Thessaly', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}], 'overallOfficials': [{'name': 'Eleni Arnaoutoglou, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Study Chair'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Thessaly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Elena Arnaoutoglou', 'investigatorAffiliation': 'University of Thessaly'}}}}