Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT04766294
Status:
COMPLETED
Last Update Posted:
2021-06-24
First Post:
2021-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Macrophage Activation Markers in 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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-22', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-02-21', 'lastUpdatePostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of matrix metalloproteinase-7 "MMP-7" serum level (pg/ml) as a biomarker of macrophage activation', 'timeFrame': 'MMP-7 is measured after admission of patients to isolation hospital along 7 days interval for 21 days, 3 plasma samples are collected on the 7th day of admission, day 14 and day 21', 'description': 'ELISA "Enzyme linked immunosorbent assay" technique.'}, {'measure': 'Measurement of matrix metalloproteinase-9 "MMP-9" serum level (pg/L) as a biomarker of macrophage activation', 'timeFrame': 'MMP-9 is measured after admission of patients to isolation hospital along 7 days interval for 21 days, 3 plasma samples are collected on the 7th day of admission, day 14 and day 21', 'description': 'ELISA "Enzyme linked immunosorbent assay" technique.'}, {'measure': 'Measurement of transforming growth factor B "TGF-B" serum level ( pg/ml) as a biomarker of macrophage activation', 'timeFrame': 'TGF-B is measured after admission of patients to isolation hospital along 7 days interval for 21 days, 3 plasma samples are collected on the 7th day of admission, day 14 and day 21', 'description': 'ELISA "Enzyme linked immunosorbent assay" technique.'}, {'measure': 'Measurement of platelet derived growth factor "PDGF" serum level (ng/ml) as a biomarker of macrophage activation', 'timeFrame': 'PDGF is measured after admission of patients to isolation hospital along 7 days interval for 21 days, 3 plasma samples are collected on the 7th day of admission, day 14 and day 21', 'description': 'ELISA "Enzyme linked immunosorbent assay" technique.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This study is aiming to find the relation between the severity of COVID-19 in diabetic and obese patients and the high serum levels of matrix metalloproteinase-7 (MMP-7),matrix metalloproteinase-9 (MMP-9), TGF-β and PDGF Macrophage Activation Markers', 'detailedDescription': 'Acute respiratory distress syndrome (ARDS) commonly occurs in COVID-19 patients who are diabetic and obese, ARDS is characterized by inflammation and pulmonary fibrosis mediated by cytokines and biomarkers released from activated alveolar macrophages, also cytokine storm may occurs leading to multiple organ failure. These sequelae of COVID-19 disease in obese and diabetic patients are attributed to elevated plasma lipopolysaccharide which is the main activator of M1 and M2 macrophages. chronic activation of macrophages leads to production of profibrotic markers as transforming growth factor-β (TGF-β), platelet-derived growth factor (PDGF), matrix metalloproteinase-7 (MMP7) and matrix metalloproteinase-9 (MMP9) which promote fibrogenesis. In this research, we measure circulatory alveolar macrophage activation markers in COVID-19 obese patients with type 1 and type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'COVID-19 patients admitted to isolation hospital in Sohag "Sohag teaching hospital".', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight patients with body mass index higher than 25 and obese patients with body mass index higher than 30 were selected to be included\n* Type one and type two diabetes mellitus patients were also included\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04766294', 'acronym': 'COVID-19', 'briefTitle': 'Macrophage Activation Markers in COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Is the Severity of COVID-19 in Obese and Diabetic Patients Linked to High Serum Levels of MMP-7, MMP-9, TGF-β and PDGF Macrophage Activation Markers?', 'orgStudyIdInfo': {'id': 'Soh-Med-21-02-20'}}, 'contactsLocationsModule': {'locations': [{'zip': '82524', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Faculty of medicine - sohag university', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Nahed Fathallah, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of Medical Microbiology & Immunology department -Faculty of medicine- Sohag university', 'investigatorFullName': 'Nahed Fathallah Fahmy', 'investigatorAffiliation': 'Sohag University'}}}}