Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-31 @ 9:29 PM
Study NCT ID:
NCT04544033
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2020-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IL- 6 Gene (174G/C) Single Nucleotide Polymorphism as an Indicator of COVID-19 Severity in Egyptian 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_WITH_DNA', 'description': 'Peripheral blood sample will be collected on EDTA containing tubes. Peripheral blood sample will be collected on plain tube'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-01', 'studyFirstSubmitDate': '2020-09-05', 'studyFirstSubmitQcDate': '2020-09-09', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'interleuken- 6 gene (174G/C) single nucleotide polymorphism', 'timeFrame': '"through study completion, an average of 4 months', 'description': 'the correlation between IL- 6 gene (174G/C) single nucleotide polymorphism with the pathogenesis of COVID-19 severity in Egyptian patients.'}], 'secondaryOutcomes': [{'measure': 'interleukin 6 level', 'timeFrame': '"through study completion, an average of 4 months', 'description': 'the correlation between IL-6 with the pathogenesis of COVID-19 severity in Egyptian patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Although the direct damage from the viruses contributes to the initiation of the disease, the cytokine storm caused by COVID-19 plays a vital role in the development of acute lung injury and adult respiratory distress syndrome. IL-6, a kind of pleiotropic cytokine, is expressed by immune cells such as DC, monocytes, macrophages, B cells, and subsets of activated T cells, as well as by non-immune cells like fibroblasts, epithelial cells, and keratinocytes', 'detailedDescription': 'The World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern the epidemic has put public health systems under severe strain both in western countries and in the developing world. SARS-CoV-2 displays a more efficient transmission pattern when compared with SARS-CoV and MERS-CoV. Although the direct damage from the viruses contributes to the initiation of the disease, the cytokine storm caused by COVID-19 plays a vital role in the development of acute lung injury and adult respiratory distress syndrome.\n\nIL-6, a kind of pleiotropic cytokine, is expressed by immune cells such as DC, monocytes, macrophages, B cells, and subsets of activated T cells, as well as by non-immune cells like fibroblasts, epithelial cells, and keratinocytes. It contributes to the pathogenesis of inflammatory or autoimmunity diseases. Excessive production of IL-6 leads to serious disease progression in viral infection. The IL-6 gene is located on chromosome 7 and several polymorphisms have been reported. The most frequently studied polymorphism is the single nucleotide polymorphism (SNP) 174C and - 174G in the promoter region, which has been associated with transcription rates of IL6. The incidence of IL-6-174C alleles is approximately 40%among the general Population. The G allele 174 SNP is coupled with the increased transcription upon endotoxin and IL-1β stimulation, IL-6 -174C allele carrier status is associated with higher level of IL-6 production and more severe forms of 4 pneumonia in general. This analysis strengthens the notion that IL-6 plays a pivotal role in novel coronavirus pneumonia (NCP) progression, it was IL-6-174 C allele rather than G allele that contributed to the risk of sepsis induced by Pneumonia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients proved to be COVID-19 positive by clinical correlation with positive PCR or rapid antigen detection test.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients proved to be COVID-19 positive\n* clinical correlation with positive PCR.\n* clinical correlation with positive rapid antigen detection test.\n\nExclusion Criteria:\n\n* Patients with chronic infections including hepatitis B or C infection.\n* Immunodeficiency virus (HIV) infections.\n* Autoimmune diseases including systemic lupus erthromatosus and rheumatoid arthritis.\n* Any malignancy or chronic inflammation\n* Any other chest diseases (TB)'}, 'identificationModule': {'nctId': 'NCT04544033', 'briefTitle': 'IL- 6 Gene (174G/C) Single Nucleotide Polymorphism as an Indicator of COVID-19 Severity in Egyptian Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'IL- 6 Gene (174G/C) Single Nucleotide Polymorphism as an Indicator of COVID-19 Severity in Egyptian Patients', 'orgStudyIdInfo': {'id': 'IL6 in egyptian COVID patients'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mild group', 'description': 'Amendment to MOH COVID-19 Protocol:\n\n* Patient with mild clinical symptoms \\& clinically table.\n* CT changes: Appearance in the lung from no changes to just subpleural nodule or subpleural line.', 'interventionNames': ['Diagnostic Test: interleuken 6 level measurment', 'Diagnostic Test: Interleukin-6 Gene-174C detection']}, {'label': 'moderate group', 'description': 'Amendment to MOH COVID-19 Protocol:\n\n* Patient with non-specific and specific respiratory infection (pneumonia).\n* CT changes in both lungs (Ground glass opacities (GGO), Crazy paving, consolidation, multiple interlobular thickening).', 'interventionNames': ['Diagnostic Test: interleuken 6 level measurment', 'Diagnostic Test: Interleukin-6 Gene-174C detection']}, {'label': 'severe group', 'description': 'Amendment to MOH COVID-19 Protocol:\n\n* Patients with respiratory distress (RR \\> 30/min, Sa02 \\< 92 at room air).\n* Chest radiology showing more than 50% lesion or progressive lesion within 24 to 48 hours.\n* CT changes in both lungs: extensive (GGO, Crazy paving, consolidation, multiple interlobular thickening, fan shaped distribution of peribronchial thickening).', 'interventionNames': ['Diagnostic Test: interleuken 6 level measurment', 'Diagnostic Test: Interleukin-6 Gene-174C detection']}], 'interventions': [{'name': 'interleuken 6 level measurment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Detection of IL6 level using ELISA technique.', 'armGroupLabels': ['mild group', 'moderate group', 'severe group']}, {'name': 'Interleukin-6 Gene-174C detection', 'type': 'DIAGNOSTIC_TEST', 'description': 'The genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique.', 'armGroupLabels': ['mild group', 'moderate group', 'severe group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El Gharbyia', 'country': 'Egypt', 'facility': 'Bsant Safwat Kasem', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'bsant safwat kasem', 'investigatorAffiliation': 'Tanta University'}}}}