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IL- 6 Gene (174G/C) Single Nucleotide Polymorphism as an Indicator of COVID-19 Severity in Egyptian Patients

Completed
Conditions
Covid19
Interventions
Diagnostic Test: interleuken 6 level measurment
Diagnostic Test: Interleukin-6 Gene-174C detection
Registration Number
NCT04544033
Lead Sponsor
Tanta University
Brief Summary

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

Detailed Description

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.

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. 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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
Inclusion Criteria
  • Patients proved to be COVID-19 positive
  • clinical correlation with positive PCR.
  • clinical correlation with positive rapid antigen detection test.
Exclusion Criteria
  • Patients with chronic infections including hepatitis B or C infection.
  • Immunodeficiency virus (HIV) infections.
  • Autoimmune diseases including systemic lupus erthromatosus and rheumatoid arthritis.
  • Any malignancy or chronic inflammation
  • Any other chest diseases (TB)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
moderate groupinterleuken 6 level measurmentAmendment to MOH COVID-19 Protocol: * Patient with non-specific and specific respiratory infection (pneumonia). * CT changes in both lungs (Ground glass opacities (GGO), Crazy paving, consolidation, multiple interlobular thickening).
mild groupinterleuken 6 level measurmentAmendment to MOH COVID-19 Protocol: * Patient with mild clinical symptoms \& clinically table. * CT changes: Appearance in the lung from no changes to just subpleural nodule or subpleural line.
mild groupInterleukin-6 Gene-174C detectionAmendment to MOH COVID-19 Protocol: * Patient with mild clinical symptoms \& clinically table. * CT changes: Appearance in the lung from no changes to just subpleural nodule or subpleural line.
severe groupInterleukin-6 Gene-174C detectionAmendment to MOH COVID-19 Protocol: * Patients with respiratory distress (RR \> 30/min, Sa02 \< 92 at room air). * Chest radiology showing more than 50% lesion or progressive lesion within 24 to 48 hours. * CT changes in both lungs: extensive (GGO, Crazy paving, consolidation, multiple interlobular thickening, fan shaped distribution of peribronchial thickening).
moderate groupInterleukin-6 Gene-174C detectionAmendment to MOH COVID-19 Protocol: * Patient with non-specific and specific respiratory infection (pneumonia). * CT changes in both lungs (Ground glass opacities (GGO), Crazy paving, consolidation, multiple interlobular thickening).
severe groupinterleuken 6 level measurmentAmendment to MOH COVID-19 Protocol: * Patients with respiratory distress (RR \> 30/min, Sa02 \< 92 at room air). * Chest radiology showing more than 50% lesion or progressive lesion within 24 to 48 hours. * CT changes in both lungs: extensive (GGO, Crazy paving, consolidation, multiple interlobular thickening, fan shaped distribution of peribronchial thickening).
Primary Outcome Measures
NameTimeMethod
interleuken- 6 gene (174G/C) single nucleotide polymorphism"through study completion, an average of 4 months

the correlation between IL- 6 gene (174G/C) single nucleotide polymorphism with the pathogenesis of COVID-19 severity in Egyptian patients.

Secondary Outcome Measures
NameTimeMethod
interleukin 6 level"through study completion, an average of 4 months

the correlation between IL-6 with the pathogenesis of COVID-19 severity in Egyptian patients.

Trial Locations

Locations (1)

Bsant Safwat Kasem

🇪🇬

Tanta, El Gharbyia, Egypt

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