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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: interleuken 6 level measurment
* Diagnostic Test: Interleukin-6 Gene-174C detection


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mild group<br>Amendment 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. | Diagnostic Test: interleuken 6 level measurment<br>* Detection of IL6 level using ELISA technique.<br>Diagnostic Test: Interleukin-6 Gene-174C detection<br>* The genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique.<br>|
| moderate group<br>Amendment 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). | Diagnostic Test: interleuken 6 level measurment<br>* Detection of IL6 level using ELISA technique.<br>Diagnostic Test: Interleukin-6 Gene-174C detection<br>* The genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique.<br>|
| severe group<br>Amendment 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). | Diagnostic Test: interleuken 6 level measurment<br>* Detection of IL6 level using ELISA technique.<br>Diagnostic Test: Interleukin-6 Gene-174C detection<br>* The genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interleuken- 6 gene (174G/C) single nucleotide polymorphism | the correlation between IL- 6 gene (174G/C) single nucleotide polymorphism with the pathogenesis of COVID-19 severity in Egyptian patients. | through study completion, an average of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interleukin 6 level | the correlation between IL-6 with the pathogenesis of COVID-19 severity in Egyptian patients. | through study completion, an average of 4 months |