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

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

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: interleuken 6 level measurment; Diagnostic test: Interleukin-6 Gene-174C detection

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

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Egypt
  • El Gharbyia
    • Tanta, El Gharbyia, Egypt, 31527
      • Bsant Safwat Kasem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients proved to be COVID-19 positive by clinical correlation with positive PCR or rapid antigen detection test.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mild group; 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; Detection of IL6 level using ELISA technique.; Diagnostic test: Interleukin-6 Gene-174C detection; The genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique.
moderate group; 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; Detection of IL6 level using ELISA technique.; Diagnostic test: Interleukin-6 Gene-174C detection; The genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique.
severe group; 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; Detection of IL6 level using ELISA technique.; Diagnostic test: Interleukin-6 Gene-174C detection; The genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: September 5, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 1, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IL6 in egyptian COVID patients

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No