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

NCT ID: NCT04544033

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2022-05-01

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

Conditions

Covid19

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

interleuken 6 level measurment

Intervention Type: DIAGNOSTIC_TEST

Detection of IL6 level using ELISA technique.

Interleukin-6 Gene-174C detection

Intervention Type: DIAGNOSTIC_TEST

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).

interleuken 6 level measurment

Intervention Type: DIAGNOSTIC_TEST

Detection of IL6 level using ELISA technique.

Interleukin-6 Gene-174C detection

Intervention Type: DIAGNOSTIC_TEST

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).

interleuken 6 level measurment

Intervention Type: DIAGNOSTIC_TEST

Detection of IL6 level using ELISA technique.

Interleukin-6 Gene-174C detection

Intervention Type: DIAGNOSTIC_TEST

The genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique.

Interventions

interleuken 6 level measurment

Detection of IL6 level using ELISA technique.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

bsant safwat kasem

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bsant Safwat Kasem

Tanta, El Gharbyia, Egypt

Countries

Egypt

Other Identifiers

IL6 in egyptian COVID patients

Identifier Type: -

Identifier Source: org_study_id