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Completed

NCT Number: NCT04544033

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

interleuken 6 level measurment

Diagnostic Test

Detection of IL6 level using ELISA technique.

Interleukin-6 Gene-174C detection

Diagnostic Test

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

Primary outcomes

  1. interleuken- 6 gene (174G/C) single nucleotide polymorphism

    Time frame: "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 outcomes

  1. interleukin 6 level

    Time frame: "through study completion, an average of 4 months

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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2020
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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