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

NCT04544033 | Completed DMC

• 1 other identifier: IL6 in egyptian COVID patients
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• interleukin 6 level

  "through study completion, an average of 4 months

Study Arms (3)

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; Diagnostic Test: Interleukin-6 Gene-174C detection

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; Diagnostic Test: Interleukin-6 Gene-174C detection

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; Diagnostic Test: Interleukin-6 Gene-174C detection

Interventions

interleuken 6 level measurment DIAGNOSTIC_TEST

Detection of IL6 level using ELISA technique.

mild group; moderate group; severe group

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.

mild group; moderate group; severe group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Bsant Safwat Kasem

Tanta, El Gharbyia, 31527, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood sample will be collected on EDTA containing tubes. Peripheral blood sample will be collected on plain tube

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: September 10, 2020
• Study Start: September 15, 2020
• Primary Completion: March 15, 2022
• Study Completion: May 1, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-05

Locations

EG (1)