Covid19NCT04544033
IL- 6 Gene (174G/C) Single Nucleotide Polymorphism as an Indicator of COVID-19 Severity in Egyptian Patients
An observational study of Covid19, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- interleuken 6 level measurment and Interleukin-6 Gene-174C detection
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2020to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients proved to be COVID-19 positive by clinical correlation with positive PCR or rapid antigen detection test.
Who may be able to join
- Patients proved to be COVID-19 positive
- clinical correlation with positive PCR.
- clinical correlation with positive rapid antigen detection test.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- interleuken 6 level measurment, Interleukin-6 Gene-174C detection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interleuken 6 level measurmentDiagnostic test
Detection of IL6 level using ELISA technique.
Interleukin-6 Gene-174C detectionDiagnostic test
The genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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). Receives: Diagnostic Test: interleuken 6 level measurment; Diagnostic Test: Interleukin-6 Gene-174C detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "through study completion, an average of 4 months
Secondary outcomes (1)
interleukin 6 level
the correlation between IL-6 with the pathogenesis of COVID-19 severity in Egyptian patients.
Measured: "through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start15 Sep 2020
- Primary completion15 Mar 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bsant safwat kasem, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544033
- Sponsor's protocol ID
- IL6 in egyptian COVID patients
- Status last verified
- May 2022
- First submitted
- 5 Sep 2020
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IL- 6 Gene (174G/C) Single Nucleotide Polymorphism as an Indicator of COVID-19 Severity in Egyptian Patients
- ClinicalTrials.gov ID
- NCT04544033
- Acronym / sponsor ID
- IL6 in egyptian COVID patients
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild group | – | Diagnostic Test: interleuken 6 level measurment, Diagnostic Test: Interleukin-6 Gene-174C detectionAmendment 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. |
| moderate group | – | Diagnostic Test: interleuken 6 level measurment, Diagnostic Test: Interleukin-6 Gene-174C detectionAmendment 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). |
| severe group | – | Diagnostic Test: interleuken 6 level measurment, Diagnostic Test: Interleukin-6 Gene-174C detectionAmendment 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients proved to be COVID-19 positive by clinical correlation with positive PCR or rapid antigen detection test.
Key inclusion criteria (3 listed)
- Patients proved to be COVID-19 positive
- clinical correlation with positive PCR.
- clinical correlation with positive rapid antigen detection test.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interleuken 6 level measurmentDetection of IL6 level using ELISA technique. | Diagnostic test | mild group, moderate group, severe group |
| Interleukin-6 Gene-174C detectionThe genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique. | Diagnostic test | mild group, moderate group, severe group |
Primary outcome
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.
1 secondary outcome
interleukin 6 level
Time frame: "through study completion, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interleuken- 6 gene (174G/C) single nucleotide polymorphism (time frame: "through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022; AzTrials last refreshed its copy on 30 Oct 2026.