COVID-19 Respiratory InfectionCOVID 19IL17NCT04948515
Gene Polymorphism of IL17 and IL 23
An observational study of COVID-19 Respiratory Infection, run by Sohag University at 1 site in Egypt.
Trial summary
rates are in such considerable amount among large population base. The pathogenesis of COVID-19 implicates a potent inflammatory response, involving a complex group of mediators including interleukins. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- laboratory test
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2021to 3 Dec 2021
- How long will I take part?
- 4 Months
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: group 1 patients with covid 19 with severe infections admitted at ICU group 2 patients with covid 19 with nonsevere infections admitted at internal wards
Who may be able to join
- Patients with Covid19 positive PCR
Who cannot join
- Patients with Covid19 clinical criteria not confirmed by PCR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Gene Polymorphism of IL17 and IL 23 in Patients With COVID 19
rates are in such considerable amount among large population base. The pathogenesis of COVID-19 implicates a potent inflammatory response, involving a complex group of mediators including interleukins. These pleiotropic cytokines are secreted at the region of inflammation and released into the circulation by a variety of different cell types, including macrophages, lymphocytes, endothelial cells, epithelial cells during sepsis and acute organ injuries. There has recently found a number of studies reporting that the cytokine storms take part in the course of COVID-19
Read the detailed description
Aim Of The Study
- To evaluate if there is an association between the IL-17, IL-23 gene polymorphism in Patients With COVID 19 by real-time PCR
- To measure the serum level of IL17 by ELISA in COVID 19 patients by ELISA.
- To detect if there is an association between gene polymorphism of IL17 and IL23 and severity of a condition in patients with COVID 19 Study design: a cross-sectional study.
The blood samples will be collected from patient records in COVID19 isolation hospitals in sohag governorate and isolation department in sohag university hospitals.
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- laboratory test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory testDiagnostic test
genotyping of IL 17 and IL23
laboratory testDiagnostic test
estimation of serum level of IL 17
| Study group | Role | What they receive |
|---|---|---|
| group 1 patients with severe covid 19 respiratory infections | Patients with severe covid 19 admitted to ICU, blood samples will be collected for testing different genotypes and serum level of IL 17 Receives: Diagnostic Test: laboratory test | |
| group 2 patients with non severe covid 19 respiratory infections | Patients with nonsevere covid 19 admitted to the internal ward, blood samples will be collected for testing different genotypes and serum level of IL 17 Receives: Diagnostic Test: laboratory test |
What is being measured
The primary outcome is the main question the study is designed to answer.
genotyping of IL 17
real time pcr detection of different genotypes
Measured: 3-6-2021 to 30-8-2021
genotyping of IL 23
real time pcr detection of different genotypes
Measured: 3-6-2021 to 30-8-2021
estimation of serum level of IL 17
measuring serum level of IL 17 by ELISA
Measured: 3-6-2021 to 30-8-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start3 Jun 2021
- Primary completion30 Nov 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Saber Shafik, Sohag University
- Investigators
- N S shafik, lecturer, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948515
- Sponsor's protocol ID
- Soh-Med-21-04-35
- Acronym
- COVID 19IL17
- Status last verified
- Oct 2022
- First submitted
- 24 Jun 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to protect the privacy of the patient
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Gene Polymorphism of IL17 and IL 23 in Patients With COVID 19
- ClinicalTrials.gov ID
- NCT04948515
- Acronym / sponsor ID
- COVID 19IL17 / Soh-Med-21-04-35
- Conditions
- COVID-19 Respiratory Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 2 Jul 2021 (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.
rates are in such considerable amount among large population base. The pathogenesis of COVID-19 implicates a potent inflammatory response, involving a complex group of mediators including interleukins. These pleiotropic cytokines are secreted at the region of inflammation and released into the circulation by a variety of different cell types, including macrophages, lymphocytes, endothelial cells, epithelial cells during sepsis and acute organ injuries. There has recently found a number of studies reporting that the cytokine storms take part in the course of COVID-19
Detailed description
Aim Of The Study
- To evaluate if there is an association between the IL-17, IL-23 gene polymorphism in Patients With COVID 19 by real-time PCR
- To measure the serum level of IL17 by ELISA in COVID 19 patients by ELISA.
- To detect if there is an association between gene polymorphism of IL17 and IL23 and severity of a condition in patients with COVID 19 Study design: a cross-sectional study.
The blood samples will be collected from patient records in COVID19 isolation hospitals in sohag governorate and isolation department in sohag university hospitals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 patients with severe covid 19 respiratory infections | – | Diagnostic Test: laboratory testPatients with severe covid 19 admitted to ICU, blood samples will be collected for testing different genotypes and serum level of IL 17 |
| group 2 patients with non severe covid 19 respiratory infections | – | Diagnostic Test: laboratory testPatients with nonsevere covid 19 admitted to the internal ward, blood samples will be collected for testing different genotypes and serum level of IL 17 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- group 1 patients with covid 19 with severe infections admitted at ICU group 2 patients with covid 19 with nonsevere infections admitted at internal wards
Key inclusion criteria (1 listed)
- Patients with Covid19 positive PCR
Key exclusion criteria (1 listed)
- Patients with Covid19 clinical criteria not confirmed by PCR
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 |
|---|---|---|
| laboratory testgenotyping of IL 17 and IL23 | Diagnostic test | group 1 patients with severe covid 19 respiratory infections, group 2 patients with non severe covid 19 respiratory infections |
| laboratory testestimation of serum level of IL 17 | Diagnostic test | group 1 patients with severe covid 19 respiratory infections, group 2 patients with non severe covid 19 respiratory infections |
Primary outcome
genotyping of IL 17
Time frame: 3-6-2021 to 30-8-2021
real time pcr detection of different genotypes
genotyping of IL 23
Time frame: 3-6-2021 to 30-8-2021
real time pcr detection of different genotypes
estimation of serum level of IL 17
Time frame: 3-6-2021 to 30-8-2021
measuring serum level of IL 17 by ELISA
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 25 Oct 2022.
- Individual participant dataSharing planned: No. to protect the privacy of the patient
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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.
N S shafik, lecturer principal investigator
Sohag University
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 COVID-19 Respiratory Infection, run by Sohag 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 1 inclusion and 1 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 25 Oct 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?
genotyping of IL 17 (time frame: 3-6-2021 to 30-8-2021). The study lists 3 primary outcomes in all. 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 25 Oct 2022.