COVID-19 Respiratory InfectionNCT05089110
Expression of Toll-like Receptors 3 , 7 and 9 in Peripheral Blood Mononuclear Cells of COVID-19 Patients
An observational study of COVID-19 Respiratory Infection, run by Assiut University.
Trial summary
The aim of the study is to assess the expression of TLR 3, 7, and 9 in the population of peripheral blood mononuclear cells (PBMC) and in B lymphocytes (CD19+), T lymphocytes (CD4+ and CD8+) using flow cytometry in relation to the clinical parameters and outcome of COVID 19 patients . Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Nov 2024
- 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 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients diagnosed as confirmed COVID-19 when they have a positive result of RT-PCR for SARS-CoV-2 RNA or confirmed diagnosis by typical clinical picture and radiological methods , according to the WHO and Egyptian Ministry of Health and Population (MOH) definitions, at Assiut University Hospital
Who may be able to join
- Patients ≥18 years old of both genders.
- Patients diagnosed as confirmed COVID-19 when they have a positive result of RT-PCR for SARS-CoV-2 RNA or confirmed diagnosis by typical clinical picture and radiological methods , according to the WHO and Egyptian Ministry of Health and Population (MOH) definitions, at Assiut University Hospital.
Who cannot join
- Children less than 18 years.
- Patients refusal to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the study is to assess the expression of TLR 3, 7, and 9 in the population of peripheral blood mononuclear cells (PBMC) and in B lymphocytes (CD19+), T lymphocytes (CD4+ and CD8+) using flow cytometry in relation to the clinical parameters and outcome of COVID 19 patients .
Read the detailed description
Abnormal stimulation of innate immunity may have a great influence on the immunopathogenesis of COVID 19 disease .The involvement of innate immunity receptors-toll-like receptors (TLR)-in the pathogenesis of COVID 19 is not adequately studied. The activation of these receptors by specific ligands is thought to initiate autoimmune processes[1]. TLR stimulation leads to increased expression of proinflammatory cytokines (IL-6, IFN
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleProcedure or surgery
5 cm blood sample from COVID-19 patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokines storm occurrence in COVID-19 patients
To assess whether the expression of toll-like receptors 3,7 and 9 in peripheral blood mononuclear cells related to the clinical status of COVID-19 patients and probability of cytokines storm occurrence
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fady Khalifa Musa Markos, Assiut University
- Investigators
- Gamal Agamy, professor, Study chair, Assiut UniversityMohammad Adam, professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089110
- Sponsor's protocol ID
- Immunity cells in COVID-19
- Status last verified
- Oct 2021
- First submitted
- 21 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, Herridge M, Randolph AG, Calfee CS. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019 Mar 14;5(1):18. doi: 10.1038/s41572-019-0069-0.
PubMed 30872586Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
PubMed 32192578
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Toll-like Receptors 3 , 7 and 9 in Peripheral Blood Mononuclear Cells of COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05089110
- Acronym / sponsor ID
- Immunity cells in COVID-19
- Conditions
- COVID-19 Respiratory Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 22 Oct 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.
The aim of the study is to assess the expression of TLR 3, 7, and 9 in the population of peripheral blood mononuclear cells (PBMC) and in B lymphocytes (CD19+), T lymphocytes (CD4+ and CD8+) using flow cytometry in relation to the clinical parameters and outcome of COVID 19 patients .
Detailed description
Abnormal stimulation of innate immunity may have a great influence on the immunopathogenesis of COVID 19 disease .The involvement of innate immunity receptors-toll-like receptors (TLR)-in the pathogenesis of COVID 19 is not adequately studied. The activation of these receptors by specific ligands is thought to initiate autoimmune processes[1]. TLR stimulation leads to increased expression of proinflammatory cytokines (IL-6, IFN
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as confirmed COVID-19 when they have a positive result of RT-PCR for SARS-CoV-2 RNA or confirmed diagnosis by typical clinical picture and radiological methods , according to the WHO and Egyptian Ministry of Health and Population (MOH) definitions, at Assiut University Hospital
Key inclusion criteria (2 listed)
- Patients ≥18 years old of both genders.
- Patients diagnosed as confirmed COVID-19 when they have a positive result of RT-PCR for SARS-CoV-2 RNA or confirmed diagnosis by typical clinical picture and radiological methods , according to the WHO and Egyptian Ministry of Health and Population (MOH) definitions, at Assiut University Hospital.
Key exclusion criteria (2 listed)
- Children less than 18 years.
- Patients refusal to participate in the study
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 |
|---|---|---|
| blood sample5 cm blood sample from COVID-19 patients | Procedure or surgery | – |
Primary outcome
Cytokines storm occurrence in COVID-19 patients
Time frame: Baseline
To assess whether the expression of toll-like receptors 3,7 and 9 in peripheral blood mononuclear cells related to the clinical status of COVID-19 patients and probability of cytokines storm occurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Background: PubMed 30872586Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, Herridge M, Randolph AG, Calfee CS. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019 Mar 14;5(1):18. doi: 10.1038/s41572-019-0069-0.
- Background: PubMed 32192578Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
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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.
Gamal Agamy, professor study chair
Assiut University
Mohammad Adam, professor study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Respiratory Infection, run by Assiut University.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fady Markos, resident doctor (01203456886, fadyfedo3296@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokines storm occurrence in COVID-19 patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05089110, which also lists 2 linked publications.
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 26 Oct 2021.