Covid19NCT04531319
Immune Cell Subgroups in Covid 19 Patients
An observational study of Covid19, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
COVID-19, spreading rapidly all over the world, causes serious morbidity and mortality. In severe COVID-19 infections, after pulmonary inflammation, cardiovascular organ failure, cytokine storm, hemophagocytosis, septic shock, develops due to uncontrolled hypoxia, and isolated organ failure turns into multi-organ… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Flow cytometric analysis
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2020to 1 Oct 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who admitted to the emergency department with the complaint of respiratory failure, lymphopenia in blood tests and Covid 19 (+) in the PCR tests are case group. Also healty volunteers who don't have complaint of respiratory failure, lymphopenia in blood tests and Covid 19 (-) in the PCR tests are control group.
Who may be able to join
- Patients with Covid 19 PCR (+) results
Who cannot join
- Cancer Patients
- Patients with known immunodeficiency
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Reseach Hospital
Istanbul, 34098
About this study
Official title: Evaluation of Immune Cell Subgroups in Covid 19 Patients
COVID-19, spreading rapidly all over the world, causes serious morbidity and mortality. In severe COVID-19 infections, after pulmonary inflammation, cardiovascular organ failure, cytokine storm, hemophagocytosis, septic shock, develops due to uncontrolled hypoxia, and isolated organ failure turns into multi-organ failure. It is noteworthy that it causes lymphopenia in patients. In studies conducted, the effects of Covid-19 on the immune system were evaluated with limited parameters. In addition, no study evaluating the effect of this disease on the immune system has been published in our country.
Read the detailed description
The causative agent of coronavirus 2019 (COVID-19) disease, which started in Wuhan province of China in December 2019, was severe acute respiratory failure syndrome coronavirus 2 (SARS-CoV-2), which quickly spread all over the world and caused a pandemic. COVID-19 can cause death with symptoms such as fever, cough, muscle pain, shortness of breath, and pneumonia (1). Pulmonary pathology of COVID-19 is diffuse alveolar damage, focal reactive hyperplasia of pneumocytes with patchy inflammatory cells, intravascular thrombosis, monocyte, macrophage and lymphocyte infiltration into pulmonary spaces. Severe infiltration of pulmonary tissue affects alveolar gas exchange. In addition, cardiovascular morbidity, tachyarrhythmia and thromboembolic events are observed in 1/5 of the hospitalized patients with troponin elevation, which is closely related to mortality. In severe COVID-19 infections, after pulmonary inflammation, cardiovascular organ failure, cytokine storm, hemophagocytosis, septic shock, develops due to uncontrolled hypoxia, and isolated organ failure turns into multi-organ failure.
It is noteworthy that it causes lymphopenia in patients. In the studies conducted, the effects of Covid-19 on the immune system and the determination of cell subgroups were performed with limited parameters. No studies have been conducted on PDL-1, one of the immune control points. In addition, no study evaluating the effect of this disease on the immune system with wide parameters has been published in our country.
We aimed to study CD3 (+) lymphocytes, CD4 (+) lymphocytes, CD 8 (+) lymphocytes, CD 3(-)/CD16 (+) NK cell ratio, CD14 (+) lymphocytes, and HLA-DR positivity on CD14 (+) cells at Covid-19 and healthy volunteers.
- Conditions
- Covid19
- Being tested
- Flow cytometric analysis
- Keywords
- T helper cell, T cytotoxic cell, Monocyte, NK cell
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow cytometric analysisDiagnostic test
Flow cytometric analysis of T helper, T cytotoxic cells, NK cells and monocytes
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Covid 19 (+) patients Receives: Diagnostic Test: Flow cytometric analysis | |
| Control Group | Healthy volunteers Receives: Diagnostic Test: Flow cytometric analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell subtype ratios
T helper, NK cell and T cytotoxic cell ratio
Measured: 1 month
Secondary outcomes (1)
Monocyte ratio
CD14 (+) monocyte and HLA-DR (+) cell ratio
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start15 Aug 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Oguz Idiz, Istanbul Training and Research Hospital
- Investigators
- Ufuk Oguz Idiz, Assoc. Prof, Principal investigator, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531319
- Sponsor's protocol ID
- Covid Cell
- Status last verified
- Jan 2021
- First submitted
- 27 Aug 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bi Q, Wu Y, Mei S, Ye C, Zou X, Zhang Z, Liu X, Wei L, Truelove SA, Zhang T, Gao W, Cheng C, Tang X, Wu X, Wu Y, Sun B, Huang S, Sun Y, Zhang J, Ma T, Lessler J, Feng T. Epidemiology and transmission of COVID-19 in 391 cases and 1286 of their close contacts in Shenzhen, China: a retrospective cohort study. Lancet Infect Dis. 2020 Aug;20(8):911-919. doi: 10.1016/S1473-3099(20)30287-5. Epub 2020 Apr 27.
PubMed 32353347Felsenstein S, Herbert JA, McNamara PS, Hedrich CM. COVID-19: Immunology and treatment options. Clin Immunol. 2020 Jun;215:108448. doi: 10.1016/j.clim.2020.108448. Epub 2020 Apr 27.
PubMed 32353634Ganji A, Farahani I, Khansarinejad B, Ghazavi A, Mosayebi G. Increased expression of CD8 marker on T-cells in COVID-19 patients. Blood Cells Mol Dis. 2020 Jul;83:102437. doi: 10.1016/j.bcmd.2020.102437. Epub 2020 Apr 13.
PubMed 32325421
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immune Cell Subgroups in Covid 19 Patients
- ClinicalTrials.gov ID
- NCT04531319
- Acronym / sponsor ID
- Covid Cell
- Conditions
- Covid19
- Keywords
- T helper cell, T cytotoxic cell, Monocyte, NK cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 28 Aug 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.
COVID-19, spreading rapidly all over the world, causes serious morbidity and mortality. In severe COVID-19 infections, after pulmonary inflammation, cardiovascular organ failure, cytokine storm, hemophagocytosis, septic shock, develops due to uncontrolled hypoxia, and isolated organ failure turns into multi-organ failure. It is noteworthy that it causes lymphopenia in patients. In studies conducted, the effects of Covid-19 on the immune system were evaluated with limited parameters. In addition, no study evaluating the effect of this disease on the immune system has been published in our country.
Detailed description
The causative agent of coronavirus 2019 (COVID-19) disease, which started in Wuhan province of China in December 2019, was severe acute respiratory failure syndrome coronavirus 2 (SARS-CoV-2), which quickly spread all over the world and caused a pandemic. COVID-19 can cause death with symptoms such as fever, cough, muscle pain, shortness of breath, and pneumonia (1). Pulmonary pathology of COVID-19 is diffuse alveolar damage, focal reactive hyperplasia of pneumocytes with patchy inflammatory cells, intravascular thrombosis, monocyte, macrophage and lymphocyte infiltration into pulmonary spaces. Severe infiltration of pulmonary tissue affects alveolar gas exchange. In addition, cardiovascular morbidity, tachyarrhythmia and thromboembolic events are observed in 1/5 of the hospitalized patients with troponin elevation, which is closely related to mortality. In severe COVID-19 infections, after pulmonary inflammation, cardiovascular organ failure, cytokine storm, hemophagocytosis, septic shock, develops due to uncontrolled hypoxia, and isolated organ failure turns into multi-organ failure.
It is noteworthy that it causes lymphopenia in patients. In the studies conducted, the effects of Covid-19 on the immune system and the determination of cell subgroups were performed with limited parameters. No studies have been conducted on PDL-1, one of the immune control points. In addition, no study evaluating the effect of this disease on the immune system with wide parameters has been published in our country.
We aimed to study CD3 (+) lymphocytes, CD4 (+) lymphocytes, CD 8 (+) lymphocytes, CD 3(-)/CD16 (+) NK cell ratio, CD14 (+) lymphocytes, and HLA-DR positivity on CD14 (+) cells at Covid-19 and healthy volunteers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Diagnostic Test: Flow cytometric analysisCovid 19 (+) patients |
| Control Group | – | Diagnostic Test: Flow cytometric analysisHealthy volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who admitted to the emergency department with the complaint of respiratory failure, lymphopenia in blood tests and Covid 19 (+) in the PCR tests are case group. Also healty volunteers who don't have complaint of respiratory failure, lymphopenia in blood tests and Covid 19 (-) in the PCR tests are control group.
Key inclusion criteria (1 listed)
- Patients with Covid 19 PCR (+) results
Key exclusion criteria (3 listed)
- Cancer Patients
- Patients with known immunodeficiency
- Pregnancy
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 |
|---|---|---|
| Flow cytometric analysisFlow cytometric analysis of T helper, T cytotoxic cells, NK cells and monocytes | Diagnostic test | Case Group, Control Group |
Primary outcome
T cell subtype ratios
Time frame: 1 month
T helper, NK cell and T cytotoxic cell ratio
1 secondary outcome
Monocyte ratio
Time frame: 1 month
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 12 Jan 2021.
- Background: PubMed 32353347Bi Q, Wu Y, Mei S, Ye C, Zou X, Zhang Z, Liu X, Wei L, Truelove SA, Zhang T, Gao W, Cheng C, Tang X, Wu X, Wu Y, Sun B, Huang S, Sun Y, Zhang J, Ma T, Lessler J, Feng T. Epidemiology and transmission of COVID-19 in 391 cases and 1286 of their close contacts in Shenzhen, China: a retrospective cohort study. Lancet Infect Dis. 2020 Aug;20(8):911-919. doi: 10.1016/S1473-3099(20)30287-5. Epub 2020 Apr 27.
- Background: PubMed 32353634Felsenstein S, Herbert JA, McNamara PS, Hedrich CM. COVID-19: Immunology and treatment options. Clin Immunol. 2020 Jun;215:108448. doi: 10.1016/j.clim.2020.108448. Epub 2020 Apr 27.
- Background: PubMed 32325421Ganji A, Farahani I, Khansarinejad B, Ghazavi A, Mosayebi G. Increased expression of CD8 marker on T-cells in COVID-19 patients. Blood Cells Mol Dis. 2020 Jul;83:102437. doi: 10.1016/j.bcmd.2020.102437. Epub 2020 Apr 13.
- Individual participant dataSharing planned: Undecided
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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.
Ufuk Oguz Idiz, Assoc. Prof principal investigator
Istanbul Training and Research Hospital
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 Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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 12 Jan 2021. 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 Turkey (Türkiye). 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?
T cell subtype ratios (time frame: 1 month). 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 NCT04531319, which also lists 3 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 12 Jan 2021.