Cytokine Status of Covid-19 Patients
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ClinicalTrials.gov Identifier: NCT04531345 |
Recruitment Status :
Completed
First Posted : August 28, 2020
Last Update Posted : January 12, 2021
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Condition or disease | Intervention/treatment |
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Covid19 | Diagnostic Test: Flow cytometric analysis |
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 , the blood levels of certain inflammatory cytokines, interleukin-1β,interleukin-6 and TNF-α, were evaluated. In addition, blood values of a limited number of cytokines were investigated in a similar way in a limited number of studies published in our country.
We aimed to study IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 at Covid 19 and healthy volunteers.
Study Type : | Observational |
Actual Enrollment : | 60 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | The Cytokine Status of Covid-19 Patients |
Actual Study Start Date : | October 1, 2020 |
Actual Primary Completion Date : | November 1, 2020 |
Actual Study Completion Date : | November 15, 2020 |

Group/Cohort | Intervention/treatment |
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Case Group
Patients with Covid 19 PCR (+) results
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Diagnostic Test: Flow cytometric analysis
IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 cytokine analysis of COvid-19 patients and healthy volunteers |
Control Group
Healthy volunteers
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Diagnostic Test: Flow cytometric analysis
IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 cytokine analysis of COvid-19 patients and healthy volunteers |
- Cytokine levels of patients [ Time Frame: 1 month ]IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 levels

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- Patients with Covid 19 PCR (+) results
Exclusion Criteria:
- Cancer Patients
- Patients with known immunodeficiency
- Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531345
Turkey | |
Istanbul Training and Reseach Hospital | |
Istanbul, Turkey, 34098 |
Principal Investigator: | Ufuk Oguz Idiz, Assoc. Prof | Istanbul Training and Research Hospital |
Responsible Party: | Ufuk Oguz Idiz, Assoc. Prof., Istanbul Training and Research Hospital |
ClinicalTrials.gov Identifier: | NCT04531345 |
Other Study ID Numbers: |
Covid Cytokine |
First Posted: | August 28, 2020 Key Record Dates |
Last Update Posted: | January 12, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
interleukin cytokine |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |