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Cytokine Status of Covid-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04531345
Recruitment Status : Completed
First Posted : August 28, 2020
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Ufuk Oguz Idiz, Istanbul Training and Research Hospital

Brief 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 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 similarly in a limited number of studies published in our country.

Condition or disease Intervention/treatment
Covid19 Diagnostic Test: Flow cytometric analysis

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 , 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.

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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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Case Group
Patients with Covid 19 PCR (+) results
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
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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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
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.

Criteria

Inclusion Criteria:

  • Patients with Covid 19 PCR (+) results

Exclusion Criteria:

  • Cancer Patients
  • Patients with known immunodeficiency
  • Pregnancy

Information from the National Library of Medicine

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


Locations
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Turkey
Istanbul Training and Reseach Hospital
Istanbul, Turkey, 34098
Sponsors and Collaborators
Istanbul Training and Research Hospital
Investigators
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Principal Investigator: Ufuk Oguz Idiz, Assoc. Prof Istanbul Training and Research Hospital
Publications:
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ufuk Oguz Idiz, Istanbul Training and Research Hospital:
interleukin
cytokine
Additional relevant MeSH terms:
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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