Cytokine Status of Covid-19 Patients

Sponsor
Istanbul Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04531345
Collaborator
(none)
60
1
1.5
40.6

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Oct 1, 2020
Actual Primary Completion Date :
Nov 1, 2020
Actual Study Completion Date :
Nov 15, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Cytokine levels of patients [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients with Covid 19 PCR (+) results
Exclusion Criteria:
  • Cancer Patients

  • Patients with known immunodeficiency

  • Pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Training and Reseach Hospital Istanbul Turkey 34098

Sponsors and Collaborators

  • Istanbul Training and Research Hospital

Investigators

  • Principal Investigator: Ufuk Oguz Idiz, Assoc. Prof, Istanbul Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ufuk Oguz Idiz, Assoc. Prof., Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04531345
Other Study ID Numbers:
  • Covid Cytokine
First Posted:
Aug 28, 2020
Last Update Posted:
Jan 12, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ufuk Oguz Idiz, Assoc. Prof., Istanbul Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2021