Cytokine Status of Covid-19 Patients

Covid19 Clinical Trial

Official title:

The Cytokine Status of Covid-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531345
• Other study ID #: Covid Cytokine
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: November 15, 2020

Study information

• Verified date: January 2021
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 15, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with Covid 19 PCR (+) results

Exclusion Criteria:

• Cancer Patients

• Patients with known immunodeficiency

• Pregnancy

Related Conditions & MeSH terms

• Covid19

Intervention

Diagnostic Test:
• Flow cytometric analysis
IL-1ß, IFN-a2, IFN-?, TNF-a, 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

Locations

Country	Name	City	State
Turkey	Istanbul Training and Reseach Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2. Review. — View Citation

Hu B, Huang S, Yin L. The cytokine storm and COVID-19. J Med Virol. 2020 Jun 27. doi: 10.1002/jmv.26232. [Epub ahead of print] Review. — View Citation

Soy M, Keser G, Atagündüz P, Tabak F, Atagündüz I, Kayhan S. Cytokine storm in COVID-19: pathogenesis and overview of anti-inflammatory agents used in treatment. Clin Rheumatol. 2020 Jul;39(7):2085-2094. doi: 10.1007/s10067-020-05190-5. Epub 2020 May 30. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine levels of patients	IL-1ß, IFN-a2, IFN-?, TNF-a, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 levels	1 month