Immune Cell Subgroups in Covid 19 Patients

NCT ID: NCT04531319

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-15
• Study Completion Date: 2020-10-01

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 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.

Conditions

Covid19

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case Group

Covid 19 (+) patients

Flow cytometric analysis

Intervention Type: DIAGNOSTIC_TEST

Flow cytometric analysis of T helper, T cytotoxic cells, NK cells and monocytes

Control Group

Healthy volunteers

Flow cytometric analysis

Intervention Type: DIAGNOSTIC_TEST

Flow cytometric analysis of T helper, T cytotoxic cells, NK cells and monocytes

Interventions

Flow cytometric analysis

Flow cytometric analysis of T helper, T cytotoxic cells, NK cells and monocytes

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients with Covid 19 PCR (+) results

Exclusion Criteria

• Cancer Patients
• Patients with known immunodeficiency
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ufuk Oguz Idiz

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ufuk Oguz Idiz, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Istanbul Training and Research Hospital

Locations

Istanbul Training and Reseach Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 32353347 (View on PubMed)

Felsenstein 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.

Reference Type: BACKGROUND

PMID: 32353634 (View on PubMed)

Ganji 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.

Reference Type: BACKGROUND

PMID: 32325421 (View on PubMed)

Other Identifiers

Covid Cell

Identifier Type: -

Identifier Source: org_study_id