Immune Cell Subgroups in Covid 19 Patients

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: Flow cytometric analysis

• Registration Number: NCT04531319
• Lead Sponsor: 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 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.

Study Timeline

• Study Start: 2020-08-15
• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-08-28
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with Covid 19 PCR (+) results

Exclusion Criteria

• Cancer Patients
• Patients with known immunodeficiency
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case Group	Flow cytometric analysis	Covid 19 (+) patients
Control Group	Flow cytometric analysis	Healthy volunteers

Primary Outcome Measures

Name	Time	Method
T cell subtype ratios	1 month	T helper, NK cell and T cytotoxic cell ratio

Secondary Outcome Measures

Name	Time	Method
Monocyte ratio	1 month	CD14 (+) monocyte and HLA-DR (+) cell ratio

Trial Locations

Locations (1)

Istanbul Training and Reseach Hospital; 🇹🇷 Istanbul, Turkey