Functional Exhaustion of T Cells in COVID19 Patients

Study Overview
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Brief Summary
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The primary end-point of our prospective, observational study is to count T cells in patients with laboratory-confirmed COVID-19 and healthy controls. In addition, the expression of T cell exhaustion marker was measured in COVID-19 cases.

Detailed Description
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COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has posed great threat to human health. T cells play a critical role in antiviral immunity but their numbers and functional state in COVID-19 patients remain largely unclear. The immune response against viral infections depends on the activation of cytotoxic T cells that can clear infection by killing virus-infected cells, so boosting the numbers and function of T cells in COVID-19 patients is critical for successful recovery. However, the factors which might cause the reduction in count, and the activation status of T cells in COVID-19 patients, remain uninvestigated. Thus demonstration of T cell exhaustion during COVID-19 infection suggest that more urgent, early intervention may be required in patients with low T lymphocyte counts.

Official Title
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Functional Exhaustion of T Cells in COVID19 Patients

Conditions
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T Cell Deficiency

Intervention / Treatment
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* Diagnostic Test: Flow cytometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Covid-19 test positive; hospitalized subjects; both sexes; given informed consent. Exclusion Criteria: no exclusion criteriae
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID19 patients<br>Patients admitted to Assiut university Hospitals diagnosed as COVID19 positive patients by PCR. | Diagnostic Test: Flow cytometry<br>* Lymphocyte subsets in peripheral blood were assessed by staining 50 µl of blood sample with 5 µl of Fluoroisothiocyanate (FITC)-conjugated- PD-1, phycoerythrin (PE)-conjugated-CD8, peridinium-chlorophyll-protein (Per-CP)-conjugated-CD4, Peridinium-chlorophyll-protein (Per-CP)-conjugated anti-CD3 and allophycocyanin (APC) conjugated anti-CD28.<br>|
| healthy volunteer<br>as negative control for each sample | Diagnostic Test: Flow cytometry<br>* Lymphocyte subsets in peripheral blood were assessed by staining 50 µl of blood sample with 5 µl of Fluoroisothiocyanate (FITC)-conjugated- PD-1, phycoerythrin (PE)-conjugated-CD8, peridinium-chlorophyll-protein (Per-CP)-conjugated-CD4, Peridinium-chlorophyll-protein (Per-CP)-conjugated anti-CD3 and allophycocyanin (APC) conjugated anti-CD28.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4+ (T-helper cells) in COVID 19 patients and healthy volunteers. | Detection of the percentage of CD4+ (T-helper cells) in COVID 19 patients and healthy volunteers. | Baseline | 
| CD8+ (T-cytotoxic cells) in COVID 19 patients and healthy volunteers. | Detection of the percentage of CD8+ (T-cytotoxic cells) in COVID 19 patients and healthy volunteers . | Baseline | 
| Detect PD-1 on CD8+ and CD4+ cells in COVID 19 patients and healthy volunteers . | Detection of the percentage of expression of PD-1 on CD8+ and CD4+ cells in COVID 19 patient and healthy volunteers. | Baseline | 
| Detect CD28+ and CD3+ cells in COVID 19 patients and healthy volunteers. | Detection of the frequency of CD28+ and CD3+ cells in COVID 19 patients and healthy volunteers . | Baseline |