Functional Exhaustion of T Cells in COVID19 Patients

• Conditions: T Cell Deficiency
• Interventions: Diagnostic Test: Flow cytometry

• Registration Number: NCT04470323
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-07-12
• Study First Submitted QC: 2020-07-12
• Study First Posted: 2020-07-14
• Study Start: 2020-07-22
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-06
• Primary Completion: 2020-10
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of Covid-19 test positive; hospitalized subjects; both sexes; given informed consent.

Exclusion Criteria

• no exclusion criteriae

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy volunteer	Flow cytometry	as negative control for each sample
COVID19 patients	Flow cytometry	Patients admitted to Assiut university Hospitals diagnosed as COVID19 positive patients by PCR.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt