Functional Exhaustion of T Cells in COVID19 Patients

• Conditions: T Cell Deficiency

• 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

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