Clinical trial NCT04470323: Functional Exhaustion of T Cells in COVID19 Patients
Official title: Functional Exhaustion of T Cells in COVID19 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: T Cell Deficiency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Assiut university Hospitals diagnosed as COVID-19 positive patients by PCR.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* no exclusion criteriae

Primary outcomes:
measure: CD4+ (T-helper cells) in COVID 19 patients and healthy volunteers.
timeFrame: Baseline
measure: CD8+ (T-cytotoxic cells) in COVID 19 patients and healthy volunteers.
timeFrame: Baseline
measure: Detect PD-1 on CD8+ and CD4+ cells in COVID 19 patients and healthy volunteers .
timeFrame: Baseline
measure: Detect CD28+ and CD3+ cells in COVID 19 patients and healthy volunteers.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
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citation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.