Functional Exhaustion of T Cells in COVID19 Patients

NCT04470323 | Unknown

• 1 other identifier: T cells
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

T Cell Deficiency

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

COVID19 patients

Patients admitted to Assiut university Hospitals diagnosed as COVID19 positive patients by PCR.

Diagnostic Test: Flow cytometry

healthy volunteer

as negative control for each sample

Diagnostic Test: Flow cytometry

Interventions

Flow cytometry DIAGNOSTIC_TEST

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.

COVID19 patients; healthy volunteer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Assiut university Hospitals diagnosed as COVID-19 positive patients by PCR.

You may qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, 71515, Egypt

RECRUITING

Related Publications (5)

• Diao B, Wang C, Tan Y, Chen X, Liu Y, Ning L, Chen L, Li M, Liu Y, Wang G, Yuan Z, Feng Z, Zhang Y, Wu Y, Chen Y. Reduction and Functional Exhaustion of T Cells in Patients With Coronavirus Disease 2019 (COVID-19). Front Immunol. 2020 May 1;11:827. doi: 10.3389/fimmu.2020.00827. eCollection 2020.

  PMID: 32425950 BACKGROUND

• Li CK, Wu H, Yan H, Ma S, Wang L, Zhang M, Tang X, Temperton NJ, Weiss RA, Brenchley JM, Douek DC, Mongkolsapaya J, Tran BH, Lin CL, Screaton GR, Hou JL, McMichael AJ, Xu XN. T cell responses to whole SARS coronavirus in humans. J Immunol. 2008 Oct 15;181(8):5490-500. doi: 10.4049/jimmunol.181.8.5490.

  PMID: 18832706 BACKGROUND

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 BACKGROUND

• Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

  PMID: 32007143 BACKGROUND

• 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.

  PMID: 32031570 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples from patients and healthy volunteers were supplemented with anticoagulants (EDTA-K2).

MeSH Terms

Conditions

Thymic aplasia

Interventions

Flow Cytometry

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Hebatallah Hassan, Lecturer

CONTACT

01022182086; heba.ismailhassan@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 14, 2020
• Study Start: July 22, 2020
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)