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Functional Exhaustion of T Cells in COVID19 Patients

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ClinicalTrials.gov Identifier: NCT04470323
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Hebatallah Hassan, 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.

Condition or disease Intervention/treatment
T Cell Deficiency Diagnostic Test: Flow cytometry

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Functional Exhaustion of T Cells in COVID19 Patients
Actual Study Start Date : July 22, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Group/Cohort Intervention/treatment
COVID19 patients
Patients admitted to Assiut university Hospitals diagnosed as COVID19 positive patients by PCR.
Diagnostic Test: Flow cytometry
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.

healthy volunteer
as negative control for each sample
Diagnostic Test: Flow cytometry
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.




Primary Outcome Measures :
  1. CD4+ (T-helper cells) in COVID 19 patients and healthy volunteers. [ Time Frame: Baseline ]
    Detection of the percentage of CD4+ (T-helper cells) in COVID 19 patients and healthy volunteers.

  2. CD8+ (T-cytotoxic cells) in COVID 19 patients and healthy volunteers. [ Time Frame: Baseline ]
    Detection of the percentage of CD8+ (T-cytotoxic cells) in COVID 19 patients and healthy volunteers .

  3. Detect PD-1 on CD8+ and CD4+ cells in COVID 19 patients and healthy volunteers . [ Time Frame: Baseline ]
    Detection of the percentage of expression of PD-1 on CD8+ and CD4+ cells in COVID 19 patient and healthy volunteers.

  4. Detect CD28+ and CD3+ cells in COVID 19 patients and healthy volunteers. [ Time Frame: Baseline ]
    Detection of the frequency of CD28+ and CD3+ cells in COVID 19 patients and healthy volunteers .


Biospecimen Retention:   Samples With DNA
Peripheral blood samples from patients and healthy volunteers were supplemented with anticoagulants (EDTA-K2).


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to Assiut university Hospitals diagnosed as COVID-19 positive patients by PCR.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no exclusion criteriae

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470323


Contacts
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Contact: Hebatallah Hassan, Lecturer 01022182086 heba.ismailhassan@gmail.com

Locations
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Egypt
Faculty of Medicine Recruiting
Assiut, Egypt, 71515
Sponsors and Collaborators
Assiut University
Publications:

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Responsible Party: Hebatallah Hassan, dr, Assiut University
ClinicalTrials.gov Identifier: NCT04470323    
Other Study ID Numbers: T cells
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No