Cellular-Mediated Immunity in COVID-19

Covid19 Clinical Trial

— DEMETRA  

Official title:

DEtection of Cellular-MEdiated immuniTy in COVID-19 Patients and Subjects Who undeRgone vAccination Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04746521
• Other study ID #: L. Vanvitelli
• Status: Recruiting
• Start date: March 14, 2021
• Est. completion date: December 14, 2022

Study information

• Verified date: January 2022
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Giuditta Benincasa, BiolD. MSc
• Phone: +39 0815667916
• Email: giuditta.benincasa[@]unicampania.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In order to prevent reinfection, it is needed to detect the cellular-mediated immune response to the Sars-CoV-2 infection. The first goal of this study will be to detect the cellular-mediated immune response in patients affected by COVID-19 (with or without vaccination) and healthy subjects who undergone vaccination program. The second goal of this study will be to identify the genetic and epigenetic biomarkers that influence individual immunological response and clinical evolution to the severe manifestations of the COVID-19.

Description:

First goal: Characterization of the immune response using detailed phenotypic evaluation of the adaptive compartment comprising B, T, and NK cells. The Investigators aim is to detect the cellular-mediated immune response in patients affected by COVID-19 and subjects who undergone vaccination program.

The Investigators will recruit three classes of subjects:

1. Patients with previous Sars-CoV-2 infection who did not undergo vaccination;

2. Patients with previous Sars-CoV-2 infection who undergone vaccination;

3. Subjects without previous Sars-CoV-2 infection who undergone vaccination.

Second goal: Evaluation of genetic and epigenetic biomarkers that influence individual immunological response and susceptibility to thromboembolic manifestations in severe COVID-19 hospitalized patients.

The Investigators will recruit:

1. A total of 50 severe COVID-19 patients admitted to the Sub-Intensive Care Unit of A.O.R.N. Ospedali dei Colli, Cotugno Hospital, Naples (Italy) of which N=50 with thromboembolic complications (PE+) and N=50 without thromboembolic complications (PE-);

2. A total of N=50 healthy subjects (never diagnosed with Sars-Cov2 infection) among the volunteer blood donors attending the U.O.C. Divisione di Immunologia Clinica, Immunoematologia, Medicina Trasfusionale e Immunologia dei Trapianti, Dipartimento di Medicina Interna e Specialistica, AOU, "L. Vanvitelli" University of Campania (Naples, Italy)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Previous diagnosis of COVID-19

• Absence of COVID-19 diagnosis

Exclusion Criteria:

• Age <18 years

• Inflammatory diseases

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Thromboembolism

Intervention

Diagnostic Test:
• Multitest 6 color TBNK and BD Lyotubes
The Multitest 6 color TBNK allows us to count the population-specific B, T, NK cells

Biological:
• genomicDNA extraction
Peripheral blood biospecimens (about 10-15 mL) will be collected through venipuncture in EDTA tubes. Peripheral blood mononuclear cells (PBMCs) will be isolated using Ficoll® Paque Plus (Sigma-Aldrich) centrifugation gradient and genomic DNA will be extracted from fresh PBMCs using DNeasy Blood & Tissue kit (QIAGEN), according to manufacturer protocols

Locations

Country	Name	City	State
Italy	U.O.C. Division of Clinical Immunology, Immunohematology, Transfusion Medicine and Transplant Immunology, Regional Reference Laboratory of Transplant Immunology, Department of Internal and Specialty Medicine, A.O.U., UniversityofCampania "Luigi Vanvitelli	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Cellular-Mediated Immune Response	The Investigators will perform the BD Multitest 6-color TBNK by using 50 uL of peripheral blood to detect the absolute number (N) of CD3+, CD19+, CD16+, CD46+, CD4+ and CD8+ cells.	3 Months
Primary	Detection of Cellular-Mediated Immune Response	The Investigators will perform the BD™ Lyotubes kit by using 150 uL of peripheral blood to detect the absolute number (N) of CD4+ and CD8+ cells undergoing to differentiation from naive T cells to central memory, effector memory, and terminal memory	3 Months
Secondary	Detection of T cell subpopulation maturation	The Investigators will perform the BD™ Lyotubes kit by using 150 uL of peripheral blood to detect the absolute number (N) of CD4+ and CD8+ cells undergoing to differentiation from naive T cells to central memory, effector memory, and terminal memory.	5 months
Secondary	Detection of T cell subpopulation maturation	The Investigators will perform the BD™ Lyotubes kit by using 150 uL of peripheral blood to detect the % of CD4+ and CD8+ cells undergoing to differentiation from naive T cells to central memory, effector memory, and terminal memory.	5 months