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

In order to prevent reinfection, it is needed to detect the cellular-mediated immuneresponse to the Sars-CoV-2 infection. The first goal of this study will be to detect thecellular-mediated immune response in patients affected by COVID-19 (with or withoutvaccination) and healthy subjects who undergone vaccination program. The second goal ofthis study will be to identify the genetic and epigenetic biomarkers that influenceindividual immunological response and clinical evolution to the severe manifestations ofthe COVID-19.

Detailed 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)

Unknown status
COVID19
Thromboembolism

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

Eligibility Criteria

Inclusion Criteria:

- Age > 18 years

- Previous diagnosis of COVID-19

- Absence of COVID-19 diagnosis

Exclusion Criteria:

- Age <18 years

- Inflammatory diseases

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

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, Italy

Investigator: Giuditta Benincasa, BiolD, MSc
giuditta.benincasa@unicampania.it

Contacts

Giuditta Benincasa, BiolD. MSc
+39 0815667916
giuditta.benincasa@unicampania.it

University of Campania Luigi Vanvitelli
NCT Number
MeSH Terms
COVID-19
Thromboembolism