Cellular-Mediated Immunity in COVID-19

• Conditions: Covid19; Thromboembolism
• Interventions: Biological: genomicDNA extraction; Diagnostic Test: Multitest 6 color TBNK and BD Lyotubes

• Registration Number: NCT04746521
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief 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.

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)

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-09
• Study Start: 2021-03-14
• Status Verified: 2022-01
• Primary Completion: 2022-01-14
• Last Update Submitted: 2022-01-30
• Last Update Posted: 2022-02-14
• Study Completion: 2022-12-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age > 18 years
• Previous diagnosis of COVID-19
• Absence of COVID-19 diagnosis

Exclusion Criteria

• Age <18 years
• Inflammatory diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe COVID-19 hospitalized patients	genomicDNA extraction	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) will be recruited, of which N=50 with thromboembolic complications (PE+) and N=50 without thromboembolic complications (PE-) balanced for age and sex of individuals.
Healthy controls (comparator group)	genomicDNA extraction	As control group (CTRL), we will recruit 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).
COVID-19 patients compared with vaccinated subjects	Multitest 6 color TBNK and BD Lyotubes	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

Primary Outcome Measures

Name	Time	Method
Detection of Cellular-Mediated Immune Response	3 Months	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

Secondary Outcome Measures

Name	Time	Method
Detection of T cell subpopulation maturation	5 months	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.

Trial Locations

Locations (1)

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