Cellular-Mediated Immunity in COVID-19

NCT ID: NCT04746521

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-14
• Study Completion Date: 2022-12-14

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)

Conditions

Covid19; Thromboembolism

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Severe COVID-19 hospitalized patients

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.

genomicDNA extraction

Intervention Type: BIOLOGICAL

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

Healthy controls (comparator group)

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).

genomicDNA extraction

Intervention Type: BIOLOGICAL

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

COVID-19 patients compared with vaccinated 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

Multitest 6 color TBNK and BD Lyotubes

Intervention Type: DIAGNOSTIC_TEST

The Multitest 6 color TBNK allows us to count the population-specific B, T, NK cells

Interventions

Multitest 6 color TBNK and BD Lyotubes

The Multitest 6 color TBNK allows us to count the population-specific B, T, NK cells

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Age <18 years
• Inflammatory diseases

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Giuditta Benincasa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

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

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giuditta Benincasa, BiolD. MSc

Role: CONTACT

giuditta.benincasa@unicampania.it

+39 0815667916

Facility Contacts

Giuditta Benincasa, BiolD, MSc

Role: primary

giuditta.benincasa@unicampania.it

Other Identifiers

L. Vanvitelli

Identifier Type: -

Identifier Source: org_study_id