Cellular-Mediated Immunity in COVID-19

NCT04746521 | Unknown

• 1 other identifier: L. Vanvitelli
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Thromboembolism

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Detection of T cell subpopulation maturation

  5 months

• Detection of T cell subpopulation maturation

  5 months

Study Arms (3)

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.

Biological: genomicDNA extraction

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).

Biological: genomicDNA extraction

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

Diagnostic Test: Multitest 6 color TBNK and BD Lyotubes

Interventions

Multitest 6 color TBNK and BD Lyotubes DIAGNOSTIC_TEST

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

COVID-19 patients compared with vaccinated subjects

genomicDNA extraction 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); Severe COVID-19 hospitalized patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases: Patients with previous diagnosed Sars-CoV-2 infection who did undergo vaccination. Patients with previous diagnosed Sars-CoV-2 infection who did not undergo vaccination. Subjects without diagnosed Sars-CoV-2 infection who adhered to vaccination program. \-

You may qualify if:

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

You may not qualify if:

• Age \<18 years
• Inflammatory diseases

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (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, 80138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood, genomic DNA, RNA, and proteins.

MeSH Terms

Conditions

COVID-19; Thromboembolism

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Giuditta Benincasa, BiolD. MSc

CONTACT

+39 0815667916; giuditta.benincasa@unicampania.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 9, 2021
• Study Start: March 14, 2021
• Primary Completion: January 14, 2022
• Study Completion: December 14, 2022
• Last Updated: February 14, 2022

Record last verified: 2022-01

Locations

IT (1)