NCT04746521

Cellular-Mediated Immunity in COVID-19

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-03-14
• Primary completion: 2022-01-14
• Completion: 2022-12-14
• First posted: 2021-02-09
• Last updated: 2022-02-14

Locations

1 site across 1 country: Italy