Other Clinical Trial - Cellular-Mediated Immunity in COVID-19

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04746521
Study type	Observational
Source	University of Campania "Luigi Vanvitelli"
Contact	Giuditta Benincasa, BiolD. MSc
Phone	+39 0815667916
Email	giuditta.benincasa@unicampania.it
Status	Recruiting
Phase
Start date	March 14, 2021
Completion date	December 14, 2022

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cellular-Mediated Immunity in COVID-19 — DEMETRA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms