Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04746521
Status:
UNKNOWN
Last Update Posted:
2022-02-14
First Post:
2021-02-08
Brief Title:
Cellular-Mediated Immunity in COVID-19
Sponsor:
University of Campania Luigi Vanvitelli
Organization:
University of Campania Luigi Vanvitelli
Study Overview
Official Title:
DEtection of Cellular-MEdiated immuniTy in COVID-19 Patients and Subjects Who undeRgone vAccination Program
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEMETRA
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 AORN Ospedali dei Colli Cotugno Hospital Naples Italy of which N50 with thromboembolic complications PE and N50 without thromboembolic complications PE-
2 A total of N50 healthy subjects never diagnosed with Sars-Cov2 infection among the volunteer blood donors attending the UOC 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
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 AORN Ospedali dei Colli Cotugno Hospital Naples Italy of which N50 with thromboembolic complications PE and N50 without thromboembolic complications PE-
2 A total of N50 healthy subjects never diagnosed with Sars-Cov2 infection among the volunteer blood donors attending the UOC 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None