DEMETRA: Cellular-Mediated Immunity in COVID-19
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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Patients with previous Sars-CoV-2 infection who did not undergo vaccination;
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Patients with previous Sars-CoV-2 infection who undergone vaccination;
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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:
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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-);
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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
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| 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
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
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| COVID-19 patients compared with vaccinated subjects Patients with previous Sars-CoV-2 infection who did not undergo vaccination; Patients with previous Sars-CoV-2 infection who undergone vaccination Subjects without previous Sars-CoV-2 infection who undergone vaccination |
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
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Outcome Measures
Primary Outcome Measures
- Detection of Cellular-Mediated Immune Response [3 Months]
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.
- Detection of Cellular-Mediated Immune Response [3 Months]
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
Secondary Outcome Measures
- Detection of T cell subpopulation maturation [5 months]
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.
- Detection of T cell subpopulation maturation [5 months]
The Investigators will perform the BD™ Lyotubes kit by using 150 uL of peripheral blood to detect the % of CD4+ and CD8+ cells undergoing to differentiation from naive T cells to central memory, effector memory, and terminal memory.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 years
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Previous diagnosis of COVID-19
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Absence of COVID-19 diagnosis
Exclusion Criteria:
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Age <18 years
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Inflammatory diseases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 | Italy | 80138 |
Sponsors and Collaborators
- University of Campania "Luigi Vanvitelli"
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- L. Vanvitelli