COVID-19, SARS CoV 2 Infection
Conditions
Brief summary
Infection by the recent Coronavirus (SARS-CoV-2) has generated at a pandemic level a new pathology, called COVID-19, characterized by flu-like symptoms up to severe acute respiratory failure. The pathogenesis of the disease involves both humoral and cellular immunological responses; cell-mediated immunity is the first and most effective immune response to viral infection. To date, despite the extensive scientific research aimed at curing COVID-19, there are few effective means to tackle SARS-CoV-2 infection and reduce its disease progression. Among these, a first complete anti-SARS-CoV-2 vaccination course has been shown to significantly reduce the development of the disease towards the more severe forms requiring hospital and intensive care. On the other hand, over time the antibody response induced by vaccines against SARS-CoV-2 decreases, so much so as to indicate the need for a third booster dose. This translates into the fact that some patients who have undergone a complete first vaccination course, with third dose booster indications, develop severe critical disease, with the need for hospitalization. On the other hand, other patients with the same vaccination status do not develop the disease, although they are also positive for SARS-CoV-2. The investigators therefore hypothesized that the humoral and cell-mediated response among groups of patients may be radically different. For these reasons, the investigators designed this observational pilot study in order to analyze humoral and cell-mediated responses in SARS-CoV-2 positive first complete vaccination patients.
Interventions
DIAGNOSTIC_TESTLIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)
Kit to test the concentration of Immunoglobulin G anti-SARS-CoV-2 in the plasma of included patients
DIAGNOSTIC_TESTLIAISON SARS-CoV2-IgM (DiaSorin)
Kit to test the concentration of Immunoglobulin M anti-SARS-CoV-2 in the plasma of included patients
DIAGNOSTIC_TESTHuman IFN-g ELISpot PLUS (ALP) (AUROGENE)
Kit to test the cellular immunity response by measuring the Interferon gamma released by mononuclear cells (PBMCs)
Sponsors
University Magna Graecia
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a complete first-cycle vaccination against SARS-CoV-2 performed 4 to 7 months before.
Exclusion criteria
* Presence of malignancy under chemotherapy * Patient with previous transplantation * Patient receiving immuno-modulatory or immunosuppressive drugs * Patient receiving corticosteroid therapy since more than 10 days * Pregnancy * Consent withdrawal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences between populations with respect to anti-SARS-CoV-2 immunoglobulins | At day 0 | After obtaining plasma of included patients, the plasma will be processed with a dedicated kit to measure the concentration of Immunoglobulin G and M. Differences between patients' cohorts will be assessed |
| Differences between populations with respect to cellular immunity | At day 0 | Mononuclear immunity cells will be analyzed with a dedicated ELISpot kit to assess their response to SARS-CoV-2 |
Countries
Italy
Outcome results
None listed