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The SARS-CoV-2 (COVID-19) infection is causing a global pandemic and a major health crisis in France.
Immunity is the body's ability to defend itself against infectious agents such as viruses. The progressive acquisition by a large part of the population of immunity to defend itself against the COVID-19 virus is one of the main mechanisms by which a resolution of this pandemic is hoped for. Recovery from infection and protection from the virus is likely to depend on the development of antibodies (proteins produced by the body to neutralize infectious agents) and T-cells (a type of white blood cell in the immune system) that can stop the virus from multiplying and killing it.
To date, the way and speed at which the T-lymphocytes active against the virus appear are not known. The development of biological tests to detect T-cells active against the virus in the blood of infected patients is therefore necessary.
In this context, we propose you to participate in a study that will study the immune system's response against the sars-CoV-2 virus during and after COVID-19 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient group | Experimental | - Patient with an acute SARS-CoV-2 infection, confirmed by PCR or typical CT images, requiring hospitalization in a COVID unit at Rouen University Hospital. |
|
| control group | No Intervention | - Rouen University Hospital staff free of any symptomatology compatible with an SARS-CoV-2 infection (fever, cough, fatigue, loss of taste, loss of smell) since February 1, 2020 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELISPOT | Diagnostic Test | The evolution of the number of gamma interferon (IFN) producing T lymphocytes in response to Spike glycoprotein (Spike glycoprotein) will be assessed by enumeration in ELISPOT method at 4 measurement times: D0 (confirmation of infection by PCR), D+7, D+14 or at hospital departure (D+Departure) and D+56±14 days. The ELISPOT method consists in stimulating peripheral blood mononuclear cells (isolated by density gradient and containing a known CD3+ T lymphocyte count) over a short period of time (16 to 20 hours) with a pool of 15 amino acid peptides (overlapping on 11 amino acids) representative of the S protein. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the number of gamma interferon (IFN) producing T lymphocytes in response to the S protein | The evolution of the number of interferon-gamma producing T lymphocytes (IFN) in response to protein S (Spike glycoprotein) will be assessed by enumeration in ELISPOT method | for 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of T lymphocytes producing IFN in response to other CoV-2-SARS viral | Numbers of T lymphocytes producing IFN in response to other CoV-2-SARS viral proteins (nucleoprotein, membrane proteins E (FEV1) and M (FEV1), proteins 3a, 9b, ORF10, non-structural proteins 6, 7a, 7b, 8, protein14) measured by ELISPOT | for 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rouen University Hospital | Rouen | France |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D058501 | Enzyme-Linked Immunospot Assay |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Anti-SARS-CoV-2 IgG and IgM levels |
Anti-SARS-CoV-2 IgG and IgM levels |
| for 56 days |
| SARS-CoV-2 viral load in nasopharyngeal swab | SARS-CoV-2 viral load in nasopharyngeal swab | for 56 days |
| D007239 |
| Infections |
| D008919 | Investigative Techniques |
| D004797 | Enzyme-Linked Immunosorbent Assay |
| D007124 | Immunoenzyme Techniques |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D007163 | Immunosorbent Techniques |
| D007150 | Immunohistochemistry |
| D015336 | Molecular Probe Techniques |