Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection

Study Overview
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Brief Summary
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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.

Official Title
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Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection

Conditions
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Corona Virus Infection

Intervention / Treatment
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* Diagnostic Test: ELISPOT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with an acute SARS-CoV-2 infection, confirmed by PCR or typical CT images, requiring hospitalization in a COVID unit at the Rouen University Hospital (pneumonic form requiring oxygen therapy < 4 L/min.) 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 Age ≥ 18 years old Adult patient who has read and understood the information letter and signed the consent form Affiliation to a social security scheme Exclusion Criteria: Patient with PCR-confirmed SARS-CoV-2 infection and hospitalized in intensive care units (acute respiratory distress and/or organ failure, whose pathogenesis may differ from the more frequently described forms with secondary aggravation (5)). Patient with PCR-confirmed but non-hospitalized SARS-CoV-2 infection (non-acute form, managed by confinement) A person participating in a therapeutic trial that may interfere with the procedures being investigated, including lymphocyte response prior to D+56±14 days. Known Pregnancy Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship Staff at the Rouen University Hospital with SARS-CoV-2 infection confirmed by PCR and/or typical scan images during the epidemic period. Hospital staff who were exposed to the virus (working in a Covid unit)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient group<br>- 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. | Diagnostic Test: ELISPOT<br>* 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.<br>|
| No Intervention: control group<br>- 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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |