COVID-19: SARS-CoV-2 Specific Memory B and T-CD4+ Cells

Study Overview
=================
Brief Summary
-----------------
The current pandemic caused by the newly identified coronavirus responsible for COVID-19 is a major threat to our populations and societies. Hypothesis/Objective The acquisition of protective immunity at the level of the individual, either through vaccination or natural resolution of the infection, progressively leads at the level of the population to the reduction of the fraction of the population that can be productively infected and transmit the virus, hence, leading to the diminution of the rate of transmission, a phenomenon called herd immunity. Herd immunity was proposed as a strategy to control the infection. However, it remains difficult to model group immunity given the limited knowledge of the interaction between the host immune system with the virus, whose capacity to evolve in face of a neutralizing response is also not known. It is therefore important to acquire a better knowledge of the immunological memory that ensures the resolution of COVID-19 after SARS-CoV2 infection. Method To study single-cell B and T memory cells specific for the anti-SARS-CoV-2 response and characterize somatic mutations of immunoglobulin genes and TCR, in hospitalized and symptomatic patients and in patients cured of SARS-CoV-2.

Official Title
-----------------
SARS-CoV-2 Specific Memory B and T- CD4+ Cells

Conditions
-----------------
COVID-19, SARS-CoV-2 Infection

Intervention / Treatment
-----------------
* Other: 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )
* Other: 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have recovered from CoV-2-SARS Adult patient (≥ 18 years old) with a positive SARS-CoV-2 PCR. Adult patient (≥ 18 years old) who has recovered from SARS-CoV-2 i.e. has been free of clinical symptoms for more than 15 days and has not been hospitalized and for less than 6 weeks. Patient affiliated to a social security scheme. Patients hospitalized for SARS-CoV-2 Adult patient (≥ 18 years old) with a positive SARS-CoV-2 PCR. Adult patient (≥ 18 years old) with clinical symptoms for more than 3 days and hospitalized. Exclusion Criteria: Refusal of the patient to participate in the study. Patient under guardianship / curatorship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The recruitment of healed patients will be carried out via the Mondor and Bichat hospitals. After information and obtaining consent at D0 : the patients will be taken from the departments of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes). Inpatients will be drawn from the wards of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes). Inpatients will be drawn from the departments of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes) at D21, then at D90 (3 months) for both groups of patients. Patients in both groups will be collected from the departments of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes) at 6 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients hospitalized for SARS-CoV-2<br>Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months . | Other: 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )<br>* Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months .<br>|
| Active Comparator: Patients who have recovered from CoV-2-SARS<br>Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months . | Other: 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)<br>* Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months .<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological memory: resolution of COVID-19 after SARS-CoV2 infection. | Biological blood collection: Blood samples taken in the course of the research will be part of a biological collection To study single-cell B and T memory cells specific for the anti-SARS-CoV-2 response and characterize somatic mutations of immunoglobulin genes and TCR, in hospitalized and symptomatic patients and in patients cured of SARS-CoV-2. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Immunity