Clinical trial NCT04402892: COVID-19: SARS-CoV-2 Specific Memory B and T-CD4+ Cells
Official title: SARS-CoV-2 Specific Memory B and T- CD4+ Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
SARS-CoV-2 Infection
Keywords: COVID-19
Immunity
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Immunological memory: resolution of COVID-19 after SARS-CoV2 infection.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Attias P, Azzaoui I, El Karoui K, de La Selle A, Sokal A, Chappert P, Grimbert P, Fernandez I, Bouvier M, Samson C, Dahmane D, Rieu P, Nizard P, Fourati S, Sakhi H, Mahevas M; Mondor NephroCov Study Group. Immune Responses after a Third Dose of mRNA Vaccine Differ in Virus-Naive versus SARS-CoV-2- Recovered Dialysis Patients. Clin J Am Soc Nephrol. 2022 Jul;17(7):1008-1016. doi: 10.2215/CJN.00830122. Epub 2022 Jun 28.