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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19 SARS-CoV-2 Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients hospitalized for SARS-CoV-2

Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months .

Group Type ACTIVE_COMPARATOR

35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )

Intervention Type OTHER

Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months .

Patients who have recovered from CoV-2-SARS

Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months .

Group Type ACTIVE_COMPARATOR

35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)

Intervention Type OTHER

Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months .

Interventions

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35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )

Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months .

Intervention Type OTHER

35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)

Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months .

Intervention Type OTHER

Eligibility Criteria

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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.