MEMO-COV2: COVID-19: SARS-CoV-2 Specific Memory B and T-CD4+ Cells

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT04402892

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 SARS-CoV-2 Infection	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)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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 .	Other: 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 .
Active Comparator: 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 .	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 .

Arm

Intervention/Treatment

Active Comparator: 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 .

Other: 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 .

Active Comparator: 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 .

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 .

Outcome Measures

Primary Outcome Measures

Immunological memory: resolution of COVID-19 after SARS-CoV2 infection. [5 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT04402892

Other Study ID Numbers:

APHP200551

First Posted:

May 27, 2020

Last Update Posted:

May 27, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

COVID-19

Immunity

Additional relevant MeSH terms:

COVID-19

Lithium Carbonate

Study Results

No Results Posted as of May 27, 2020