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

Primary Purpose

COVID-19, SARS-CoV-2 Infection

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )
35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for COVID-19 focused on measuring COVID-19, Immunity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Patients hospitalized for SARS-CoV-2

    Patients who have recovered from CoV-2-SARS

    Arm Description

    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 will be sampled at inclusion (Day 0), at 3 months and at 6 months .

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 19, 2020
    Last Updated
    May 25, 2020
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04402892
    Brief Title
    COVID-19: SARS-CoV-2 Specific Memory B and T-CD4+ Cells
    Acronym
    MEMO-COV2
    Official Title
    SARS-CoV-2 Specific Memory B and T- CD4+ Cells
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2021 (Anticipated)
    Study Completion Date
    March 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19, SARS-CoV-2 Infection
    Keywords
    COVID-19, Immunity

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients hospitalized for SARS-CoV-2
    Arm Type
    Active Comparator
    Arm Description
    Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months .
    Arm Title
    Patients who have recovered from CoV-2-SARS
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Name(s)
    35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )
    Intervention Description
    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
    Intervention Name(s)
    35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)
    Intervention Description
    Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months .
    Primary Outcome Measure Information:
    Title
    Immunological memory: resolution of COVID-19 after SARS-CoV2 infection.
    Description
    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.
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MAHEVAS Matthieu, PHD
    Phone
    01 49 81 20 76
    Email
    matthieu.mahevas@aphp.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
    Citations:
    PubMed Identifier
    35764393
    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.
    Results Reference
    derived

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

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