<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04402892</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200551</org_study_id>
    <nct_id>NCT04402892</nct_id>
  </id_info>
  <brief_title>COVID-19: SARS-CoV-2 Specific Memory B and T-CD4+ Cells</brief_title>
  <acronym>MEMO-COV2</acronym>
  <official_title>SARS-CoV-2 Specific Memory B and T- CD4+ Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current pandemic caused by the newly identified coronavirus responsible for COVID-19 is a&#xD;
      major threat to our populations and societies.&#xD;
&#xD;
      Hypothesis/Objective The acquisition of protective immunity at the level of the individual,&#xD;
      either through vaccination or natural resolution of the infection, progressively leads at the&#xD;
      level of the population to the reduction of the fraction of the population that can be&#xD;
      productively infected and transmit the virus, hence, leading to the diminution of the rate of&#xD;
      transmission, a phenomenon called herd immunity. Herd immunity was proposed as a strategy to&#xD;
      control the infection. However, it remains difficult to model group immunity given the&#xD;
      limited knowledge of the interaction between the host immune system with the virus, whose&#xD;
      capacity to evolve in face of a neutralizing response is also not known. It is therefore&#xD;
      important to acquire a better knowledge of the immunological memory that ensures the&#xD;
      resolution of COVID-19 after SARS-CoV2 infection.&#xD;
&#xD;
      Method To study single-cell B and T memory cells specific for the anti-SARS-CoV-2 response&#xD;
      and characterize somatic mutations of immunoglobulin genes and TCR, in hospitalized and&#xD;
      symptomatic patients and in patients cured of SARS-CoV-2.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">March 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The recruitment of healed patients will be carried out via the Mondor and Bichat hospitals.&#xD;
After information and obtaining consent at D0 :&#xD;
the patients will be taken from the departments of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes).&#xD;
Inpatients will be drawn from the wards of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes).&#xD;
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.&#xD;
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.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immunological memory: resolution of COVID-19 after SARS-CoV2 infection.</measure>
    <time_frame>5 years</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV-2 Infection</condition>
  <arm_group>
    <arm_group_label>Patients hospitalized for SARS-CoV-2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients who have recovered from CoV-2-SARS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months .</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )</intervention_name>
    <description>Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months .</description>
    <arm_group_label>Patients hospitalized for SARS-CoV-2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)</intervention_name>
    <description>Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months .</description>
    <arm_group_label>Patients who have recovered from CoV-2-SARS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have recovered from CoV-2-SARS&#xD;
&#xD;
          -  Adult patient (≥ 18 years old) with a positive SARS-CoV-2 PCR.&#xD;
&#xD;
          -  Adult patient (≥ 18 years old) who has recovered from SARS-CoV-2 i.e. has been free of&#xD;
             clinical symptoms for more than 15 days and has not been hospitalized and for less&#xD;
             than 6 weeks.&#xD;
&#xD;
          -  Patient affiliated to a social security scheme.&#xD;
&#xD;
        Patients hospitalized for SARS-CoV-2&#xD;
&#xD;
          -  Adult patient (≥ 18 years old) with a positive SARS-CoV-2 PCR.&#xD;
&#xD;
          -  Adult patient (≥ 18 years old) with clinical symptoms for more than 3 days and&#xD;
             hospitalized.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient to participate in the study.&#xD;
&#xD;
          -  Patient under guardianship / curatorship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>MAHEVAS Matthieu, PHD</last_name>
    <phone>01 49 81 20 76</phone>
    <email>matthieu.mahevas@aphp.fr</email>
  </overall_contact>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Immunity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lithium Carbonate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04402892
org study id: APHP200551
nct id: NCT04402892
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
primary purpose: Basic Science
masking: None (Open Label)
measure: Immunological memory: resolution of COVID-19 after SARS-CoV2 infection.
time frame: 5 years
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.
arm group label: Patients hospitalized for SARS-CoV-2
arm group type: Active Comparator
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 group label: Patients who have recovered from CoV-2-SARS
arm group type: Active Comparator
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: 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )
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 group label: Patients hospitalized for SARS-CoV-2
intervention type: Other
intervention name: 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)
description: Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months .
arm group label: Patients who have recovered from CoV-2-SARS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MAHEVAS Matthieu, PHD
phone: 01 49 81 20 76
email: matthieu.mahevas@aphp.fr
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Lithium Carbonate
sharing ipd: No
ipd description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION