<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/NCT04490811</url>
  </required_header>
  <id_info>
    <org_study_id>HNeckerNM</org_study_id>
    <nct_id>NCT04490811</nct_id>
  </id_info>
  <brief_title>Seroprevalence and Immunoprotection Against COVID-19 in Parisian Children</brief_title>
  <acronym>AP-PEDCOVID</acronym>
  <official_title>Seroprevalence and Immunoprotection Against SARS-CoV2 in Children Hospitalized in Paris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Necker-Enfants Malades</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Necker-Enfants Malades</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 paediatric population present mild or asymptomatic form of SARS-CoV-2 infection. This&#xD;
      study asses the frequency of patients with SARS-CoV2 Antibodies (Ab) (seroprevalence) and the&#xD;
      neutralizing typology of those Ab (immunoprotection) in children from 7 days to 18 years of&#xD;
      age hospitalized for no more than 4 days and whose clinical status requires blood sample&#xD;
      regardless of the symptoms Patients are included on a given day, after information, before&#xD;
      blood sampling performed as part of the care. 500 µL of sera, normally discarded will be kept&#xD;
      to perform SARS-Cov2 serology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background of the study:&#xD;
&#xD;
      The fraction of undiagnosed cases is a critical epidemiological characteristic that modulates&#xD;
      the epidemic potential of SARS-CoV-2 emerging respiratory virus. These subjects most often&#xD;
      present themselves in benign or totally asymptomatic form, although they are likely to spread&#xD;
      the virus in the general population. The containment strategy was implemented in France to&#xD;
      reverse the exponential epidemic growth of infection.&#xD;
&#xD;
      A crucial issue is the specific study of the paediatric population because the prevalence of&#xD;
      symptomatic infections is low and children are mostly mild and under-diagnosed. Children&#xD;
      could frequently be asymptomatic carriers and act as a real reservoir for the spread of the&#xD;
      virus. In these &quot;sub-symptomatic&quot; carriers, the viral load may be low, and it is possible&#xD;
      that PCR nasal tests may be defective. The serological study is therefore essential because&#xD;
      it will inform us about the speed and effectiveness of seroconversion and therefore about the&#xD;
      immunoprotection of this subpopulation.&#xD;
&#xD;
      The rationale for the study is that the proportion of children who have developed&#xD;
      immunoprotection is decisive in defining measures to control the epidemic. It is essential to&#xD;
      assess the prevalence and typology of antibody responses in this population and to follow&#xD;
      kinetics over time.&#xD;
&#xD;
      The many emerging atypical forms and in particular the post-infectious kawasaki-like forms&#xD;
      have a very particular immunopathological profile that provides information on the natural&#xD;
      history of the disease.&#xD;
&#xD;
      Main objectives of the study to assess the prevalence of seroconversion (seroprevalence) in a&#xD;
      pediatric population sample to study the immunopathological profile of clinical forms&#xD;
      attributed to SARS-CoV-2 infection&#xD;
&#xD;
      Design of the study Patients are included on a given day, after information, before blood&#xD;
      sampling performed as part of the care. 500 µL of sera, normally discarded will be kept to&#xD;
      perform SARS-Cov2 serology. According to data currently collected in France, 5% of children&#xD;
      taken from symptoms are infected. Given that nasopharyngeal testing is lacking in this&#xD;
      pediatric population, we anticipate an increase in the number of subjects who have been&#xD;
      infected or have an ongoing infection at least 10%. A sample of 800 subjects will therefore&#xD;
      include at least 80 children with infection.&#xD;
&#xD;
      A questionnaire will extract relevant variables to this project:&#xD;
&#xD;
        -  Any symptoms of the index case or his family since December 2019 consistent with&#xD;
           COVID-19&#xD;
&#xD;
        -  Comorbidities and treatment&#xD;
&#xD;
        -  Reason for hospitalization&#xD;
&#xD;
        -  History of contact case&#xD;
&#xD;
        -  Clinical signs on the day of collection&#xD;
&#xD;
        -  Result of RT-PCT SARS-CoV2 nasopharyngeal if made in the index case&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 9, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>serological test</measure>
    <time_frame>48 weeks</time_frame>
    <description>Ab against SARS-CoV-2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>neutralizing Ab</measure>
    <time_frame>48 weeks</time_frame>
    <description>activity of the antibodies against SARS-CoV2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immuno phenotyping</measure>
    <time_frame>48 weeks</time_frame>
    <description>Lymphocyte response phenotyping</description>
  </secondary_outcome>
  <enrollment type="Anticipated">800</enrollment>
  <condition>COVID-19</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention. observational cohort study</intervention_name>
    <description>blood sampling is part of care</description>
    <other_name>no intervention</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All hospitalized children at Assistance Publique Hôpitaux de Paris&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any child over 7 days and under 18 years of age who has been hospitalized for no more&#xD;
             than 4 days and who has a blood sample regardless of the symptoms;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any child under 7 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Days</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Philippe Tourenne</last_name>
    <phone>1 58 41 12 87</phone>
    <phone_ext>+33</phone_ext>
    <email>philippe.tourenne@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Necker Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>SERMET Isabelle, Professor</last_name>
      <phone>01 44 49 48 87</phone>
      <email>isabelle.sermet@aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>SERMET Isabelle, Professor</last_name>
      <phone>01 44 49 48 87</phone>
      <email>isabelle.sermet@nck.aphp.fr</email>
    </contact_backup>
    <investigator>
      <last_name>SERMET Isabelle, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Necker-Enfants Malades</investigator_affiliation>
    <investigator_full_name>Isabelle Sermet-Gaudelus</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04490811
org study id: HNeckerNM
nct id: NCT04490811
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The paediatric population present mild or asymptomatic form of SARS-CoV-2 infection. This
      study asses the frequency of patients with SARS-CoV2 Antibodies (Ab) (seroprevalence) and the
      neutralizing typology of those Ab (immunoprotection) in children from 7 days to 18 years of
      age hospitalized for no more than 4 days and whose clinical status requires blood sample
      regardless of the symptoms Patients are included on a given day, after information, before
      blood sampling performed as part of the care. 500 µL of sera, normally discarded will be kept
      to perform SARS-Cov2 serology.
Background of the study:

      The fraction of undiagnosed cases is a critical epidemiological characteristic that modulates
      the epidemic potential of SARS-CoV-2 emerging respiratory virus. These subjects most often
      present themselves in benign or totally asymptomatic form, although they are likely to spread
      the virus in the general population. The containment strategy was implemented in France to
      reverse the exponential epidemic growth of infection.

      A crucial issue is the specific study of the paediatric population because the prevalence of
      symptomatic infections is low and children are mostly mild and under-diagnosed. Children
      could frequently be asymptomatic carriers and act as a real reservoir for the spread of the
      virus. In these "sub-symptomatic" carriers, the viral load may be low, and it is possible
      that PCR nasal tests may be defective. The serological study is therefore essential because
      it will inform us about the speed and effectiveness of seroconversion and therefore about the
      immunoprotection of this subpopulation.

      The rationale for the study is that the proportion of children who have developed
      immunoprotection is decisive in defining measures to control the epidemic. It is essential to
      assess the prevalence and typology of antibody responses in this population and to follow
      kinetics over time.

      The many emerging atypical forms and in particular the post-infectious kawasaki-like forms
      have a very particular immunopathological profile that provides information on the natural
      history of the disease.

      Main objectives of the study to assess the prevalence of seroconversion (seroprevalence) in a
      pediatric population sample to study the immunopathological profile of clinical forms
      attributed to SARS-CoV-2 infection

      Design of the study Patients are included on a given day, after information, before blood
      sampling performed as part of the care. 500 µL of sera, normally discarded will be kept to
      perform SARS-Cov2 serology. According to data currently collected in France, 5% of children
      taken from symptoms are infected. Given that nasopharyngeal testing is lacking in this
      pediatric population, we anticipate an increase in the number of subjects who have been
      infected or have an ongoing infection at least 10%. A sample of 800 subjects will therefore
      include at least 80 children with infection.

      A questionnaire will extract relevant variables to this project:

        -  Any symptoms of the index case or his family since December 2019 consistent with
           COVID-19

        -  Comorbidities and treatment

        -  Reason for hospitalization

        -  History of contact case

        -  Clinical signs on the day of collection

        -  Result of RT-PCT SARS-CoV2 nasopharyngeal if made in the index case
observational model: Cohort
time perspective: Retrospective
measure: serological test
time frame: 48 weeks
description: Ab against SARS-CoV-2
measure: neutralizing Ab
time frame: 48 weeks
description: activity of the antibodies against SARS-CoV2
measure: Immuno phenotyping
time frame: 48 weeks
description: Lymphocyte response phenotyping
intervention type: Other
intervention name: no intervention. observational cohort study
description: blood sampling is part of care
other name: no intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Days
maximum age: 18 Years
healthy volunteers: No
last name: Philippe Tourenne
phone: 1 58 41 12 87
phone ext: +33
email: philippe.tourenne@aphp.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hôpital Necker-Enfants Malades
investigator full name: Isabelle Sermet-Gaudelus
investigator title: Professor
mesh term: COVID-19
sharing ipd: No