<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/NCT04442087</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200627</org_study_id>
    <secondary_id>2020-A01480-39</secondary_id>
    <nct_id>NCT04442087</nct_id>
  </id_info>
  <brief_title>Study of Seroprevalence of Anti-SARS-CoV2 Among Children of Hospital Workers in AP-HP</brief_title>
  <acronym>FamilyPEDCOVID</acronym>
  <official_title>Seroprevalence of Anti-SARS-CoV2 Among Children According to Parents' SARS-CoV2 Serological Status. Study in a Hospital Population Assistance Publique-Hôpitaux Paris</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 purpose of this study is to define seroprevalence of anti-SARS-CoV2 among children of&#xD;
      Hospital Workers in APHP, particularly exposed population, according to parents' SARS-CoV2&#xD;
      serological status.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seroprevalence of antibodies anti- SARS Cov2 in blood sample of children of Hospital workers</measure>
    <time_frame>at inclusion</time_frame>
    <description>Percentage of children with seropositive in blood sample according to parents' SARS Cov2 serological status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprevalence of antibodies anti- SARS Cov2 in saliva sample of children of Hospital workers</measure>
    <time_frame>at inclusion</time_frame>
    <description>Percentage of children with seropositive according in saliva sample to parents' SARS Cov2 serological status</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Asymptomatic Children with a positive seroloy</measure>
    <time_frame>At inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of severely symptomatic Children with a positive serology</measure>
    <time_frame>At inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of different clinical symptoms in children with a positive serology</measure>
    <time_frame>At inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serological result of each member of the family</measure>
    <time_frame>At inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of spouses of hospital workers with a positive serology</measure>
    <time_frame>At inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Asymptomatic spouses of hospital workers with a positive serology</measure>
    <time_frame>At inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of severely symptomatic spouses of hospital workers with a positive serology</measure>
    <time_frame>At inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Serological result obtained in blood and saliva samples</measure>
    <time_frame>At inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk factors based on a questionnaire for children and adults</measure>
    <time_frame>At inclusion</time_frame>
    <description>the following factors will be of particular importance: characteristics and composition of the family home, barrier measures, medical history and comorbidities.</description>
  </secondary_outcome>
  <enrollment type="Actual">563</enrollment>
  <condition>SARS-CoV2</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Serology SARS-CoV2</intervention_name>
    <description>Collect serum for Serology SARS-CoV2 at inclusion</description>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>Collect clinical and demographic data, habitus, Lifestyle Counseling at inclusion</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Hospital workers :&#xD;
&#xD;
          1. Individuals aged over 18, having a professional activity at the APHP (employees,&#xD;
             interns, volunteers)&#xD;
&#xD;
          2. Affiliated to a social security regimen&#xD;
&#xD;
          3. Have at least one child under the age of 18 living in the same house.&#xD;
&#xD;
          4. have signed consent&#xD;
&#xD;
        Child (ren), spouse and other member (s) residing at household:&#xD;
&#xD;
        Child (ren), spouse and any other member residing in the household of a professional of the&#xD;
        Paris Center Hospitals meeting the inclusion criteria above.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Refuse to participate in research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Solen KERNEIS, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Flore ROZENBERG, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean-Marc TRELUYER, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre d'investigation clinique (CIC) Necker Cochin in Necker Children's Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>November 19, 2021</last_update_submitted>
  <last_update_submitted_qc>November 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV2</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Serology</keyword>
  <keyword>Hospital workers</keyword>
  <keyword>Children</keyword>
  <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/NCT04442087
org study id: APHP200627
secondary id: 2020-A01480-39
nct id: NCT04442087
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to define seroprevalence of anti-SARS-CoV2 among children of
      Hospital Workers in APHP, particularly exposed population, according to parents' SARS-CoV2
      serological status.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Seroprevalence of antibodies anti- SARS Cov2 in blood sample of children of Hospital workers
time frame: at inclusion
description: Percentage of children with seropositive in blood sample according to parents' SARS Cov2 serological status
measure: Seroprevalence of antibodies anti- SARS Cov2 in saliva sample of children of Hospital workers
time frame: at inclusion
description: Percentage of children with seropositive according in saliva sample to parents' SARS Cov2 serological status
measure: Number of Asymptomatic Children with a positive seroloy
time frame: At inclusion
measure: Number of severely symptomatic Children with a positive serology
time frame: At inclusion
measure: Prevalence of different clinical symptoms in children with a positive serology
time frame: At inclusion
measure: Serological result of each member of the family
time frame: At inclusion
measure: Number of spouses of hospital workers with a positive serology
time frame: At inclusion
measure: Number of Asymptomatic spouses of hospital workers with a positive serology
time frame: At inclusion
measure: Number of severely symptomatic spouses of hospital workers with a positive serology
time frame: At inclusion
measure: Comparison of Serological result obtained in blood and saliva samples
time frame: At inclusion
measure: Risk factors based on a questionnaire for children and adults
time frame: At inclusion
description: the following factors will be of particular importance: characteristics and composition of the family home, barrier measures, medical history and comorbidities.
intervention type: Biological
intervention name: Serology SARS-CoV2
description: Collect serum for Serology SARS-CoV2 at inclusion
intervention type: Behavioral
intervention name: Data collection
description: Collect clinical and demographic data, habitus, Lifestyle Counseling at inclusion
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Solen KERNEIS, MD
role: Study Director
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Flore ROZENBERG, MD, PhD
role: Study Director
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Jean-Marc TRELUYER, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No