<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/NCT04416893</url>
  </required_header>
  <id_info>
    <org_study_id>COVILLE2</org_study_id>
    <nct_id>NCT04416893</nct_id>
  </id_info>
  <brief_title>Part 2 on the Study Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children (COVILLE2) (WHO)</brief_title>
  <acronym>COVILLE2</acronym>
  <official_title>Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care-Part 2 After the Lifting of the Lockdown</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Association Clinique Thérapeutique Infantile du val de Marne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>GPIP</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Francophone Pediatric Resuscitation and Emergency Group (GFRUP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</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>
      France and in particular the paris area was one of the countries most affected by the&#xD;
      pandemic Covid19.&#xD;
&#xD;
      School closures and a generalized lockdown of the population were instituted in France from&#xD;
      17 March 2020 to 10 May 2020. Schools and nurseries have reopened partially since 11 May&#xD;
      2020. From 2 June, this reopening is more widespread. By combining the search for SARS-Cov2&#xD;
      viruses by PCR and micro-method serology we will be able to evaluate both the infection at a&#xD;
      given time and also older contact with SARS-CoV2.&#xD;
&#xD;
      The temporal knowledge of the prevalence of SARS-Cov2 carriage and the serological status&#xD;
      (IgM and IgG) after return to the community are crucial information to evaluate the speed of&#xD;
      spread of the virus in children. This is the objective of COVILLE2, phase 2 of the COVILLE&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    With the rapid evolution of COVID-19, the objective was no longer relevant&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 2020</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Anticipated">January 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of asymptomatic children or children with mild respiratory symptoms</measure>
    <time_frame>At inclusion</time_frame>
    <description>Proportion of asymptomatic children or children with mild respiratory symptoms (mildly-symptomatic children) with a positive SARS-Cov2 Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on rhino pharyngeal swab or/and IgM/IgG positive serology in Paris area</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cov2-SARS cases by age</measure>
    <time_frame>At inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cov2-SARS cases by symptoms</measure>
    <time_frame>At inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral load</measure>
    <time_frame>At inclusion</time_frame>
    <description>The viral load of children with SARS-Cov2 positive Reverse Transcriptase Polymerase Chain Reaction depending on the symptoms and the age of the patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of anti-SARS-CoV-2 antibodies (IgM and IgG) by the rapid serological test</measure>
    <time_frame>At inclusion</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID19</condition>
  <arm_group>
    <arm_group_label>Children under 15 years of age in a community</arm_group_label>
    <description>Children under 15 years of age in a community : kindergarten, school, college, holiday center, etc.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>RT-PCR SARS-Cov2</intervention_name>
    <description>nasopharyngeal swab will be taken for detection of SARS-CoV-2 by RT-PCR</description>
    <arm_group_label>Children under 15 years of age in a community</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sars-Cov2 serology</intervention_name>
    <description>A microsample of blood will be taken for serology</description>
    <arm_group_label>Children under 15 years of age in a community</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children under 15 years of age in a community (kindergarten, school, college, holiday&#xD;
        centre, etc.).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Birth to 15 years old&#xD;
&#xD;
          -  taking over the community (kindergarten, school, college, holiday centre, etc.) for at&#xD;
             least 1 week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 25, 2021</last_update_submitted>
  <last_update_submitted_qc>May 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RT-PCR SARS-CoV-2</keyword>
  <keyword>Serology SARS-CoV-2</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/NCT04416893
org study id: COVILLE2
nct id: NCT04416893
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
France and in particular the paris area was one of the countries most affected by the
      pandemic Covid19.

      School closures and a generalized lockdown of the population were instituted in France from
      17 March 2020 to 10 May 2020. Schools and nurseries have reopened partially since 11 May
      2020. From 2 June, this reopening is more widespread. By combining the search for SARS-Cov2
      viruses by PCR and micro-method serology we will be able to evaluate both the infection at a
      given time and also older contact with SARS-CoV2.

      The temporal knowledge of the prevalence of SARS-Cov2 carriage and the serological status
      (IgM and IgG) after return to the community are crucial information to evaluate the speed of
      spread of the virus in children. This is the objective of COVILLE2, phase 2 of the COVILLE
      study.
observational model: Cohort
time perspective: Prospective
measure: Proportion of asymptomatic children or children with mild respiratory symptoms
time frame: At inclusion
description: Proportion of asymptomatic children or children with mild respiratory symptoms (mildly-symptomatic children) with a positive SARS-Cov2 Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on rhino pharyngeal swab or/and IgM/IgG positive serology in Paris area
measure: Cov2-SARS cases by age
time frame: At inclusion
measure: Cov2-SARS cases by symptoms
time frame: At inclusion
measure: Viral load
time frame: At inclusion
description: The viral load of children with SARS-Cov2 positive Reverse Transcriptase Polymerase Chain Reaction depending on the symptoms and the age of the patients
measure: Presence of anti-SARS-CoV-2 antibodies (IgM and IgG) by the rapid serological test
time frame: At inclusion
arm group label: Children under 15 years of age in a community
description: Children under 15 years of age in a community : kindergarten, school, college, holiday center, etc.
intervention type: Diagnostic Test
intervention name: RT-PCR SARS-Cov2
description: nasopharyngeal swab will be taken for detection of SARS-CoV-2 by RT-PCR
arm group label: Children under 15 years of age in a community
intervention type: Diagnostic Test
intervention name: Sars-Cov2 serology
description: A microsample of blood will be taken for serology
arm group label: Children under 15 years of age in a community
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: No