<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/NCT04413968</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200587</org_study_id>
    <secondary_id>2020-A01540-39</secondary_id>
    <nct_id>NCT04413968</nct_id>
  </id_info>
  <brief_title>COVID-19 Infection and Transmission in Exposed, Confined and Community-based Infants</brief_title>
  <acronym>COVIDOCRECHE</acronym>
  <official_title>Contamination and Transmission of the SARS-CoV-2 Virus in Exposed, Confined and Community-based Infants: A Cross-sectional, Multicentre, Interventional Seroprevalence Study</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>Yes</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>
      According to epidemiological models, the seroprevalence of SARS-CoV-2 infection in&#xD;
      Île-de-France as of 11 May was between 10 and 15%. Preliminary data on the number of&#xD;
      professionals evicted from nurseries on suspicion of COVID-19 (on clinical grounds) seem to&#xD;
      be of the same order of magnitude, but need to be confirmed by a biological technique.&#xD;
      Children would be susceptible to infection but often asymptomatic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SARS-CoV-2, an emerging respiratory virus of the coronavirus family, is responsible for a&#xD;
      global pandemic of which Europe has become the epicentre. Infection with the virus causes a&#xD;
      disease called COVID-19, whose expression most often includes cough, fever, fatigue, myalgia,&#xD;
      anosmia, ageusia and gastrointestinal symptoms, and which can be complicated by severe&#xD;
      pneumonia requiring resuscitation and which can lead to death. Morbidity and mortality are&#xD;
      clearly age-related and while illness and hospitalisations occur in all age groups, deaths&#xD;
      occur mostly in the older age groups.&#xD;
&#xD;
      In the absence of curative treatment and vaccination, the only real measures capable of&#xD;
      slowing the progression of the disease are large-scale social distancing measures. In analogy&#xD;
      to community-based viral epidemics such as seasonal influenza, children were initially&#xD;
      considered a potential vector of transmission, which led to the preventive measure of school&#xD;
      closures. In France, this closure came into force on 14 March 2020.&#xD;
&#xD;
      Children are considered to be little affected by the coronavirus-19 epidemic because even if&#xD;
      screening strategies differ, they represent less than 3% of the cases confirmed in the&#xD;
      various studies.&#xD;
&#xD;
      In a period of confinement and reduction in the number of children cared for, in a crèche for&#xD;
      children of healthcare workers, in a context of proximity and high risk of cross&#xD;
      transmission, the frequency of symptomatic and asymptomatic forms of SARS-Cov-2 in children&#xD;
      and staff would be comparable to the general population.&#xD;
&#xD;
      We hypothesize a susceptibility to infection in children but low transmission, which should&#xD;
      lead to a cumulative prevalence of infection among daycare staff comparable to that obtained&#xD;
      in a sample of professionals who do not come into contact with children in their work (here&#xD;
      hospital laboratory and administrative staff).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Actual">October 2, 2020</completion_date>
  <primary_completion_date type="Actual">July 2, 2020</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>
    <intervention_model_description>Cross-sectional, multi-center, non-randomized study</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the serological status/rate of past infections in the children of priority staff in the nursery during the containment period</measure>
    <time_frame>Day of intervention (1 day)</time_frame>
    <description>Proportion of children with a positive rapid serological test (presence of anti-SARS-CoV2 antibodies (IgM or IgG)).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Coronavirus</condition>
  <condition>Coronavirus Infection</condition>
  <condition>Covid19</condition>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nasopharyngeal and blood sample</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Rapid detection test</intervention_name>
    <description>Rapid serological test by taking 3 drops of blood from the fingertip via the TDR device (rapid detection test) for children, supervising nursery staff and hospital laboratory and administrative staff</description>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Nasopharyngeal swab</intervention_name>
    <description>Posterior nasopharyngeal swabbing in children</description>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Stool collection</intervention_name>
    <description>Stool collection in children</description>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Population 1 :&#xD;
&#xD;
          -  Children of priority staff welcomed in the crèche during the period of confinement,&#xD;
             i.e. from 15 March to 9 May, regardless of the length of time they are in the crèche&#xD;
             during this period and their &quot;symptomatic or not&quot; status during this period or on the&#xD;
             day of inclusion.&#xD;
&#xD;
          -  Consent of the holders of parental authority&#xD;
&#xD;
          -  Affiliated to a social security system or entitled person&#xD;
&#xD;
        Population 2 :&#xD;
&#xD;
          -  Nursery staff, regardless of their status/occupation and having had contact with the&#xD;
             children during the period of confinement regardless of how long they have been in the&#xD;
             nursery during this period and their &quot;symptomatic or not&quot; status during this period or&#xD;
             on the day of inclusion.&#xD;
&#xD;
          -  Consent to participate&#xD;
&#xD;
          -  Affiliated to a social security system or entitled person&#xD;
&#xD;
        Population 3 :&#xD;
&#xD;
          -  Hospital staff not exposed to patients and/or children, with or without children in&#xD;
             day care, working in the bacteriology, biochemistry and biological haematology&#xD;
             laboratories or in an administrative department of the participating hospitals.&#xD;
&#xD;
          -  Affiliated to a social security system or entitled person&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Population 1 :&#xD;
&#xD;
          -  Refusal to sign consent by parents&#xD;
&#xD;
          -  Clinical condition requiring urgent medical assessment (attending physician or&#xD;
             transfer to paediatric emergency)&#xD;
&#xD;
        Population 2 and 3 :&#xD;
&#xD;
          -  Refusal to sign consent for staff&#xD;
&#xD;
          -  Clinical condition requiring urgent medical evaluation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric LACHASSINNE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Jean Verdier - Service de Pédiatrie</name>
      <address>
        <city>Bondy</city>
        <zip>93143</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Jean Verdier</name>
      <address>
        <city>Bondy</city>
        <zip>93143</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Antoine béclère</name>
      <address>
        <city>Clamart</city>
        <zip>92140</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Louis Mourier</name>
      <address>
        <city>Colombes</city>
        <zip>92700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH intercommunal de Créteil</name>
      <address>
        <city>Créteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Andé Mignot</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Trousseau</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Robert debré</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Annecy Genevois</name>
      <address>
        <city>Épagny</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</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>October 23, 2020</last_update_submitted>
  <last_update_submitted_qc>October 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nursery</keyword>
  <keyword>Child</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT04413968
org study id: APHP200587
secondary id: 2020-A01540-39
nct id: NCT04413968
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
According to epidemiological models, the seroprevalence of SARS-CoV-2 infection in
      Île-de-France as of 11 May was between 10 and 15%. Preliminary data on the number of
      professionals evicted from nurseries on suspicion of COVID-19 (on clinical grounds) seem to
      be of the same order of magnitude, but need to be confirmed by a biological technique.
      Children would be susceptible to infection but often asymptomatic.
SARS-CoV-2, an emerging respiratory virus of the coronavirus family, is responsible for a
      global pandemic of which Europe has become the epicentre. Infection with the virus causes a
      disease called COVID-19, whose expression most often includes cough, fever, fatigue, myalgia,
      anosmia, ageusia and gastrointestinal symptoms, and which can be complicated by severe
      pneumonia requiring resuscitation and which can lead to death. Morbidity and mortality are
      clearly age-related and while illness and hospitalisations occur in all age groups, deaths
      occur mostly in the older age groups.

      In the absence of curative treatment and vaccination, the only real measures capable of
      slowing the progression of the disease are large-scale social distancing measures. In analogy
      to community-based viral epidemics such as seasonal influenza, children were initially
      considered a potential vector of transmission, which led to the preventive measure of school
      closures. In France, this closure came into force on 14 March 2020.

      Children are considered to be little affected by the coronavirus-19 epidemic because even if
      screening strategies differ, they represent less than 3% of the cases confirmed in the
      various studies.

      In a period of confinement and reduction in the number of children cared for, in a crèche for
      children of healthcare workers, in a context of proximity and high risk of cross
      transmission, the frequency of symptomatic and asymptomatic forms of SARS-Cov-2 in children
      and staff would be comparable to the general population.

      We hypothesize a susceptibility to infection in children but low transmission, which should
      lead to a cumulative prevalence of infection among daycare staff comparable to that obtained
      in a sample of professionals who do not come into contact with children in their work (here
      hospital laboratory and administrative staff).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Cross-sectional, multi-center, non-randomized study
primary purpose: Diagnostic
masking: None (Open Label)
measure: Assess the serological status/rate of past infections in the children of priority staff in the nursery during the containment period
time frame: Day of intervention (1 day)
description: Proportion of children with a positive rapid serological test (presence of anti-SARS-CoV2 antibodies (IgM or IgG)).
arm group label: Interventional
arm group type: Experimental
description: nasopharyngeal and blood sample
intervention type: Diagnostic Test
intervention name: Rapid detection test
description: Rapid serological test by taking 3 drops of blood from the fingertip via the TDR device (rapid detection test) for children, supervising nursery staff and hospital laboratory and administrative staff
arm group label: Interventional
intervention type: Diagnostic Test
intervention name: Nasopharyngeal swab
description: Posterior nasopharyngeal swabbing in children
arm group label: Interventional
intervention type: Diagnostic Test
intervention name: Stool collection
description: Stool collection in children
arm group label: Interventional
criteria: 
gender: All
minimum age: 1 Month
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eric LACHASSINNE, MD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: COVID-19
mesh term: Coronavirus Infections