<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/NCT04455308</url>
  </required_header>
  <id_info>
    <org_study_id>35RC20_8888_ECCES</org_study_id>
    <nct_id>NCT04455308</nct_id>
  </id_info>
  <brief_title>COVID-19 and Chilblains</brief_title>
  <acronym>ECCES</acronym>
  <official_title>Chilblains, COVID-19 and Lockdown: Epidemiologic Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      Chilblains (inflammatory lesion of the feet or hands) have been reported with an unusual&#xD;
      frequency during the confinement period, most commonly in children, teenagers and young&#xD;
      adults. The aim of the ECCES study is to find out whether these manifestations of chilblains&#xD;
      can be linked to the SARS-CoV-2 coronavirus.&#xD;
&#xD;
      For this, an epidemiologic study will compare two types of family (or more precisely people&#xD;
      who were confined together in March-April-May):&#xD;
&#xD;
        -  &quot;case family&quot; in which at least one of the members had chilblains&#xD;
&#xD;
        -  &quot;comparator family&quot; in which none of the members had chilblains Environment (home&#xD;
           lockdown) of the two types of family will be analyzed. Each member of the &quot;family&quot; will&#xD;
           be suggested doing a serological test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Actual">October 19, 2020</completion_date>
  <primary_completion_date type="Actual">October 19, 2020</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of viral exposure in &quot;case family&quot; compared to &quot;comparator family&quot;</measure>
    <time_frame>Through study completion, an average of 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of seropositivity rates in subjects with chilblains and their age-matched controls</measure>
    <time_frame>Through study completion, an average of 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of SARS-CoV-2 seropositivity rates among members of case (subject with chilblains) and control (subject without chilblains) outbreaks</measure>
    <time_frame>Through study completion, an average of 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibody avidity and differentiated IgG and IgM assay by subject in the homes</measure>
    <time_frame>Through study completion, an average of 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">269</enrollment>
  <condition>Chilblains</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Subjects with chilblains</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects without chilblains</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Biological sample collection</intervention_name>
    <description>10mL blood sample</description>
    <arm_group_label>Subjects with chilblains</arm_group_label>
    <arm_group_label>Subjects without chilblains</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &quot;case family&quot;&#xD;
&#xD;
          -  at least one of the members with chilblains&#xD;
&#xD;
          -  diagnosis of chilblains (anamnesis and pictures) written informed consent&#xD;
&#xD;
          -  &quot;comparator family&quot;&#xD;
&#xD;
          -  none of the members with chilblains&#xD;
&#xD;
          -  one member matched on age (+/- 1 year) to a patient with chilblains&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Subject legally protected (under judicial protection, guardianship), persons deprived of&#xD;
        liberty&#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>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Tours</name>
      <address>
        <city>Tours</city>
        <zip>37170</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Poizeau F, Barbarot S, Le Corre Y, Brenaut E, Samimi M, Aubert H, Toubel A, Dupuy A. Long-term Outcome of Chilblains Associated with SARS-CoV-2. Acta Derm Venereol. 2021 Dec 13;101(12):adv00614. doi: 10.2340/00015555-3930.</citation>
    <PMID>34515805</PMID>
  </results_reference>
  <results_reference>
    <citation>Poizeau F, Oger E, Barbarot S, Le Corre Y, Samimi M, Brenaut E, Aubert H, Chambrelan E, Droitcourt C, Gissot V, Heslan C, Laurent C, Martin L, Misery L, Tattevin P, Toubel A, Thibault V, Dupuy A. Chilblains during lockdown are associated with household exposure to SARS-CoV-2: a multicentre case-control study. Clin Microbiol Infect. 2022 Feb;28(2):285-291. doi: 10.1016/j.cmi.2021.09.032. Epub 2021 Oct 4.</citation>
    <PMID>34619397</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Chilblains</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/NCT04455308
org study id: 35RC20_8888_ECCES
nct id: NCT04455308
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chilblains (inflammatory lesion of the feet or hands) have been reported with an unusual
      frequency during the confinement period, most commonly in children, teenagers and young
      adults. The aim of the ECCES study is to find out whether these manifestations of chilblains
      can be linked to the SARS-CoV-2 coronavirus.

      For this, an epidemiologic study will compare two types of family (or more precisely people
      who were confined together in March-April-May):

        -  "case family" in which at least one of the members had chilblains

        -  "comparator family" in which none of the members had chilblains Environment (home
           lockdown) of the two types of family will be analyzed. Each member of the "family" will
           be suggested doing a serological test.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Level of viral exposure in "case family" compared to "comparator family"
time frame: Through study completion, an average of 3 months
measure: Comparison of seropositivity rates in subjects with chilblains and their age-matched controls
time frame: Through study completion, an average of 3 months
measure: Comparison of SARS-CoV-2 seropositivity rates among members of case (subject with chilblains) and control (subject without chilblains) outbreaks
time frame: Through study completion, an average of 3 months
measure: Antibody avidity and differentiated IgG and IgM assay by subject in the homes
time frame: Through study completion, an average of 3 months
arm group label: Subjects with chilblains
arm group type: Experimental
arm group label: Subjects without chilblains
arm group type: Active Comparator
intervention type: Diagnostic Test
intervention name: Biological sample collection
description: 10mL blood sample
arm group label: Subjects with chilblains
arm group label: Subjects without chilblains
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
citation: Poizeau F, Barbarot S, Le Corre Y, Brenaut E, Samimi M, Aubert H, Toubel A, Dupuy A. Long-term Outcome of Chilblains Associated with SARS-CoV-2. Acta Derm Venereol. 2021 Dec 13;101(12):adv00614. doi: 10.2340/00015555-3930.
PMID: 34515805
citation: Poizeau F, Oger E, Barbarot S, Le Corre Y, Samimi M, Brenaut E, Aubert H, Chambrelan E, Droitcourt C, Gissot V, Heslan C, Laurent C, Martin L, Misery L, Tattevin P, Toubel A, Thibault V, Dupuy A. Chilblains during lockdown are associated with household exposure to SARS-CoV-2: a multicentre case-control study. Clin Microbiol Infect. 2022 Feb;28(2):285-291. doi: 10.1016/j.cmi.2021.09.032. Epub 2021 Oct 4.
PMID: 34619397
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Chilblains