<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/NCT04422977</url>
  </required_header>
  <id_info>
    <org_study_id>SEROPHUGAC</org_study_id>
    <nct_id>NCT04422977</nct_id>
  </id_info>
  <brief_title>Serological Study of the Exposure of Personnel to Sars-cov-2</brief_title>
  <acronym>SEROPHUGAC</acronym>
  <official_title>Serological Study of the Exposure of Personnel to Sars-cov-2 in an Urban Hospital Two Months After Managing an Influx of COVID Patients 19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Saint Joseph Saint Luc de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Saint Joseph Saint Luc de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A seroconversion test for SARS-Cov-2 will be offered to all the employees of a care&#xD;
      institution, which has treated 240 patients hospitalized for COVID disease between 28/02 and&#xD;
      30/04/2020. The seroconversion test will be with a questionnaire to determine:&#xD;
&#xD;
        -  whether the subject has shown signs of infection in the last 3 recent months&#xD;
&#xD;
        -  if the subject has been in contact with COVID-diagnosed subjects (RT-PCR diagnosis or&#xD;
           scanner) outside of the activity or within the professional activity (patient or&#xD;
           colleague)&#xD;
&#xD;
        -  Working conditions during the period&#xD;
&#xD;
        -  The level of knowledge and respect of the barrier measures practices.&#xD;
&#xD;
        -  Respect for distance during meals professional. Overall seroprevalence and stratified&#xD;
           seroprevalence by care and administrative areas will be determined.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 8, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff</measure>
    <time_frame>1 month</time_frame>
    <description>Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">900</enrollment>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>CoVID exposure</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sars-Cov-2 serology</intervention_name>
    <description>Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff</description>
    <arm_group_label>CoVID exposure</arm_group_label>
    <other_name>serology</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject who worked at Saint Joseph Saint Luke's Hospital during the epidemic wave&#xD;
             (male or female).&#xD;
&#xD;
               -  Free and informed consent&#xD;
&#xD;
               -  Social security affiliation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject refusal&#xD;
&#xD;
          -  Subject on leave during the entire period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04422977
org study id: SEROPHUGAC
nct id: NCT04422977
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A seroconversion test for SARS-Cov-2 will be offered to all the employees of a care
      institution, which has treated 240 patients hospitalized for COVID disease between 28/02 and
      30/04/2020. The seroconversion test will be with a questionnaire to determine:

        -  whether the subject has shown signs of infection in the last 3 recent months

        -  if the subject has been in contact with COVID-diagnosed subjects (RT-PCR diagnosis or
           scanner) outside of the activity or within the professional activity (patient or
           colleague)

        -  Working conditions during the period

        -  The level of knowledge and respect of the barrier measures practices.

        -  Respect for distance during meals professional. Overall seroprevalence and stratified
           seroprevalence by care and administrative areas will be determined.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff
time frame: 1 month
description: Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff
arm group label: CoVID exposure
arm group type: Other
intervention type: Diagnostic Test
intervention name: Sars-Cov-2 serology
description: Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff
arm group label: CoVID exposure
other name: serology
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor