<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/NCT04481529</url>
  </required_header>
  <id_info>
    <org_study_id>87RI20_0049/SEROCO</org_study_id>
    <nct_id>NCT04481529</nct_id>
  </id_info>
  <brief_title>COVID-19 Serological Status of Hospital Staff Working or Not in the COVID-19 Sector</brief_title>
  <acronym>SEROCO</acronym>
  <official_title>Study of the COVID-19 Serological Status of Hospital Staff Working or Not in the COVID-19 Sector in 3 French Regions Facing the COVID-19 Epidemic With Varying Degrees of Intensity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Limoges</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Limoges</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>
      Hospital staff, on the front line in the COVID-19 crisis, have many questions about the risk&#xD;
      that they have been infected with this potentially fatal virus. These questions of course&#xD;
      primarily concern caregivers working in sectors dedicated to COVID-19 patients, whether they&#xD;
      are resuscitating or not, but also those in non-COVID-19 sectors, or even staff without&#xD;
      direct contact with patients. In addition, depending on the suddenness and intensity of this&#xD;
      &quot;COVID-19 wave&quot;, these personnel have been more or less trained and sometimes exposed due to&#xD;
      the dire lack of protective equipment. In some countries such as Great Britain, this has&#xD;
      resulted in significant absenteeism, a source of deepening the shortage of caregivers.&#xD;
&#xD;
      This proportion of contaminated caregivers has not been evaluated on the whole of French&#xD;
      territory. Studies from other countries suggest figures ranging from 1.5% in China to 20% in&#xD;
      Italy. It is therefore impossible to rely on such variable data to have a reliable estimate.&#xD;
&#xD;
      Since june 2020, all staff in French health establishments could benefit a serological test.&#xD;
&#xD;
      Thus, in this epidemiological study, we propose to rely on this institutional serological&#xD;
      screening to describe the link between seroconversion of hospital staff, regional intensity&#xD;
      of the epidemic, and sectors of activity (COVID-19 sectors, non-COVID-19 caregivers ,&#xD;
      non-COVID-19 non-caregivers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Anticipated">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with a COVID-19 seroconversion</measure>
    <time_frame>through study completion, an average of 5 month</time_frame>
    <description>Number of subjects with a COVID-19 seroconversion fixed by the presence of IgG + in serology according to the service (COVID19 +, COVID19- caregiver, COVID- non-caregiver).</description>
  </primary_outcome>
  <enrollment type="Actual">1576</enrollment>
  <condition>Infection Viral</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health Questionnaire</intervention_name>
    <description>Completion of a short questionnaire noting the result of the serology and looking for elements in favor of exposure to the virus, whether professional or extra-professional.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospital staff&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospital staff from Argenteuil, Belfort, Dijon and Limoges hospitals.&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Participation agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Protected persons&#xD;
&#xD;
          -  Refusal of participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>CH Argenteuil - Service de Réanimation</name>
      <address>
        <city>Argenteuil</city>
        <zip>95107</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Belfort</name>
      <address>
        <city>Belfort</city>
        <zip>90000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dijon - Serve de Réanimation</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Limoges</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</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>Virus Diseases</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/NCT04481529
org study id: 87RI20_0049/SEROCO
nct id: NCT04481529
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hospital staff, on the front line in the COVID-19 crisis, have many questions about the risk
      that they have been infected with this potentially fatal virus. These questions of course
      primarily concern caregivers working in sectors dedicated to COVID-19 patients, whether they
      are resuscitating or not, but also those in non-COVID-19 sectors, or even staff without
      direct contact with patients. In addition, depending on the suddenness and intensity of this
      "COVID-19 wave", these personnel have been more or less trained and sometimes exposed due to
      the dire lack of protective equipment. In some countries such as Great Britain, this has
      resulted in significant absenteeism, a source of deepening the shortage of caregivers.

      This proportion of contaminated caregivers has not been evaluated on the whole of French
      territory. Studies from other countries suggest figures ranging from 1.5% in China to 20% in
      Italy. It is therefore impossible to rely on such variable data to have a reliable estimate.

      Since june 2020, all staff in French health establishments could benefit a serological test.

      Thus, in this epidemiological study, we propose to rely on this institutional serological
      screening to describe the link between seroconversion of hospital staff, regional intensity
      of the epidemic, and sectors of activity (COVID-19 sectors, non-COVID-19 caregivers ,
      non-COVID-19 non-caregivers.
observational model: Case-Only
time perspective: Prospective
measure: Number of subjects with a COVID-19 seroconversion
time frame: through study completion, an average of 5 month
description: Number of subjects with a COVID-19 seroconversion fixed by the presence of IgG + in serology according to the service (COVID19 +, COVID19- caregiver, COVID- non-caregiver).
intervention type: Other
intervention name: Health Questionnaire
description: Completion of a short questionnaire noting the result of the serology and looking for elements in favor of exposure to the virus, whether professional or extra-professional.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Virus Diseases