<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/NCT04429724</url>
  </required_header>
  <id_info>
    <org_study_id>RIPH_2020_8</org_study_id>
    <nct_id>NCT04429724</nct_id>
  </id_info>
  <brief_title>Health Professional Exposure Assessment to Covid-19</brief_title>
  <acronym>SERODRON</acronym>
  <official_title>Health Professional Exposure Assessment to Covid-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tourcoing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tourcoing 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>
      Understanding the SARS-Cov2 epidemic is a major public health issue, both in the community&#xD;
      and in the hospital sector. Because of their central position in the management of patients&#xD;
      infected with COVID-19, hospital staff may be considered at high risk of infection. The&#xD;
      development of serological tests makes it possible to reliably document a contamination,&#xD;
      symptomatic or not, that is more than 3 weeks old. These tests, combined with clinical&#xD;
      questioning of the symptoms, make it possible to determine the proportion of asymptomatic&#xD;
      infections whose impact in the transmission of this disease appears to be major. The duration&#xD;
      of the presence of the antibodies that are hoped to neutralize after infection with CoV2-SARS&#xD;
      remains uncertain. Documenting the evolution of antibody levels and their monitoring in a&#xD;
      population at high risk of re-exposure to CoV2-SARS is a major issue in understanding this&#xD;
      disease and in assessing the risk of infection among healthcare workers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, prospective, interventional, low-risk, low-constraint, biological&#xD;
      collection study to assess the exposure of health care workers to COVID-19.&#xD;
&#xD;
      Three blood samples will be taken at day 1, month 3 and month 6. The blood samples will be&#xD;
      stored in a serum biological collection. A prospective data collection will be set up at the&#xD;
      level of symptoms and co-morbidities at each collection at D1, M3 and M6.&#xD;
&#xD;
      In the event of the appearance of symptoms between samples, a self-questionnaire will be&#xD;
      completed by the participating personnel as well as an invitation to screening by RT-PCR SARS&#xD;
      Cov2 according to standard practices in force at the national level as well as an additional&#xD;
      serological test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Actual">March 16, 2021</completion_date>
  <primary_completion_date type="Actual">March 16, 2021</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of contaminated personnel</measure>
    <time_frame>day 1</time_frame>
    <description>Number of contaminated personnel by occupational category and department on day 1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of contaminated personnel</measure>
    <time_frame>month 3</time_frame>
    <description>Number of contaminated personnel by professional category and by service at month 3 a by serological test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of contaminated personnel</measure>
    <time_frame>month 6</time_frame>
    <description>Number of contaminated personnel by professional category and by service at month 6 a by serological test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of symptomatic staff by occupational category and service</measure>
    <time_frame>month 3</time_frame>
    <description>Number of symptomatic staff by occupational category and service at Month 3 with positive RT-PCR Cov2 SARS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of symptomatic staff by occupational category and service</measure>
    <time_frame>month 6</time_frame>
    <description>Number of symptomatic staff by occupational category and service at Month 6 with positive RT-PCR Cov2 SARS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of contaminated personnel with effective protection</measure>
    <time_frame>evolution at day 1, month 3 and month 6</time_frame>
    <description>Number of contaminated personnel with effective protection: evolution of the antibody index at day 1, month 3 and month 6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies</measure>
    <time_frame>month 6</time_frame>
    <description>comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies between two stitch dates.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2129</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>health workers at hospital</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three blood samples will be taken at day 1, month 3 and month 6. A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Diagnostic test Covid-19</intervention_name>
    <description>Three blood samples will be taken at day 1, month 3 and month 6 A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.</description>
    <arm_group_label>health workers at hospital</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Staff on duty in the health facility&#xD;
&#xD;
          -  Eligible to be drawn&#xD;
&#xD;
          -  Beneficiary subject affiliated or entitled to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor patient&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Patient under guardianship&#xD;
&#xD;
          -  Patient under guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>PATOZ Pierre, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH Tourcoing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CH Roubaix</name>
      <address>
        <city>Roubaix</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Tourcoing</name>
      <address>
        <city>Tourcoing</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Wasquehal</name>
      <address>
        <city>Wasquehal</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Wattrelos</name>
      <address>
        <city>Wattrelos</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>May 9, 2022</last_update_submitted>
  <last_update_submitted_qc>May 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</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>
  </condition_browse>
  <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/NCT04429724
org study id: RIPH_2020_8
nct id: NCT04429724
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Understanding the SARS-Cov2 epidemic is a major public health issue, both in the community
      and in the hospital sector. Because of their central position in the management of patients
      infected with COVID-19, hospital staff may be considered at high risk of infection. The
      development of serological tests makes it possible to reliably document a contamination,
      symptomatic or not, that is more than 3 weeks old. These tests, combined with clinical
      questioning of the symptoms, make it possible to determine the proportion of asymptomatic
      infections whose impact in the transmission of this disease appears to be major. The duration
      of the presence of the antibodies that are hoped to neutralize after infection with CoV2-SARS
      remains uncertain. Documenting the evolution of antibody levels and their monitoring in a
      population at high risk of re-exposure to CoV2-SARS is a major issue in understanding this
      disease and in assessing the risk of infection among healthcare workers.
This is a multi-center, prospective, interventional, low-risk, low-constraint, biological
      collection study to assess the exposure of health care workers to COVID-19.

      Three blood samples will be taken at day 1, month 3 and month 6. The blood samples will be
      stored in a serum biological collection. A prospective data collection will be set up at the
      level of symptoms and co-morbidities at each collection at D1, M3 and M6.

      In the event of the appearance of symptoms between samples, a self-questionnaire will be
      completed by the participating personnel as well as an invitation to screening by RT-PCR SARS
      Cov2 according to standard practices in force at the national level as well as an additional
      serological test.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of contaminated personnel
time frame: day 1
description: Number of contaminated personnel by occupational category and department on day 1.
measure: Number of contaminated personnel
time frame: month 3
description: Number of contaminated personnel by professional category and by service at month 3 a by serological test
measure: Number of contaminated personnel
time frame: month 6
description: Number of contaminated personnel by professional category and by service at month 6 a by serological test
measure: Number of symptomatic staff by occupational category and service
time frame: month 3
description: Number of symptomatic staff by occupational category and service at Month 3 with positive RT-PCR Cov2 SARS
measure: Number of symptomatic staff by occupational category and service
time frame: month 6
description: Number of symptomatic staff by occupational category and service at Month 6 with positive RT-PCR Cov2 SARS
measure: Number of contaminated personnel with effective protection
time frame: evolution at day 1, month 3 and month 6
description: Number of contaminated personnel with effective protection: evolution of the antibody index at day 1, month 3 and month 6
measure: comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies
time frame: month 6
description: comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies between two stitch dates.
arm group label: health workers at hospital
arm group type: Experimental
description: Three blood samples will be taken at day 1, month 3 and month 6. A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.
intervention type: Diagnostic Test
intervention name: Diagnostic test Covid-19
description: Three blood samples will be taken at day 1, month 3 and month 6 A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.
arm group label: health workers at hospital
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: PATOZ Pierre, PharmD
role: Principal Investigator
affiliation: CH Tourcoing
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No