<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/NCT04426006</url>
  </required_header>
  <id_info>
    <org_study_id>IB 2020-01</org_study_id>
    <secondary_id>2020-A01355-34</secondary_id>
    <nct_id>NCT04426006</nct_id>
  </id_info>
  <brief_title>Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic</brief_title>
  <acronym>PRO-SERO-COV</acronym>
  <official_title>Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic - PRO-SERO-COV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Bergonié</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Bergonié</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>
      The question of the immune response of the population, particularly of professional&#xD;
      populations in contact with vulnerable populations (such as those with chronic conditions&#xD;
      such as cancer), is an important issue. Knowing the evolution of this response over time in&#xD;
      this population can help answer outstanding questions. The PRO-SERO-COV study is a&#xD;
      seroprevalence study of caregivers working in the hospital sector with a follow-up at 3&#xD;
      months and 12 months. The objective is to evaluate and monitor at 3 and 12 months the&#xD;
      serological immune status to an infection by the SARS-CoV-2 virus in active volunteer&#xD;
      professionals working at the Institut Bergonié with different types of exposure: healthcare&#xD;
      professionals and professionals in other services.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Actual">January 1, 2022</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>Serological immune status to an infection by the SARS-CoV-2 virus</measure>
    <time_frame>Time 0 (Inclusion)</time_frame>
    <description>This will be determined from the detection of specific antibodies (immunoglobulins: IgM and IgG) or total antibodies carried out using the ELISA/ECLIA method allowing qualitative and semi-quantitative measures. These ELISA/ECLIA tests will be carried out in the medical biology laboratory of the Institut Bergonié.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serological immune status to an infection by the SARS-CoV-2 virus</measure>
    <time_frame>3 months, 12 months</time_frame>
    <description>This will be determined from the detection of specific antibodies (immunoglobulins: IgM and IgG) or total antibodies carried out using the ELISA/ECLIA method allowing qualitative and semi-quantitative measures. These ELISA/ECLIA tests will be carried out in the medical biology laboratory of the Institut Bergonié.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serological immune status to an infection by the SARS-CoV-2 virus</measure>
    <time_frame>Time 0 (inclusion), 3 months, 12 months</time_frame>
    <description>This will be determined from the detection of specific antibodies (immunoglobulins: IgA) carried out using the ELISA/ECLIA method allowing qualitative and semi-quantitative measures. These ELISA/ECLIA tests will be carried out in the medical biology laboratory of the Institut Bergonié.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The serological immune status to infection with the SARS-CoV-2 virus will also be determined from the different antibody isotypes (IgG and IgM), from a rapid diagnostic unit test (RDT).</measure>
    <time_frame>Time 0 (inclusion), 3 months, 12 months</time_frame>
    <description>Assessment using a &quot; rapid test on cassette &quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>kinetics of antibody production (IgG) against the SARS-CoV-2 virus</measure>
    <time_frame>Time 0 (inclusion), 3 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>kinetics of antibody production (IgM) against the SARS-CoV-2 virus</measure>
    <time_frame>Time 0 (inclusion), 3 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>kinetics of antibody production (IgA) against the SARS-CoV-2 virus</measure>
    <time_frame>Time 0 (inclusion), 3 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>active COVID-19 infection</measure>
    <time_frame>Time 0 (inclusion), 3 months, 12 months</time_frame>
    <description>Defined by a positive result for the molecular test for the detection of the SARS-CoV-2 coronavirus genome by RT-PCR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symptoms of anxiety</measure>
    <time_frame>Time 0 (inclusion), 3 months, 12 months</time_frame>
    <description>GAD-7 self-questionnaire (Spitzer et al. 2006), whose score varies from 0 to 21. The recommended threshold for estimating generalized anxiety is 10 points</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">550</enrollment>
  <condition>Sars-CoV2</condition>
  <condition>Serum; Disease</condition>
  <arm_group>
    <arm_group_label>PRO-SERO-COV</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Blood sample and self-administered questionnaire</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PRO-SERO-COV</intervention_name>
    <description>At inclusion, 3 months and 12 months :&#xD;
blood sample (2 x 5ml)&#xD;
self-administered questionnaire</description>
    <arm_group_label>PRO-SERO-COV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult 18 years-old and older.&#xD;
&#xD;
          2. Person in employment (on fixed-term or permanent contracts) since (at least) March&#xD;
             17th, 2020, the date of national implementation of containment measures in response to&#xD;
             the COVID-19 pandemic.&#xD;
&#xD;
          3. Signed informed consent.&#xD;
&#xD;
          4. Person affiliated to a French social security regimen in accordance with Article&#xD;
             1121-11 of the French Public Health Code).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Report of known active SARS-CoV-2 infection within 10 days prior to the date of&#xD;
             signing the consent. Known active SARS-CoV-2 infection is defined as a positive result&#xD;
             on a diagnostic RT-PCR test.&#xD;
&#xD;
          2. Presence of known symptoms suggestive of COVID-19 within 10 days prior to the date of&#xD;
             signing consent: fever, fatigue, dry cough, shortness of breath, loss of taste and/or&#xD;
             smell, headache, body aches, aches and pains, conjunctivitis or colds, digestive&#xD;
             disorders (vomiting, diarrhea).&#xD;
&#xD;
          3. A person who is unable to follow and comply with research procedures due to&#xD;
             geographical, social or psychological reasons.&#xD;
&#xD;
          4. Pregnant or breastfeeding woman.&#xD;
&#xD;
          5. Person deprived of their liberty, incapable or incapable of giving their consent.&#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>Simone MATHOULIN-PELISSIER, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>s.mathoulin@bordeaux.unicancer.fr</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Bergonié</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>February 2, 2022</last_update_submitted>
  <last_update_submitted_qc>February 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Health professionals</keyword>
  <keyword>Serology</keyword>
  <keyword>SARS-CoV-2 Antibodies</keyword>
  <keyword>Anxiety</keyword>
  <keyword>ELISA</keyword>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 25, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT04426006/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>June 24, 2022</submitted>
    <returned>April 11, 2023</returned>
    <submitted>April 13, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04426006
org study id: IB 2020-01
secondary id: 2020-A01355-34
nct id: NCT04426006
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The question of the immune response of the population, particularly of professional
      populations in contact with vulnerable populations (such as those with chronic conditions
      such as cancer), is an important issue. Knowing the evolution of this response over time in
      this population can help answer outstanding questions. The PRO-SERO-COV study is a
      seroprevalence study of caregivers working in the hospital sector with a follow-up at 3
      months and 12 months. The objective is to evaluate and monitor at 3 and 12 months the
      serological immune status to an infection by the SARS-CoV-2 virus in active volunteer
      professionals working at the Institut Bergonié with different types of exposure: healthcare
      professionals and professionals in other services.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Serological immune status to an infection by the SARS-CoV-2 virus
time frame: Time 0 (Inclusion)
description: This will be determined from the detection of specific antibodies (immunoglobulins: IgM and IgG) or total antibodies carried out using the ELISA/ECLIA method allowing qualitative and semi-quantitative measures. These ELISA/ECLIA tests will be carried out in the medical biology laboratory of the Institut Bergonié.
measure: Serological immune status to an infection by the SARS-CoV-2 virus
time frame: 3 months, 12 months
description: This will be determined from the detection of specific antibodies (immunoglobulins: IgM and IgG) or total antibodies carried out using the ELISA/ECLIA method allowing qualitative and semi-quantitative measures. These ELISA/ECLIA tests will be carried out in the medical biology laboratory of the Institut Bergonié.
measure: Serological immune status to an infection by the SARS-CoV-2 virus
time frame: Time 0 (inclusion), 3 months, 12 months
description: This will be determined from the detection of specific antibodies (immunoglobulins: IgA) carried out using the ELISA/ECLIA method allowing qualitative and semi-quantitative measures. These ELISA/ECLIA tests will be carried out in the medical biology laboratory of the Institut Bergonié.
measure: The serological immune status to infection with the SARS-CoV-2 virus will also be determined from the different antibody isotypes (IgG and IgM), from a rapid diagnostic unit test (RDT).
time frame: Time 0 (inclusion), 3 months, 12 months
description: Assessment using a " rapid test on cassette ".
measure: kinetics of antibody production (IgG) against the SARS-CoV-2 virus
time frame: Time 0 (inclusion), 3 months, 12 months
measure: kinetics of antibody production (IgM) against the SARS-CoV-2 virus
time frame: Time 0 (inclusion), 3 months, 12 months
measure: kinetics of antibody production (IgA) against the SARS-CoV-2 virus
time frame: Time 0 (inclusion), 3 months, 12 months
measure: active COVID-19 infection
time frame: Time 0 (inclusion), 3 months, 12 months
description: Defined by a positive result for the molecular test for the detection of the SARS-CoV-2 coronavirus genome by RT-PCR.
measure: symptoms of anxiety
time frame: Time 0 (inclusion), 3 months, 12 months
description: GAD-7 self-questionnaire (Spitzer et al. 2006), whose score varies from 0 to 21. The recommended threshold for estimating generalized anxiety is 10 points
arm group label: PRO-SERO-COV
arm group type: Other
description: Blood sample and self-administered questionnaire
intervention type: Other
intervention name: PRO-SERO-COV
description: At inclusion, 3 months and 12 months :
blood sample (2 x 5ml)
self-administered questionnaire
arm group label: PRO-SERO-COV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Simone MATHOULIN-PELISSIER, MD, PhD
role: Study Chair
affiliation: s.mathoulin@bordeaux.unicancer.fr
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
provided document: 
submitted: June 24, 2022
returned: April 11, 2023
submitted: April 13, 2023