<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/NCT04416308</url>
  </required_header>
  <id_info>
    <org_study_id>35RC20_9716</org_study_id>
    <nct_id>NCT04416308</nct_id>
  </id_info>
  <brief_title>COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne (AntiCoV-HB)</brief_title>
  <acronym>AntiCoV-HB</acronym>
  <official_title>COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fonds NOMINOE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      Since the start of this epidemic, numerous clinical and fundamental studies have been&#xD;
      conducted to best adapt the individual management of COVID-19 cases [1-6]. In parallel with&#xD;
      this work, it is necessary to better understand the characteristics of the epidemic in the&#xD;
      general population but also in the population working in healthcare settings more exposed to&#xD;
      SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand&#xD;
      the collective immunization rate and the factors that can explain this immunization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first cases of the new coronavirus disease 2019 (COVID-19) due to the SARS-CoV-2 virus&#xD;
      were reported in December 2019 in Wuhan, China. Since that date, a significant circulation of&#xD;
      the virus around the world has been observed, justifying that WHO described the situation as&#xD;
      pandemic on March 11.&#xD;
&#xD;
      Since the start of this epidemic, numerous clinical and fundamental studies have been&#xD;
      conducted to best adapt the individual management of COVID-19 cases. In parallel with this&#xD;
      work, it is necessary to better understand the characteristics of the epidemic in the general&#xD;
      population but also in the population working in healthcare settings more exposed to&#xD;
      SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand&#xD;
      the collective immunization rate and the factors that can explain this immunization. In the&#xD;
      general population, only one recent study in France, in the Oise, one of the first clusters&#xD;
      in France, reports a seroconversion rate of 35% in the area concerned [7]. This study used&#xD;
      three different tests (ELISA, S-FLOW, LIPS assays) to define seroconversion (people were&#xD;
      considered positive if at least one of the tests reported the presence of Anti SARS CoV 2&#xD;
      Antibodies).&#xD;
&#xD;
      The proportion of people infected in Brittany, estimated by modeling work, would be 1.8%&#xD;
      [1.1% -3.3%]. At the present time, no data exist to our knowledge on the seroprevalence of&#xD;
      anti SARS-CoV-2 antibodies in healthcare populations. Many serological tests are currently&#xD;
      being validated. The Rennes University Hospital, thanks to the support of the NOMINOE fund,&#xD;
      will offer all employees of the territory hospital group (GHT) Haute-Bretagne to participate&#xD;
      in this seroprevalence study using the serological test from the company NG-Biotech. It is a&#xD;
      device of the type &quot;rapid serological diagnostic orientation test (TROD)&quot; which can be&#xD;
      carried out outside medical biology laboratories by a doctor / pharmacist who is not a&#xD;
      biologist or a nurse. This test provides a result in about fifteen minutes. The NG-Biotech&#xD;
      test has a CE / IVD mark (pending opinion from the Institut Pasteur). An assessment of the&#xD;
      sensitivity and specificity of the test was carried out at the CHU Kremlin Bicêtre and CHU&#xD;
      Paul Brousse. From a sample of 101 COVID-19 patients (diagnosed by RT-PCR on nasopharyngeal&#xD;
      or pulmonary samples) and 50 negative controls (30 pre-pandemic sera from September and&#xD;
      October 2017 and 20 sera from patients tested COVID- 19 negative by RT-PCR without any&#xD;
      symptoms for more than 15 days) a sensitivity of 97% [88.7% - 99.4%] and a specificity of&#xD;
      100% [91.1% -100%] were obtained 15 days after the first signs of COVID-19 patients. If the&#xD;
      validity of the test is very good in this study, its main limitation is that it was carried&#xD;
      out with a group of COVID-19 patients who were in the vast majority hospitalized (84% of&#xD;
      patients) and therefore not representative of pauci or asymptomatic patients .&#xD;
&#xD;
      Consequently, given the absence of consolidated data on the immune response based on clinical&#xD;
      pictures, it is relevant to continue validation in a population of employees in which we wish&#xD;
      to carry out this seroprevalence study and where the majority of infections did not lead to&#xD;
      hospitalization. In addition, it is also necessary to obtain other data, in particular&#xD;
      concerning the inter-observer reproducibility of the test which has not yet been studied. The&#xD;
      need to validate the test in pauci or asymptomatic populations and to obtain reproducibility&#xD;
      data was underlined in the opinion of the HAS on the methods for evaluating the performance&#xD;
      of serological tests detecting antibodies directed against SARS-CoV -2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Actual">October 12, 2020</completion_date>
  <primary_completion_date type="Actual">July 10, 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>
    <intervention_model_description>This is a multi-center cross-sectional survey at risk and minimal constraints, among GHT Haute Bretagne employees in order to know the prevalence of the presence of anti-SARS-CoV-2 antibodies.&#xD;
For a sample of employees with no additional prospective follow-up will be done on D30 and D90.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>For the first 30 employees a second test will be carried out a few minutes after the first test by another nurse blinded to the result of the first test in order to estimate the agreement between - observers.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>rate of presence of anti-SARS-CoV-2 antibodies (Ig G _ Ig M) among employees working in a GHT Haute Bretagne health establishment.</measure>
    <time_frame>at inclusion visit</time_frame>
    <description>Rate of presence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>a) Validation of the Biotech NG test:</measure>
    <time_frame>at inclusion visit</time_frame>
    <description>Sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a) Validation of the Biotech NG test:</measure>
    <time_frame>at inclusion visit</time_frame>
    <description>Specificity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgG</measure>
    <time_frame>at inclusion visit</time_frame>
    <description>agreement between observers (kappa coefficient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgM.</measure>
    <time_frame>at inclusion visit</time_frame>
    <description>agreement between observers (kappa coefficient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>b) Risk of presence of anti SARS-CoV-2 antibodies in function:</measure>
    <time_frame>At inclusion visit</time_frame>
    <description>Demographic characteristics (age, sex)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>b) Risk of presence of anti SARS-CoV-2 antibodies in function:</measure>
    <time_frame>At inclusion visit</time_frame>
    <description>- Professional characteristics (establishment, profession, service).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>b) Risk of presence of anti SARS-CoV-2 antibodies in function:</measure>
    <time_frame>At inclusion visit</time_frame>
    <description>- Management of confirmed or probable COVID-19 patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>b) Risk of presence of anti SARS-CoV-2 antibodies in function:</measure>
    <time_frame>At inclusion visit</time_frame>
    <description>- From contact with confirmed or probable COVID-19 professionals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>b) Risk of presence of anti SARS-CoV-2 antibodies in function:</measure>
    <time_frame>At inclusion visit</time_frame>
    <description>- From contact in his personal circle with COVID-19 confirmed or probable persons.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>b) Risk of presence of anti SARS-CoV-2 antibodies in function:</measure>
    <time_frame>At inclusion visit</time_frame>
    <description>- Episodes of symptoms suggestive of COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>b) Risk of presence of anti SARS-CoV-2 antibodies in function:</measure>
    <time_frame>At inclusion visit</time_frame>
    <description>- The existence of a chronic immunomodulatory pathology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>b) Risk of presence of anti SARS-CoV-2 antibodies in function:</measure>
    <time_frame>At inclusion visit</time_frame>
    <description>- The existence of smoking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>c) Risk of presence of anti SARS-CoV-2 antibodies in function:</measure>
    <time_frame>At inclusion visit</time_frame>
    <description>- The use of materials adapted to good hygiene practices</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>c) Risk of presence of anti SARS-CoV-2 antibodies in function:</measure>
    <time_frame>At inclusion visit</time_frame>
    <description>- Service organization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>d) Description of the experience and behavioral changes related to the epidemic,</measure>
    <time_frame>at Day 0</time_frame>
    <description>depending on the work sector (COVID dedicated or not) and depending on the profession:&#xD;
- Rate of employees who changed their tobacco consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>d) Description of the experience and behavioral changes related to the epidemic,</measure>
    <time_frame>at Day 0</time_frame>
    <description>depending on the work sector (COVID dedicated or not) and depending on the profession:&#xD;
- Description of the reasons for modifying tobacco consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>d) Description of the experience and behavioral changes related to the epidemic,</measure>
    <time_frame>at Day 0</time_frame>
    <description>depending on the work sector (COVID dedicated or not) and depending on the profession:&#xD;
- Rate of employees who changed their alcohol consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>d) Description of the experience and behavioral changes related to the epidemic,</measure>
    <time_frame>at Day 0</time_frame>
    <description>depending on the work sector (COVID dedicated or not) and depending on the profession:&#xD;
- Description of the reasons for modification of alcohol consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>d) Description of the experience and behavioral changes related to the epidemic,</measure>
    <time_frame>at Day 0</time_frame>
    <description>depending on the work sector (COVID dedicated or not) and depending on the profession:&#xD;
- Rate of employees who have changed their eating habits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>d) Description of the experience and behavioral changes related to the epidemic,</measure>
    <time_frame>at Day 0</time_frame>
    <description>depending on the work sector (COVID dedicated or not) and depending on the profession:&#xD;
- Description of sleep changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>d) Description of the experience and behavioral changes related to the epidemic,</measure>
    <time_frame>at Day 0</time_frame>
    <description>depending on the work sector (COVID dedicated or not) and depending on the profession:&#xD;
- Description of lived experience and perceived stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>e) Evolution of seroprevalence over time:</measure>
    <time_frame>At Day30</time_frame>
    <description>For employees identified as COVID &quot;certain or probable&quot;&#xD;
* Percentage of employees with antibodies (IgG and IgM) against SARS CoV-2 on D30 and D90.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>e) Evolution of seroprevalence over time:</measure>
    <time_frame>At Day 90</time_frame>
    <description>For employees identified as COVID &quot;certain or probable&quot;&#xD;
* Evolution of the kinetics of antibodies (IgG and IgM) against SARS CoV-2 on D30 and D90.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>e) Evolution of seroprevalence over time:</measure>
    <time_frame>At Day 90</time_frame>
    <description>For the random sample of employees with follow-up on D90: Percentage of employees with antibodies (IgG and IgM) against SARS CoV-2</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">9453</enrollment>
  <condition>Coronavirus</condition>
  <arm_group>
    <arm_group_label>Seroprevalence survey</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>NG Test + short self-questionnaire (except validation survey and detailed survey)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Validation test of the NG test survey</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Blood test + NG test + detailed self-questionnaire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Detailed Survey</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>NG test + self-questionnaire complementary to the short questionnaire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prevalence monitoring (2 population samples)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants having presented a certain or probable COVID: acts of the validation test survey, + follow-up questionnaire,+ blood test + NG test, on D30 and D90&#xD;
Others Participants : drawn by lot: acts of the seroprevalence survey, + follow-up questionnaire + NG test, on D90</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>NG test</intervention_name>
    <description>rapid diagnosis Covid 19</description>
    <arm_group_label>Detailed Survey</arm_group_label>
    <arm_group_label>Prevalence monitoring (2 population samples)</arm_group_label>
    <arm_group_label>Seroprevalence survey</arm_group_label>
    <arm_group_label>Validation test of the NG test survey</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood test</intervention_name>
    <description>sample</description>
    <arm_group_label>Prevalence monitoring (2 population samples)</arm_group_label>
    <arm_group_label>Validation test of the NG test survey</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-questionnary</intervention_name>
    <description>behavioral survey</description>
    <arm_group_label>Detailed Survey</arm_group_label>
    <arm_group_label>Prevalence monitoring (2 population samples)</arm_group_label>
    <arm_group_label>Seroprevalence survey</arm_group_label>
    <arm_group_label>Validation test of the NG test survey</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Employees of voluntary establishments of GHT Haute-Bretagne&#xD;
&#xD;
          -  Employees over the age of 18&#xD;
&#xD;
          -  Having signed a free, informed and written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Employees subject to legal protection (safeguard of justice, guardianship,&#xD;
             curatorship)&#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>Christophe PARIS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Rennes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CENTRE HOSPITALIER de VITRE_ Saint Jean (La Guerche)</name>
      <address>
        <city>La Guerche de Bretagne</city>
        <state>La Guerche-de-Bretagne</state>
        <zip>35130</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Fougeres</name>
      <address>
        <city>Fougères</city>
        <zip>35300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Grand Fougeray</name>
      <address>
        <city>Grand-Fougeray</city>
        <zip>35390</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de La Roche Aux Fees</name>
      <address>
        <city>Janzé</city>
        <zip>35150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Montfort-Sur-Meu</name>
      <address>
        <city>Montfort sur Meu</city>
        <zip>35162</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Redon Carentoir</name>
      <address>
        <city>Redon</city>
        <zip>35603</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier St Meen Le Grand</name>
      <address>
        <city>Saint-Méen-le-Grand</city>
        <zip>35290</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CENTRE HOSPITALIER VITRE_Simone Veil</name>
      <address>
        <city>Vitré</city>
        <zip>35506</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Garlantezec R, Heslan C, Tadie E, Tattevin P, Thibault V, Paris C. A lateral flow immunoassay test performance in SARS-CoV-2 seroprevalence surveys: a validation study among healthcare workers. Emerg Microbes Infect. 2020 Dec;9(1):2547-2549. doi: 10.1080/22221751.2020.1852893.</citation>
    <PMID>33206004</PMID>
  </results_reference>
  <results_reference>
    <citation>Garlantezec R, Tadie E, Heslan C, Gary-Bobo P, Oumari S, Saade A, Sitruk A, Tattevin P, Thibault V, Paris C; AntiCOV-HB* working group. SARS-CoV-2 seroprevalence and antibodies persistence among health care workers after the first COVID-19 wave in nine hospitals in Western France. Infect Dis Now. 2022 Nov;52(8):447-452. doi: 10.1016/j.idnow.2022.09.004. Epub 2022 Sep 13.</citation>
    <PMID>36108975</PMID>
  </results_reference>
  <results_reference>
    <citation>Paris C, Tadie E, Heslan C, Gary-Bobo P, Oumari S, Saade A, Sitruk A, Wild P, Thibault V, Tattevin P, Garlantezec R. Risk factors for SARS-CoV-2 infection among health care workers. Am J Infect Control. 2022 Apr;50(4):375-382. doi: 10.1016/j.ajic.2021.11.001. Epub 2021 Nov 12.</citation>
    <PMID>34774895</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 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 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Covid 19, SRAS-CoV-2</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>Undecided</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/NCT04416308
org study id: 35RC20_9716
nct id: NCT04416308
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since the start of this epidemic, numerous clinical and fundamental studies have been
      conducted to best adapt the individual management of COVID-19 cases [1-6]. In parallel with
      this work, it is necessary to better understand the characteristics of the epidemic in the
      general population but also in the population working in healthcare settings more exposed to
      SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand
      the collective immunization rate and the factors that can explain this immunization.
The first cases of the new coronavirus disease 2019 (COVID-19) due to the SARS-CoV-2 virus
      were reported in December 2019 in Wuhan, China. Since that date, a significant circulation of
      the virus around the world has been observed, justifying that WHO described the situation as
      pandemic on March 11.

      Since the start of this epidemic, numerous clinical and fundamental studies have been
      conducted to best adapt the individual management of COVID-19 cases. In parallel with this
      work, it is necessary to better understand the characteristics of the epidemic in the general
      population but also in the population working in healthcare settings more exposed to
      SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand
      the collective immunization rate and the factors that can explain this immunization. In the
      general population, only one recent study in France, in the Oise, one of the first clusters
      in France, reports a seroconversion rate of 35% in the area concerned [7]. This study used
      three different tests (ELISA, S-FLOW, LIPS assays) to define seroconversion (people were
      considered positive if at least one of the tests reported the presence of Anti SARS CoV 2
      Antibodies).

      The proportion of people infected in Brittany, estimated by modeling work, would be 1.8%
      [1.1% -3.3%]. At the present time, no data exist to our knowledge on the seroprevalence of
      anti SARS-CoV-2 antibodies in healthcare populations. Many serological tests are currently
      being validated. The Rennes University Hospital, thanks to the support of the NOMINOE fund,
      will offer all employees of the territory hospital group (GHT) Haute-Bretagne to participate
      in this seroprevalence study using the serological test from the company NG-Biotech. It is a
      device of the type "rapid serological diagnostic orientation test (TROD)" which can be
      carried out outside medical biology laboratories by a doctor / pharmacist who is not a
      biologist or a nurse. This test provides a result in about fifteen minutes. The NG-Biotech
      test has a CE / IVD mark (pending opinion from the Institut Pasteur). An assessment of the
      sensitivity and specificity of the test was carried out at the CHU Kremlin Bicêtre and CHU
      Paul Brousse. From a sample of 101 COVID-19 patients (diagnosed by RT-PCR on nasopharyngeal
      or pulmonary samples) and 50 negative controls (30 pre-pandemic sera from September and
      October 2017 and 20 sera from patients tested COVID- 19 negative by RT-PCR without any
      symptoms for more than 15 days) a sensitivity of 97% [88.7% - 99.4%] and a specificity of
      100% [91.1% -100%] were obtained 15 days after the first signs of COVID-19 patients. If the
      validity of the test is very good in this study, its main limitation is that it was carried
      out with a group of COVID-19 patients who were in the vast majority hospitalized (84% of
      patients) and therefore not representative of pauci or asymptomatic patients .

      Consequently, given the absence of consolidated data on the immune response based on clinical
      pictures, it is relevant to continue validation in a population of employees in which we wish
      to carry out this seroprevalence study and where the majority of infections did not lead to
      hospitalization. In addition, it is also necessary to obtain other data, in particular
      concerning the inter-observer reproducibility of the test which has not yet been studied. The
      need to validate the test in pauci or asymptomatic populations and to obtain reproducibility
      data was underlined in the opinion of the HAS on the methods for evaluating the performance
      of serological tests detecting antibodies directed against SARS-CoV -2.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This is a multi-center cross-sectional survey at risk and minimal constraints, among GHT Haute Bretagne employees in order to know the prevalence of the presence of anti-SARS-CoV-2 antibodies.
For a sample of employees with no additional prospective follow-up will be done on D30 and D90.
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
masking description: For the first 30 employees a second test will be carried out a few minutes after the first test by another nurse blinded to the result of the first test in order to estimate the agreement between - observers.
measure: rate of presence of anti-SARS-CoV-2 antibodies (Ig G _ Ig M) among employees working in a GHT Haute Bretagne health establishment.
time frame: at inclusion visit
description: Rate of presence
measure: a) Validation of the Biotech NG test:
time frame: at inclusion visit
description: Sensitivity
measure: a) Validation of the Biotech NG test:
time frame: at inclusion visit
description: Specificity
measure: a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgG
time frame: at inclusion visit
description: agreement between observers (kappa coefficient)
measure: a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgM.
time frame: at inclusion visit
description: agreement between observers (kappa coefficient)
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
time frame: At inclusion visit
description: Demographic characteristics (age, sex)
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
time frame: At inclusion visit
description: - Professional characteristics (establishment, profession, service).
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
time frame: At inclusion visit
description: - Management of confirmed or probable COVID-19 patients
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
time frame: At inclusion visit
description: - From contact with confirmed or probable COVID-19 professionals.
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
time frame: At inclusion visit
description: - From contact in his personal circle with COVID-19 confirmed or probable persons.
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
time frame: At inclusion visit
description: - Episodes of symptoms suggestive of COVID-19
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
time frame: At inclusion visit
description: - The existence of a chronic immunomodulatory pathology
measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function:
time frame: At inclusion visit
description: - The existence of smoking
measure: c) Risk of presence of anti SARS-CoV-2 antibodies in function:
time frame: At inclusion visit
description: - The use of materials adapted to good hygiene practices
measure: c) Risk of presence of anti SARS-CoV-2 antibodies in function:
time frame: At inclusion visit
description: - Service organization
measure: d) Description of the experience and behavioral changes related to the epidemic,
time frame: at Day 0
description: depending on the work sector (COVID dedicated or not) and depending on the profession:
- Rate of employees who changed their tobacco consumption
measure: d) Description of the experience and behavioral changes related to the epidemic,
time frame: at Day 0
description: depending on the work sector (COVID dedicated or not) and depending on the profession:
- Description of the reasons for modifying tobacco consumption
measure: d) Description of the experience and behavioral changes related to the epidemic,
time frame: at Day 0
description: depending on the work sector (COVID dedicated or not) and depending on the profession:
- Rate of employees who changed their alcohol consumption
measure: d) Description of the experience and behavioral changes related to the epidemic,
time frame: at Day 0
description: depending on the work sector (COVID dedicated or not) and depending on the profession:
- Description of the reasons for modification of alcohol consumption
measure: d) Description of the experience and behavioral changes related to the epidemic,
time frame: at Day 0
description: depending on the work sector (COVID dedicated or not) and depending on the profession:
- Rate of employees who have changed their eating habits
measure: d) Description of the experience and behavioral changes related to the epidemic,
time frame: at Day 0
description: depending on the work sector (COVID dedicated or not) and depending on the profession:
- Description of sleep changes
measure: d) Description of the experience and behavioral changes related to the epidemic,
time frame: at Day 0
description: depending on the work sector (COVID dedicated or not) and depending on the profession:
- Description of lived experience and perceived stress
measure: e) Evolution of seroprevalence over time:
time frame: At Day30
description: For employees identified as COVID "certain or probable"
* Percentage of employees with antibodies (IgG and IgM) against SARS CoV-2 on D30 and D90.
measure: e) Evolution of seroprevalence over time:
time frame: At Day 90
description: For employees identified as COVID "certain or probable"
* Evolution of the kinetics of antibodies (IgG and IgM) against SARS CoV-2 on D30 and D90.
measure: e) Evolution of seroprevalence over time:
time frame: At Day 90
description: For the random sample of employees with follow-up on D90: Percentage of employees with antibodies (IgG and IgM) against SARS CoV-2
arm group label: Seroprevalence survey
arm group type: Other
description: NG Test + short self-questionnaire (except validation survey and detailed survey)
arm group label: Validation test of the NG test survey
arm group type: Other
description: Blood test + NG test + detailed self-questionnaire
arm group label: Detailed Survey
arm group type: Other
description: NG test + self-questionnaire complementary to the short questionnaire
arm group label: Prevalence monitoring (2 population samples)
arm group type: Other
description: Participants having presented a certain or probable COVID: acts of the validation test survey, + follow-up questionnaire,+ blood test + NG test, on D30 and D90
Others Participants : drawn by lot: acts of the seroprevalence survey, + follow-up questionnaire + NG test, on D90
intervention type: Diagnostic Test
intervention name: NG test
description: rapid diagnosis Covid 19
arm group label: Detailed Survey
arm group label: Prevalence monitoring (2 population samples)
arm group label: Seroprevalence survey
arm group label: Validation test of the NG test survey
intervention type: Diagnostic Test
intervention name: Blood test
description: sample
arm group label: Prevalence monitoring (2 population samples)
arm group label: Validation test of the NG test survey
intervention type: Behavioral
intervention name: Self-questionnary
description: behavioral survey
arm group label: Detailed Survey
arm group label: Prevalence monitoring (2 population samples)
arm group label: Seroprevalence survey
arm group label: Validation test of the NG test survey
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christophe PARIS, MD
role: Principal Investigator
affiliation: CHU Rennes
facility: 
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country: France
citation: Garlantezec R, Heslan C, Tadie E, Tattevin P, Thibault V, Paris C. A lateral flow immunoassay test performance in SARS-CoV-2 seroprevalence surveys: a validation study among healthcare workers. Emerg Microbes Infect. 2020 Dec;9(1):2547-2549. doi: 10.1080/22221751.2020.1852893.
PMID: 33206004
citation: Garlantezec R, Tadie E, Heslan C, Gary-Bobo P, Oumari S, Saade A, Sitruk A, Tattevin P, Thibault V, Paris C; AntiCOV-HB* working group. SARS-CoV-2 seroprevalence and antibodies persistence among health care workers after the first COVID-19 wave in nine hospitals in Western France. Infect Dis Now. 2022 Nov;52(8):447-452. doi: 10.1016/j.idnow.2022.09.004. Epub 2022 Sep 13.
PMID: 36108975
citation: Paris C, Tadie E, Heslan C, Gary-Bobo P, Oumari S, Saade A, Sitruk A, Wild P, Thibault V, Tattevin P, Garlantezec R. Risk factors for SARS-CoV-2 infection among health care workers. Am J Infect Control. 2022 Apr;50(4):375-382. doi: 10.1016/j.ajic.2021.11.001. Epub 2021 Nov 12.
PMID: 34774895
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided