<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/NCT04404270</url>
  </required_header>
  <id_info>
    <org_study_id>2020-COVID19-22</org_study_id>
    <secondary_id>2020-A01368-31</secondary_id>
    <nct_id>NCT04404270</nct_id>
  </id_info>
  <brief_title>Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)</brief_title>
  <acronym>EpiCovCreil</acronym>
  <official_title>Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Direction Centrale du Service de Santé des Armées</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Direction Centrale du Service de Santé des Armées</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>
      In mid-February 2020, within the Oise (France) cluster, a case of COVID-19 disease caused by&#xD;
      a SARS-CoV2 infection was described among the personnel of the Creail Air Force Base (BA110).&#xD;
      This resulted in the beginning of an epidemic controlled by epidemiological measures. One&#xD;
      month later, containment measures were taken at the national level, measures that also&#xD;
      applied to BA110 personnel. These personnel, exposed to both the initial phase of the&#xD;
      epidemic and national protection measures, represent an extremely interesting population for&#xD;
      understanding the epidemiological dynamics of the virus, particularly at a time when France&#xD;
      is lifting the containment measures. It becomes extremely important to understand the levers&#xD;
      of viral spread in order to adjust the health measures to be maintained as best as possible.&#xD;
&#xD;
      The main objective of this study is to determine the extent of virus diffusion in this highly&#xD;
      circulating population, as evidenced by several identified cases of COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Actual">March 13, 2021</completion_date>
  <primary_completion_date type="Actual">March 13, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion anti-SARS-CoV2 seropositive</measure>
    <time_frame>Day 0</time_frame>
    <description>The percentage of the study population with positive serological status will be determined. ELISA serology test will be used to detect anti-SARS-CoV2 antibodies (IgG and IgM) at Day 0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of asymptomatic anti-SARS-CoV2 seropositive participants</measure>
    <time_frame>Day 0</time_frame>
    <description>Among anti-SARS-CoV2 seropositive participants, the percentage of asymptomatic participants will be determined. COVID-19 symptoms will be measured using a questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Agreement between the anti-SARS-CoV2 serological results obtained using two different techniques (detecting the presence of different antibodies)</measure>
    <time_frame>Day 0</time_frame>
    <description>The serological results obtained using the reference ELISA test results (detecting the presence of IgG and IgM antobodies) and using a second ELISA test detecting the presence of antibodies specifically directed against the Receptor Binding Domain and the Spike protein trimer of SARS-CoV2 virus will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of serum neutralization positive</measure>
    <time_frame>Day 0</time_frame>
    <description>Among anti-SARS-CoV2 seropositive participants, the percentage of participants with a positive response to serum neutralization will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of antibody level over time</measure>
    <time_frame>3 months and 9 months after Day 0</time_frame>
    <description>The evolution of the antibody level over time will be determined using repeated serodiagnoses at 3 and 9 months.</description>
  </secondary_outcome>
  <enrollment type="Actual">1146</enrollment>
  <condition>Sars-CoV2</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Anti-SARS-CoV2 Serology</intervention_name>
    <description>The anti-SARS-CoV2 serological status will be measured on a blood sample collected at Day 0.</description>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Epidemiological data will be collected in a questionnaire that will be filled by participants at Day 0 (Visit 1), after 3 months (Visit 2) and after 9 months (Visit 3).&#xD;
The questionnaire includes:&#xD;
medical data (height, weight, smoking, history of intense stress);&#xD;
socio-demographic data (age, gender, civil/military status, function/occupation, rank category, army, family status/home composition, housing conditions, etc.);&#xD;
clinical data : history of symptoms suggestive of COVID-19 in the last 3 months, current symptoms suggestive of COVID-19;&#xD;
use of care, hospitalization, work stoppage in the last 3 months;&#xD;
contact with people who are symptomatic or proven COVID-19.</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Anti-SARS-CoV2 serological controls and serum neutralization</intervention_name>
    <description>Serological controls and a serum neutralization test will be performed on blood samples collected 3 months (Visit 2) and 9 months (Visit 3) after Day 0, respectively.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The eligible population is composed of all civilian and military personnel working on the&#xD;
        Creil Air Force Base (BA110) or having worked on BA110 as a permanent personnel since&#xD;
        February 1st 2020, including the people working in satellite units such as the &quot;Groupement&#xD;
        de soutien de base de Défense&quot; de Creil (&quot;Creil Defence Base Support Group&quot;) or the 3/60&#xD;
        Esterel squadron.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active military or civilian defence personnel working on the Creil Air Force Base&#xD;
             (BA110) during the period of interest (from February 1st 2020 to the end of the study)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to blood sampling&#xD;
&#xD;
          -  Pregnant, parturient, breastfeeding woman&#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>
  <location>
    <facility>
      <name>24e antenne médicale de Creil</name>
      <address>
        <city>Creil</city>
        <zip>60314</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 6, 2021</last_update_submitted>
  <last_update_submitted_qc>July 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2021</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/NCT04404270
org study id: 2020-COVID19-22
secondary id: 2020-A01368-31
nct id: NCT04404270
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In mid-February 2020, within the Oise (France) cluster, a case of COVID-19 disease caused by
      a SARS-CoV2 infection was described among the personnel of the Creail Air Force Base (BA110).
      This resulted in the beginning of an epidemic controlled by epidemiological measures. One
      month later, containment measures were taken at the national level, measures that also
      applied to BA110 personnel. These personnel, exposed to both the initial phase of the
      epidemic and national protection measures, represent an extremely interesting population for
      understanding the epidemiological dynamics of the virus, particularly at a time when France
      is lifting the containment measures. It becomes extremely important to understand the levers
      of viral spread in order to adjust the health measures to be maintained as best as possible.

      The main objective of this study is to determine the extent of virus diffusion in this highly
      circulating population, as evidenced by several identified cases of COVID-19.
observational model: Cohort
time perspective: Prospective
measure: Proportion anti-SARS-CoV2 seropositive
time frame: Day 0
description: The percentage of the study population with positive serological status will be determined. ELISA serology test will be used to detect anti-SARS-CoV2 antibodies (IgG and IgM) at Day 0
measure: Proportion of asymptomatic anti-SARS-CoV2 seropositive participants
time frame: Day 0
description: Among anti-SARS-CoV2 seropositive participants, the percentage of asymptomatic participants will be determined. COVID-19 symptoms will be measured using a questionnaire.
measure: Agreement between the anti-SARS-CoV2 serological results obtained using two different techniques (detecting the presence of different antibodies)
time frame: Day 0
description: The serological results obtained using the reference ELISA test results (detecting the presence of IgG and IgM antobodies) and using a second ELISA test detecting the presence of antibodies specifically directed against the Receptor Binding Domain and the Spike protein trimer of SARS-CoV2 virus will be compared.
measure: Proportion of serum neutralization positive
time frame: Day 0
description: Among anti-SARS-CoV2 seropositive participants, the percentage of participants with a positive response to serum neutralization will be determined.
measure: Change of antibody level over time
time frame: 3 months and 9 months after Day 0
description: The evolution of the antibody level over time will be determined using repeated serodiagnoses at 3 and 9 months.
intervention type: Diagnostic Test
intervention name: Anti-SARS-CoV2 Serology
description: The anti-SARS-CoV2 serological status will be measured on a blood sample collected at Day 0.
intervention type: Behavioral
intervention name: Questionnaire
description: Epidemiological data will be collected in a questionnaire that will be filled by participants at Day 0 (Visit 1), after 3 months (Visit 2) and after 9 months (Visit 3).
The questionnaire includes:
medical data (height, weight, smoking, history of intense stress);
socio-demographic data (age, gender, civil/military status, function/occupation, rank category, army, family status/home composition, housing conditions, etc.);
clinical data : history of symptoms suggestive of COVID-19 in the last 3 months, current symptoms suggestive of COVID-19;
use of care, hospitalization, work stoppage in the last 3 months;
contact with people who are symptomatic or proven COVID-19.
intervention type: Diagnostic Test
intervention name: Anti-SARS-CoV2 serological controls and serum neutralization
description: Serological controls and a serum neutralization test will be performed on blood samples collected 3 months (Visit 2) and 9 months (Visit 3) after Day 0, respectively.
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor