<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/NCT04429594</url>
  </required_header>
  <id_info>
    <org_study_id>20-PP-14</org_study_id>
    <nct_id>NCT04429594</nct_id>
  </id_info>
  <brief_title>Study of the Incidence of SARS-CoV-2 Infection (COVID-19)</brief_title>
  <acronym>CovImmune 2</acronym>
  <official_title>Study of the Incidence of SARS-CoV-2 Infection in the Alpes-Maritimes Department by Analysis of the Specific Humoral and Cellular Response During Deconfinement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</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>
      This is a prospective observational cohort study that will define the prevalence and&#xD;
      incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects&#xD;
      during deconfinement. The team wishes to include approximately 1000 subjects in this study.&#xD;
&#xD;
      The health crisis through containment has also created unprecedented environmental conditions&#xD;
      with the very clear decrease in economic activities and a consequent decrease in exposure to&#xD;
      the main air pollutants. The aim is therefore to carry out a case-control study in which each&#xD;
      subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then&#xD;
      exposed (after the recovery of economic activity and the usual levels of air pollutants) and&#xD;
      to measure the impact of these pollutants on the immune system and epigenetic markers taking&#xD;
      into account seasonality.&#xD;
&#xD;
      The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be&#xD;
      measured according to the immunological profiles measured at inclusion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2025</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>positive serologies</measure>
    <time_frame>12 months</time_frame>
    <description>number of positive serologies</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Coronavirus Infections</condition>
  <arm_group>
    <arm_group_label>volonteers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sampling</intervention_name>
    <description>blood sampling at J0, M6, M12, M24, M36, M48, M60</description>
    <arm_group_label>volonteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any major subject, voluntary, exposed to the public from 11 May 2020 informed of the&#xD;
             study by partner institutions (Departmental Council 06), affiliated to a social&#xD;
             security scheme,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject protected by law under tutorship or guardianship, or who cannot participate in&#xD;
             a clinical study under the terms of Article L. 1121-16 of the French Public Health&#xD;
             Code&#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_contact>
    <last_name>Barbara SEITZ, MCUPH</last_name>
    <phone>334 92 03 55 02</phone>
    <email>seitz-polski.b@chu-nice.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Nice Hospital</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara SEITZ- POLSKI</last_name>
      <phone>334.92.03.55.02</phone>
      <email>seitz-polski.b@chu-nice.fr</email>
    </contact>
    <investigator>
      <last_name>barbara SEITZ POLSKI</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>sonia BOYER SUAVET</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christian PRADIER</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</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>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <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/NCT04429594
org study id: 20-PP-14
nct id: NCT04429594
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective observational cohort study that will define the prevalence and
      incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects
      during deconfinement. The team wishes to include approximately 1000 subjects in this study.

      The health crisis through containment has also created unprecedented environmental conditions
      with the very clear decrease in economic activities and a consequent decrease in exposure to
      the main air pollutants. The aim is therefore to carry out a case-control study in which each
      subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then
      exposed (after the recovery of economic activity and the usual levels of air pollutants) and
      to measure the impact of these pollutants on the immune system and epigenetic markers taking
      into account seasonality.

      The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be
      measured according to the immunological profiles measured at inclusion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: positive serologies
time frame: 12 months
description: number of positive serologies
arm group label: volonteers
arm group type: Other
intervention type: Other
intervention name: blood sampling
description: blood sampling at J0, M6, M12, M24, M36, M48, M60
arm group label: volonteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Barbara SEITZ, MCUPH
phone: 334 92 03 55 02
email: seitz-polski.b@chu-nice.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Coronavirus Infections
mesh term: COVID-19
sharing ipd: No