<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/NCT04490850</url>
  </required_header>
  <id_info>
    <org_study_id>2020-048</org_study_id>
    <nct_id>NCT04490850</nct_id>
  </id_info>
  <brief_title>COVID-19 Seroprevalence Study in French Guiana</brief_title>
  <acronym>EPI-COVID-POP</acronym>
  <official_title>COVID-19 Seroprevalence Study in French Guiana</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Pasteur</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut Pasteur de la Guyane</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laboratoire de biologie médicale, Institut Pasteur de la Guyane</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laboratoire de biologie médicale de Kourou, French Guiana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laboratoire de biologie médicale du Centre hospitalier de Saint-Laurent du Maroni, French Guiana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eurofins</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centres Délocalisés de Prévention et de Soins, Centre Hospitalier Andrée Rosemon de Cayenne, Frech Guiana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut Pasteur</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>
      Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2&#xD;
      (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the&#xD;
      COVID-19 immunity of the population in French Guiana.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2&#xD;
      (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the&#xD;
      COVID-19 immunity of the population in French Guiana.&#xD;
&#xD;
      This study is a interventional study that present minimal risks and constraints.&#xD;
&#xD;
      The results of the study will allow estimation of COVID-19 virus infection, severity and&#xD;
      attack rates, as well as inform public health responses and policy decisions in the French&#xD;
      Guiana territory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">September 24, 2021</completion_date>
  <primary_completion_date type="Actual">September 24, 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>Measure of the COVID-19 immunity of the population</measure>
    <time_frame>1 year</time_frame>
    <description>The COVID-19 immunity of the population will be assessed by evaluating the anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the level of asymptomatic and pauci-symptomatic infections</measure>
    <time_frame>1 year</time_frame>
    <description>The proportion of asymptomatic and pauci-symptomatic infections will be measured in the population</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3541</enrollment>
  <condition>Coronavirus Infection</condition>
  <condition>Severe Acute Respiratory Syndrome</condition>
  <condition>SARS-CoV Infection</condition>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood sample</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>Blood sample</description>
    <arm_group_label>Participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Person going to a prevention and care center or medical biology analysis laboratory as&#xD;
             part of the care, regardless age, regardless of an acute or previous infection with&#xD;
             COVID-19;&#xD;
&#xD;
          -  State of health compatible with a blood sample as defined in the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to consent&#xD;
&#xD;
          -  Person under guardianship or curatorship&#xD;
&#xD;
          -  Known pathology or a health problem contraindicated with the collect of blood sample.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claude Flamand, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Pasteur de la Guyane, Head of Epidemiology Unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Andrée Rosemon</name>
      <address>
        <city>Cayenne</city>
        <country>French Guiana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laboratoire de biologie méicale, Institut Pasteur de la Guyane</name>
      <address>
        <city>Cayenne</city>
        <country>French Guiana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laboratoires Eurofins Guyane</name>
      <address>
        <city>Cayenne</city>
        <country>French Guiana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laboratoire de biologie médicale de Kourou</name>
      <address>
        <city>Kourou</city>
        <country>French Guiana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laboratoire de biologie médicale du Centre hospitalier de Saint-Laurent du Maroni</name>
      <address>
        <city>Saint-Laurent du Maroni</city>
        <country>French Guiana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>French Guiana</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Serology</keyword>
  <keyword>French Guiana</keyword>
  <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>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT04490850
org study id: 2020-048
nct id: NCT04490850
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2
      (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the
      COVID-19 immunity of the population in French Guiana.
Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2
      (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the
      COVID-19 immunity of the population in French Guiana.

      This study is a interventional study that present minimal risks and constraints.

      The results of the study will allow estimation of COVID-19 virus infection, severity and
      attack rates, as well as inform public health responses and policy decisions in the French
      Guiana territory.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Measure of the COVID-19 immunity of the population
time frame: 1 year
description: The COVID-19 immunity of the population will be assessed by evaluating the anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies
measure: Evaluation of the level of asymptomatic and pauci-symptomatic infections
time frame: 1 year
description: The proportion of asymptomatic and pauci-symptomatic infections will be measured in the population
arm group label: Participants
arm group type: Experimental
description: Blood sample
intervention type: Procedure
intervention name: Blood sample
description: Blood sample
arm group label: Participants
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Claude Flamand, PhD
role: Principal Investigator
affiliation: Institut Pasteur de la Guyane, Head of Epidemiology Unit
facility: 
facility: 
facility: 
facility: 
facility: 
country: French Guiana
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Severe Acute Respiratory Syndrome