<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/NCT04418206</url>
  </required_header>
  <id_info>
    <org_study_id>20-PP-10</org_study_id>
    <nct_id>NCT04418206</nct_id>
  </id_info>
  <brief_title>Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19</brief_title>
  <acronym>EliSpot</acronym>
  <official_title>Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19</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>
      The RT-PCR on rhino-pharynge sampling highlights the genetic material of the virus and&#xD;
      indicates that a subject is infected with SARS-CoV-2. This test can be in about 30% of false&#xD;
      negative cases, it does not allow to date the infection, nor to predict the asymptomatic,&#xD;
      mild, moderate or severe evolution of the disease. In terms of public health, we need 1/ to&#xD;
      better understand the chronology of the immune response to the virus in the general&#xD;
      population and in contacts of index cases; 2/ To know which characteristics of the immune&#xD;
      response are protective of future reinfections. Finally, in symptomatic subjects, we need&#xD;
      biomarkers that predict the evolutionary mode of the disease (moderate vs. severe form).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">July 19, 2022</completion_date>
  <primary_completion_date type="Actual">February 10, 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>
    <intervention_model_description>COVID-19 patients will be selected in the 4 participating centres Contact subjects and healthy volunteers will be selected only in the coordinating centre (Centre Hospitalier Universitaire de Nice)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IgA specific cells of SARS</measure>
    <time_frame>At 7 days</time_frame>
    <description>Proportion of subjects with IgA-specific cells of SARS-CoV-2's Spike 1 protein at inclusion and 7 +/-2 days later</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OMS progression scale</measure>
    <time_frame>At 7 days</time_frame>
    <description>The scale is 7-point ordinal.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">950</enrollment>
  <condition>Covid 19</condition>
  <arm_group>
    <arm_group_label>Samples With DNA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Nasopharyngal swab and blood samples</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>patients COVID 19</intervention_name>
    <description>Exposure to SARS-Cov2 but no symptoms (patient's family, medical staff) and General population (volunteers not exposed to SARS-Cov2)</description>
    <arm_group_label>Samples With DNA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 years,&#xD;
&#xD;
          -  patients with confirmed SARS-Cov2 infection (RT PCR positive)&#xD;
&#xD;
          -  or patients suspected (evocative chest scanner)&#xD;
&#xD;
          -  OR patients exposure to SARS-CoV2 but no symptoms (patient's family, caregivers)&#xD;
&#xD;
          -  OR patients Non exposure to SARS-Cov2 volunteer subjects (general population)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or breastfeeding female&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LEROY Sylvie</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Nice, pneumologie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CH Antibes</name>
      <address>
        <city>Antibes</city>
        <state>Alpes Maritimes</state>
        <zip>06606</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Cannes, Pneumologie</name>
      <address>
        <city>Cannes</city>
        <state>Alpes Maritimes</state>
        <zip>06414</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Grasse</name>
      <address>
        <city>Grasse</city>
        <state>Alpes Maritimes</state>
        <zip>06355</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de nice</name>
      <address>
        <city>Nice</city>
        <state>Alpes-Maritimes</state>
        <zip>06001</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</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>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/NCT04418206
org study id: 20-PP-10
nct id: NCT04418206
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The RT-PCR on rhino-pharynge sampling highlights the genetic material of the virus and
      indicates that a subject is infected with SARS-CoV-2. This test can be in about 30% of false
      negative cases, it does not allow to date the infection, nor to predict the asymptomatic,
      mild, moderate or severe evolution of the disease. In terms of public health, we need 1/ to
      better understand the chronology of the immune response to the virus in the general
      population and in contacts of index cases; 2/ To know which characteristics of the immune
      response are protective of future reinfections. Finally, in symptomatic subjects, we need
      biomarkers that predict the evolutionary mode of the disease (moderate vs. severe form).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: COVID-19 patients will be selected in the 4 participating centres Contact subjects and healthy volunteers will be selected only in the coordinating centre (Centre Hospitalier Universitaire de Nice)
primary purpose: Prevention
masking: None (Open Label)
measure: IgA specific cells of SARS
time frame: At 7 days
description: Proportion of subjects with IgA-specific cells of SARS-CoV-2's Spike 1 protein at inclusion and 7 +/-2 days later
measure: OMS progression scale
time frame: At 7 days
description: The scale is 7-point ordinal.
arm group label: Samples With DNA
arm group type: Other
description: Nasopharyngal swab and blood samples
intervention type: Other
intervention name: patients COVID 19
description: Exposure to SARS-Cov2 but no symptoms (patient's family, medical staff) and General population (volunteers not exposed to SARS-Cov2)
arm group label: Samples With DNA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: LEROY Sylvie
role: Principal Investigator
affiliation: CHU de Nice, pneumologie
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided