<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/NCT04410432</url>
  </required_header>
  <id_info>
    <org_study_id>GHESQUIERE AOIc 2020</org_study_id>
    <nct_id>NCT04410432</nct_id>
  </id_info>
  <brief_title>Immune Response and Risk of Serious Infection to SARS-Cov2</brief_title>
  <official_title>Immune Response and Risk of Serious Infection to SARS-Cov2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To date, nearly 2 million people, including at least 100,000 in France, have been infected&#xD;
      with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very&#xD;
      heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress&#xD;
      syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%.&#xD;
&#xD;
      Apart from age, few risk factors for a pejorative evolution have been identified: arterial&#xD;
      hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in&#xD;
      particular. The median incubation period is 5 days and the median time between the appearance&#xD;
      of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to&#xD;
      12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are&#xD;
      unclear. One hypothesis is that it is related to an inappropriate inflammatory response&#xD;
      rather than a direct cytopathic effect of the virus. The objective of this study is to&#xD;
      measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS&#xD;
      infection in order to determine whether the intensity of the response is associated with&#xD;
      worsening of symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 29, 2020</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">August 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>Percentage of circulating Th1 lymphocytes</measure>
    <time_frame>Until the end of the study, about 12 months.</time_frame>
    <description>Flow cytometry measurement of the percentage of circulating Th1 lymphocytes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11</measure>
    <time_frame>Until the end of the study, about 12 months.</time_frame>
    <description>Immunofluorimetric measurement of serum concentrations of IFN-γ, CXCL9, CXCL10, CXCL11</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">63</enrollment>
  <condition>SARS Cov2, Immune Response</condition>
  <arm_group>
    <arm_group_label>Patient</arm_group_label>
    <description>Patient hospitalized with SARS-Cov2 infection proven by virological sampling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sample collection</intervention_name>
    <description>Additional blood volumes taken during a routine care blood test:&#xD;
1 dry tube 5 mL for isolation and freezing of serum&#xD;
1 x 5 mL EDTA tube to isolate and freeze plasma&#xD;
8 heparinized 6 mL tubes for flow cytometry study</description>
    <arm_group_label>Patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized for SARS-Cov-2 infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Person having given his or her non-opposition&#xD;
&#xD;
          -  Patient hospitalized with an SARS-Cov2 infection proven by virological sampling&#xD;
             (nasopharyngeal or sputum PCR) less than 8 days old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Person subject to a legal protection measure (curatorship, guardianship)&#xD;
&#xD;
          -  Person subject to a safeguard measure of justice&#xD;
&#xD;
          -  Pregnant, parturient or breastfeeding woman&#xD;
&#xD;
          -  Major incapable or incapable of giving consent&#xD;
&#xD;
          -  Minor&#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_contact>
    <last_name>Thibault GHESQUIERE</last_name>
    <phone>0380293857</phone>
    <phone_ext>+33</phone_ext>
    <email>thibault.squiere@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Dijon Bourogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thibault GHESQUIERE</last_name>
      <phone>0380293857</phone>
      <phone_ext>+33</phone_ext>
      <email>thibault.ghesquiere@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>January 15, 2021</last_update_submitted>
  <last_update_submitted_qc>January 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2021</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>
  </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/NCT04410432
org study id: GHESQUIERE AOIc 2020
nct id: NCT04410432
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To date, nearly 2 million people, including at least 100,000 in France, have been infected
      with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very
      heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress
      syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%.

      Apart from age, few risk factors for a pejorative evolution have been identified: arterial
      hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in
      particular. The median incubation period is 5 days and the median time between the appearance
      of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to
      12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are
      unclear. One hypothesis is that it is related to an inappropriate inflammatory response
      rather than a direct cytopathic effect of the virus. The objective of this study is to
      measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS
      infection in order to determine whether the intensity of the response is associated with
      worsening of symptoms.
observational model: Cohort
time perspective: Prospective
measure: Percentage of circulating Th1 lymphocytes
time frame: Until the end of the study, about 12 months.
description: Flow cytometry measurement of the percentage of circulating Th1 lymphocytes
measure: Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11
time frame: Until the end of the study, about 12 months.
description: Immunofluorimetric measurement of serum concentrations of IFN-γ, CXCL9, CXCL10, CXCL11
arm group label: Patient
description: Patient hospitalized with SARS-Cov2 infection proven by virological sampling.
intervention type: Biological
intervention name: Blood sample collection
description: Additional blood volumes taken during a routine care blood test:
1 dry tube 5 mL for isolation and freezing of serum
1 x 5 mL EDTA tube to isolate and freeze plasma
8 heparinized 6 mL tubes for flow cytometry study
arm group label: Patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thibault GHESQUIERE
phone: 0380293857
phone ext: +33
email: thibault.squiere@chu-dijon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Infections