<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/NCT04467008</url>
  </required_header>
  <id_info>
    <org_study_id>2020/05</org_study_id>
    <nct_id>NCT04467008</nct_id>
  </id_info>
  <brief_title>Covid-19 Rapid Diagnostic Tests on Blood Drop</brief_title>
  <acronym>COVID-TEST</acronym>
  <official_title>Evaluation of Covid-19 Rapid Diagnostic Tests on Blood Drop</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CMC Ambroise Paré</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CMC Ambroise Paré</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 study will evaluate the diagnostic reliability of the Biosynex rapid blood test for&#xD;
      Covid-19 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Covid-19 pandemic requires a reliable diagnosis of affected patients in order to manage&#xD;
      them in an appropriate manner, in the appropriate departments. Furthermore, the diagnostic&#xD;
      reference at the time of this study is based on reverse transcription by reaction in&#xD;
      polymerase chain reaction (RT-PCR) on a nasopharyngeal swab taken. This method has may yield&#xD;
      false negatives (up to 30% depending on the series) and its lead time is several hours.&#xD;
&#xD;
      Alternatives are therefore being developed, in particular rapid blood tests. The rapid&#xD;
      diagnostic test distributed by Biosynex has been evaluated by the National Reference Center&#xD;
      for Respiratory Infections Viruses as very specific for the detection of IgG + IgM (93%).&#xD;
&#xD;
      As part of the evaluation of this test, it was used in patients with severe Covid-19 disease,&#xD;
      requiring hospitalization in critical care in order to be able to establish their reliability&#xD;
      in a clinical context where many confounding factors may occur, such as lymphopenia or&#xD;
      systemic inflammation. However, the early diagnosis of this patient population remains&#xD;
      critical in order to be able to refer them to the appropriate services.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">August 15, 2020</completion_date>
  <primary_completion_date type="Actual">August 15, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Positivity of the rapid diagnostic test</measure>
    <time_frame>Immediate, up to 1 day.</time_frame>
    <description>Positivity of the rapid diagnostic test, assessed by the presence of either IgM or IgG</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">113</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>One group of patients</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with confirmed COVID-19 pneumonia (using RT-PCR) who required hospitalization in&#xD;
        intensive care unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed COVID-19 diagnosis with at least one positive RT-PCR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lee Nguyen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CMC Ambroise Paré</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CMC Ambroise Paré</name>
      <address>
        <city>Neuilly-sur-Seine</city>
        <zip>92200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Covid 19</keyword>
  <keyword>Diagnostic</keyword>
  <keyword>Biosynex</keyword>
  <keyword>Blood drop</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04467008
org study id: 2020/05
nct id: NCT04467008
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for
      Covid-19 infection.
The Covid-19 pandemic requires a reliable diagnosis of affected patients in order to manage
      them in an appropriate manner, in the appropriate departments. Furthermore, the diagnostic
      reference at the time of this study is based on reverse transcription by reaction in
      polymerase chain reaction (RT-PCR) on a nasopharyngeal swab taken. This method has may yield
      false negatives (up to 30% depending on the series) and its lead time is several hours.

      Alternatives are therefore being developed, in particular rapid blood tests. The rapid
      diagnostic test distributed by Biosynex has been evaluated by the National Reference Center
      for Respiratory Infections Viruses as very specific for the detection of IgG + IgM (93%).

      As part of the evaluation of this test, it was used in patients with severe Covid-19 disease,
      requiring hospitalization in critical care in order to be able to establish their reliability
      in a clinical context where many confounding factors may occur, such as lymphopenia or
      systemic inflammation. However, the early diagnosis of this patient population remains
      critical in order to be able to refer them to the appropriate services.
observational model: Cohort
time perspective: Retrospective
measure: Positivity of the rapid diagnostic test
time frame: Immediate, up to 1 day.
description: Positivity of the rapid diagnostic test, assessed by the presence of either IgM or IgG
arm group label: One group of patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Lee Nguyen, MD
role: Principal Investigator
affiliation: CMC Ambroise Paré
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19