<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/NCT04427254</url>
  </required_header>
  <id_info>
    <org_study_id>PBN_2020_16</org_study_id>
    <nct_id>NCT04427254</nct_id>
  </id_info>
  <brief_title>Study of the Sars-Cov2 Neuroinvasiveness - COVID19</brief_title>
  <acronym>CORONEVRAXE</acronym>
  <official_title>Study of the Sars-Cov2 Neuroinvasiveness - COVID19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</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>
      Sars-Cov2 (COVID-19) may invade the CNS inducing neurological diseases such as anosmia,&#xD;
      ageusia, encephalitis, ischemic or hemorrhagic stroke. Management of severe neurological&#xD;
      complications in COVID-19 patients may require ventricular cerebrospinal fluid drainage and&#xD;
      cranial decompression. During surgery, cerebrospinal fluid, meninges and brain parenchyma can&#xD;
      be safely removed from the patient. In this study, COVID-19 patients will be evaluated first,&#xD;
      for the presence of Sars-Cov2 in the cerebrospinal fluid and/or biopsies and second, for the&#xD;
      consequences of Sars-Cov2 neuroinfection in terms of inflammatory and immune responses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    enrollment number not reached&#xD;
  </why_stopped>
  <start_date type="Actual">June 26, 2020</start_date>
  <completion_date type="Actual">November 25, 2022</completion_date>
  <primary_completion_date type="Actual">November 25, 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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with COVID-19 positive samples/biopsies</measure>
    <time_frame>At the time of the inclusion</time_frame>
    <description>COVID-19 RT-PCR test</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>COVID19</condition>
  <arm_group>
    <arm_group_label>Neurological biological samples</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies</intervention_name>
    <description>Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies</description>
    <arm_group_label>Neurological biological samples</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COVID-19 patients requiring an external ventricular drain, a decompressive craniectomy&#xD;
             or an intracranial hematoma surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#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>Pierre BOURDILLON, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation A. de Rothschild</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondation A de Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sars-Cov2 neuroinvasiveness</keyword>
  <keyword>COVID-19 RT-PCR test</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/NCT04427254
org study id: PBN_2020_16
nct id: NCT04427254
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Sars-Cov2 (COVID-19) may invade the CNS inducing neurological diseases such as anosmia,
      ageusia, encephalitis, ischemic or hemorrhagic stroke. Management of severe neurological
      complications in COVID-19 patients may require ventricular cerebrospinal fluid drainage and
      cranial decompression. During surgery, cerebrospinal fluid, meninges and brain parenchyma can
      be safely removed from the patient. In this study, COVID-19 patients will be evaluated first,
      for the presence of Sars-Cov2 in the cerebrospinal fluid and/or biopsies and second, for the
      consequences of Sars-Cov2 neuroinfection in terms of inflammatory and immune responses.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Percentage of patients with COVID-19 positive samples/biopsies
time frame: At the time of the inclusion
description: COVID-19 RT-PCR test
arm group label: Neurological biological samples
arm group type: Experimental
intervention type: Drug
intervention name: Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies
description: Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies
arm group label: Neurological biological samples
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre BOURDILLON, MD
role: Principal Investigator
affiliation: Fondation A. de Rothschild
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19