<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/NCT04408391</url>
  </required_header>
  <id_info>
    <org_study_id>NIMAO/2020-01/BL-001</org_study_id>
    <nct_id>NCT04408391</nct_id>
  </id_info>
  <brief_title>Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia</brief_title>
  <acronym>ANOSIRM</acronym>
  <official_title>Descriptive Pilot Study of Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</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 there is no brain imaging and olfactory data available in COVID-19 positive patients&#xD;
      with anosmia. By describing the pathophysiological characteristics underlying the olfactory&#xD;
      symptoms and clinical characteristics of COVID-19 infection, the study investigators wish to&#xD;
      compare the MRI aspects obtained in COVID-19 patients with and without anosmia, in the&#xD;
      absence of other underlying neurological disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Brain mapping of COVID-19 patients with or without anosmia will allow better understanding of&#xD;
      the mechanisms leading to the onset of these symptoms and will provide a pathophysiological&#xD;
      basis for the therapeutic interventions to improve the clinical prognosis of affected&#xD;
      patients.&#xD;
&#xD;
      The study investigators hypothesize that in COVID-19 patients witch anosmia the brain mapping&#xD;
      objectified by an MRI examination is modified and that there are functional abnormalities in&#xD;
      the brain in these patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No Inclusion potentiel&#xD;
  </why_stopped>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">July 6, 2020</completion_date>
  <primary_completion_date type="Actual">July 6, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Brain regional homogeneity between COVID-19 patients with and without anosmia</measure>
    <time_frame>Day 0</time_frame>
    <description>MRI; Voxels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain regional homogeneity between COVID-19 patients with and without anosmia</measure>
    <time_frame>Month 3</time_frame>
    <description>MRI; Voxels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Topography of supra- or sub-tentorial lesions between COVID-19 patients with and without anosmia</measure>
    <time_frame>Day 0</time_frame>
    <description>MRI; Voxels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fractional anisotropy between COVID-19 patients with and without anosmia</measure>
    <time_frame>Day 0</time_frame>
    <description>MRI; voxels, value between 0-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fractional anisotropy between COVID-19 patients with and without anosmia</measure>
    <time_frame>Month 3</time_frame>
    <description>MRI; voxels, value between 0-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean diffusivity between COVID-19 patients with and without anosmia</measure>
    <time_frame>Day 0</time_frame>
    <description>MRI; mm2/s</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean diffusivity between COVID-19 patients with and without anosmia</measure>
    <time_frame>Month 3</time_frame>
    <description>MRI; mm2/s</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radial diffusivity between COVID-19 patients with and without anosmia</measure>
    <time_frame>Day 0</time_frame>
    <description>MRI; mm2/s</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radial diffusivity between COVID-19 patients with and without anosmia</measure>
    <time_frame>Month 3</time_frame>
    <description>MRI; mm2/s</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-assessed olfactory and gustatory test</measure>
    <time_frame>Day 0</time_frame>
    <description>Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-assessed olfactory and gustatory test</measure>
    <time_frame>Day 8</time_frame>
    <description>Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-assessed olfactory and gustatory test</measure>
    <time_frame>Month 1</time_frame>
    <description>Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-assessed olfactory and gustatory test</measure>
    <time_frame>Month 2</time_frame>
    <description>Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to detect odor</measure>
    <time_frame>Day 0</time_frame>
    <description>Ability to smell 1.5ml air freshner on a 0-100 VAS scale (cut-offs: strang (&gt;80), moderate (40-80), attenuated (&lt;40)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to taste a pinch of sugar</measure>
    <time_frame>Day 0</time_frame>
    <description>Patient asked to describe whether a pinch of sugar on their tongue taste sweet or salty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of thrombotic and hemorrhagic lesions</measure>
    <time_frame>Day 0</time_frame>
    <description>MRI: absence/presence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of thrombotic and hemorrhagic lesions</measure>
    <time_frame>Month 3</time_frame>
    <description>MRI: absence/presence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of lesions with hyperintensity</measure>
    <time_frame>Day 0</time_frame>
    <description>Short Ti Inversion Recovery (STIR); presence/absence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of lesions with hyperintensity</measure>
    <time_frame>Month 3</time_frame>
    <description>Short Ti Inversion Recovery (STIR); presence/absence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Projection network analysis of all patients</measure>
    <time_frame>Day 0</time_frame>
    <description>beta voxels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Projection network analysis of all patients</measure>
    <time_frame>Month 3</time_frame>
    <description>beta voxels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blinded independent component analysis of all patients</measure>
    <time_frame>Day 0</time_frame>
    <description>beta voxels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blinded independent component analysis of all patients</measure>
    <time_frame>Month 3</time_frame>
    <description>beta voxels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>default mode network analysis of all patients</measure>
    <time_frame>Day 0</time_frame>
    <description>beta voxels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>default mode network analysis of all patients</measure>
    <time_frame>Month 3</time_frame>
    <description>beta voxels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>executive control network analysis of all patients</measure>
    <time_frame>Day 0</time_frame>
    <description>beta voxels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>executive control network analysis of all patients</measure>
    <time_frame>Month 3</time_frame>
    <description>beta voxels</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Covid-19</condition>
  <condition>Anosmia</condition>
  <arm_group>
    <arm_group_label>COVID-19 patients with anosmia</arm_group_label>
    <description>Patients reporting loss of smell and scoring &lt; 30 on a VAS 0-100 for ability to detect n-Butanol diluted 1/1000</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID-19 patients without anosmia</arm_group_label>
    <description>Patients reporting no loss of smell and scoring &gt; 80 on a VAS 0-100 for ability to detect n-Butanol diluted 1/16000</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brain MRI scan</intervention_name>
    <description>Resting state, functional, structural and morphometric MRI; diffusion tensor imaging on a 3-Tesla MRI scanner</description>
    <arm_group_label>COVID-19 patients with anosmia</arm_group_label>
    <arm_group_label>COVID-19 patients without anosmia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive adult patients consulting the CAREB or hospitalized at the Nîmes teaching&#xD;
        hospital due to COVID-19 infection confirmed by RT-PCR and / or chest CT or clinical&#xD;
        characteristics (i.e an epidemic history and 2 clinical manifestations or at least 3&#xD;
        clinical manifestations) with or without anosmia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive adult patients consulting the CAREB or hospitalized at the Nîmes teaching&#xD;
             hospital due to COVID-19 infection (fever, persistent cough, tiredness, shortness of&#xD;
             breath, diarrhea, abdominal pain, chest pain, sore throat, loss of smell or taste)&#xD;
&#xD;
          -  COVID-19 confirmed by RT-PCR and / or chest CT or clinical characteristics (i.e an&#xD;
             epidemic history and 2 clinical manifestations or at least 3 clinical manifestations)&#xD;
&#xD;
          -  The patient must have given their free and informed consent and signed the consent&#xD;
             form&#xD;
&#xD;
          -  The patient must be a member or beneficiary of a health insurance plan &quot;with anosmia&quot;&#xD;
             group:&#xD;
&#xD;
          -  scoring &lt; 30 on a VAS 0-100 for olfactory ability&#xD;
&#xD;
          -  Responding &quot;yes&quot; to question &quot;have you lost your sense of smell in the last few days?&quot;&#xD;
&#xD;
          -  Negative result to olfactory test with n-Butanol diluted to 1/1000. &quot;without anosmia&quot;&#xD;
             group:&#xD;
&#xD;
          -  scoring &lt; 80 on a VAS 0-100 for olfactory ability&#xD;
&#xD;
          -  Responding &quot;no&quot; to question &quot;have you lost your sense of smell in the last few days?&quot;&#xD;
&#xD;
          -  Positive result to olfactory test with n-Butanol diluted to 1/16000.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient suffering from serious medical problems or hospitalized in an intensive care&#xD;
             unit for invasive ventilation or severe dyspnea.&#xD;
&#xD;
          -  Patient with neurological (motor, sensitive or cognitive), neuropsychiatric or&#xD;
             vascular disorders.&#xD;
&#xD;
          -  Patient with a contraindication to MRI (pace maker, claustrophobic patient, metallic&#xD;
             heart valve, etc.).&#xD;
&#xD;
          -  Patient with a history of rhinological pathology or a sense of smell problem.&#xD;
&#xD;
          -  Patient with known neurological, psychiatric or neuroradiological manifestation.The&#xD;
             subject is participating in a category 1 interventional study, or is in a period of&#xD;
             exclusion determined by a previous study&#xD;
&#xD;
          -  The subject is unable to express consent&#xD;
&#xD;
          -  It is impossible to give the subject informed information&#xD;
&#xD;
          -  The patient is under safeguard of justice or state guardianship&#xD;
&#xD;
          -  Patient is pregnant, parturient or breastfeeding&#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>Benjamin Lallemant</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Nimes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Nimes</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</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>
    <mesh_term>Anosmia</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/NCT04408391
org study id: NIMAO/2020-01/BL-001
nct id: NCT04408391
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To date there is no brain imaging and olfactory data available in COVID-19 positive patients
      with anosmia. By describing the pathophysiological characteristics underlying the olfactory
      symptoms and clinical characteristics of COVID-19 infection, the study investigators wish to
      compare the MRI aspects obtained in COVID-19 patients with and without anosmia, in the
      absence of other underlying neurological disorders.
Brain mapping of COVID-19 patients with or without anosmia will allow better understanding of
      the mechanisms leading to the onset of these symptoms and will provide a pathophysiological
      basis for the therapeutic interventions to improve the clinical prognosis of affected
      patients.

      The study investigators hypothesize that in COVID-19 patients witch anosmia the brain mapping
      objectified by an MRI examination is modified and that there are functional abnormalities in
      the brain in these patients.
observational model: Case-Only
time perspective: Prospective
measure: Brain regional homogeneity between COVID-19 patients with and without anosmia
time frame: Day 0
description: MRI; Voxels
measure: Brain regional homogeneity between COVID-19 patients with and without anosmia
time frame: Month 3
description: MRI; Voxels
measure: Topography of supra- or sub-tentorial lesions between COVID-19 patients with and without anosmia
time frame: Day 0
description: MRI; Voxels
measure: Fractional anisotropy between COVID-19 patients with and without anosmia
time frame: Day 0
description: MRI; voxels, value between 0-1
measure: Fractional anisotropy between COVID-19 patients with and without anosmia
time frame: Month 3
description: MRI; voxels, value between 0-1
measure: Mean diffusivity between COVID-19 patients with and without anosmia
time frame: Day 0
description: MRI; mm2/s
measure: Mean diffusivity between COVID-19 patients with and without anosmia
time frame: Month 3
description: MRI; mm2/s
measure: Radial diffusivity between COVID-19 patients with and without anosmia
time frame: Day 0
description: MRI; mm2/s
measure: Radial diffusivity between COVID-19 patients with and without anosmia
time frame: Month 3
description: MRI; mm2/s
measure: Self-assessed olfactory and gustatory test
time frame: Day 0
description: Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today
measure: Self-assessed olfactory and gustatory test
time frame: Day 8
description: Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today
measure: Self-assessed olfactory and gustatory test
time frame: Month 1
description: Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today
measure: Self-assessed olfactory and gustatory test
time frame: Month 2
description: Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today
measure: Ability to detect odor
time frame: Day 0
description: Ability to smell 1.5ml air freshner on a 0-100 VAS scale (cut-offs: strang (>80), moderate (40-80), attenuated (<40)
measure: Ability to taste a pinch of sugar
time frame: Day 0
description: Patient asked to describe whether a pinch of sugar on their tongue taste sweet or salty
measure: Presence of thrombotic and hemorrhagic lesions
time frame: Day 0
description: MRI: absence/presence
measure: Presence of thrombotic and hemorrhagic lesions
time frame: Month 3
description: MRI: absence/presence
measure: Presence of lesions with hyperintensity
time frame: Day 0
description: Short Ti Inversion Recovery (STIR); presence/absence
measure: Presence of lesions with hyperintensity
time frame: Month 3
description: Short Ti Inversion Recovery (STIR); presence/absence
measure: Projection network analysis of all patients
time frame: Day 0
description: beta voxels
measure: Projection network analysis of all patients
time frame: Month 3
description: beta voxels
measure: Blinded independent component analysis of all patients
time frame: Day 0
description: beta voxels
measure: Blinded independent component analysis of all patients
time frame: Month 3
description: beta voxels
measure: default mode network analysis of all patients
time frame: Day 0
description: beta voxels
measure: default mode network analysis of all patients
time frame: Month 3
description: beta voxels
measure: executive control network analysis of all patients
time frame: Day 0
description: beta voxels
measure: executive control network analysis of all patients
time frame: Month 3
description: beta voxels
arm group label: COVID-19 patients with anosmia
description: Patients reporting loss of smell and scoring < 30 on a VAS 0-100 for ability to detect n-Butanol diluted 1/1000
arm group label: COVID-19 patients without anosmia
description: Patients reporting no loss of smell and scoring > 80 on a VAS 0-100 for ability to detect n-Butanol diluted 1/16000
intervention type: Other
intervention name: Brain MRI scan
description: Resting state, functional, structural and morphometric MRI; diffusion tensor imaging on a 3-Tesla MRI scanner
arm group label: COVID-19 patients with anosmia
arm group label: COVID-19 patients without anosmia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Lallemant
role: Principal Investigator
affiliation: CHU Nimes
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Anosmia