<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/NCT04445597</url>
  </required_header>
  <id_info>
    <org_study_id>S64042</org_study_id>
    <nct_id>NCT04445597</nct_id>
  </id_info>
  <brief_title>ANalyzing Olfactory Dysfunction Mechanisms In COVID-19</brief_title>
  <acronym>ANOSMIC-19</acronym>
  <official_title>ANalyzing Olfactory Dysfunction Mechanisms In COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Max Planck Research Unit for Neurogenetics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AZ Sint-Jan Brugge-Oostende AV</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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>
      We aim to understand the mechanism of olfactory dysfunction in COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In December 2019, a new coronavirus causing severe acute respiratory syndrome was described&#xD;
      in Wuhan, China. This virus, later named severe acute respiratory syndrome coronavirus 2&#xD;
      (SARS-CoV-2), spread worldwide and has been designated a pandemic by the World Health&#xD;
      Organization.&#xD;
&#xD;
      By the beginning of March 2020, several Ear, Nose, Throat societies raised awareness of a&#xD;
      frequent association between coronavirus disease 2019 (COVID-19) and smell disorders.&#xD;
&#xD;
      In the present study, the investigators wish to begin to understand the pathogenesis of&#xD;
      olfactory dysfunction in COVID-19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 7, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of SARS-CoV-2 in the sampled tissue</measure>
    <time_frame>Immediately after death</time_frame>
    <description>In the sampled tissues, the investigators will determine presence of SARS-CoV-2 by means of immunohistochemistry, RNA-scope and spatial transcriptomics</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>SARS-CoV-2</condition>
  <arm_group>
    <arm_group_label>COVID-19 positive or negative patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Hospitalised patients with or without COVID-19 (with or without olfactory dysfunctions)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sampling of tissue</intervention_name>
    <description>In all groups of participants, tissue from the nasal cavity and olfactory system will be surgically removed</description>
    <arm_group_label>COVID-19 positive or negative patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Deceased hospitalised patients, tested positive or negative for SARS-CoV-2 for patient or&#xD;
        control group respectively&#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>Laura Van Gerven</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ/KU Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laura Van Gerven</last_name>
    <phone>+3216336342</phone>
    <email>laura.vangerven@uzleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marnick Clijsters</last_name>
    <phone>+3216336342</phone>
    <email>marnick.clijsters@kuleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Van Gerven, Doctor</last_name>
      <phone>+3216336342</phone>
      <email>laura.vangerven@uzleuven.be</email>
    </contact>
    <contact_backup>
      <last_name>Marnick Clijsters</last_name>
      <phone>+3216336342</phone>
      <email>marnick.clijsters@uzleuven.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>May 26, 2023</last_update_submitted>
  <last_update_submitted_qc>May 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Laura Van Gerven</investigator_full_name>
    <investigator_title>Professor doctor</investigator_title>
  </responsible_party>
  <keyword>Hyposmia</keyword>
  <keyword>Anosmia</keyword>
  <keyword>Olfactory Dysfunction</keyword>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <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>No</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/NCT04445597
org study id: S64042
nct id: NCT04445597
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
We aim to understand the mechanism of olfactory dysfunction in COVID-19.
In December 2019, a new coronavirus causing severe acute respiratory syndrome was described
      in Wuhan, China. This virus, later named severe acute respiratory syndrome coronavirus 2
      (SARS-CoV-2), spread worldwide and has been designated a pandemic by the World Health
      Organization.

      By the beginning of March 2020, several Ear, Nose, Throat societies raised awareness of a
      frequent association between coronavirus disease 2019 (COVID-19) and smell disorders.

      In the present study, the investigators wish to begin to understand the pathogenesis of
      olfactory dysfunction in COVID-19.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Prevalence of SARS-CoV-2 in the sampled tissue
time frame: Immediately after death
description: In the sampled tissues, the investigators will determine presence of SARS-CoV-2 by means of immunohistochemistry, RNA-scope and spatial transcriptomics
arm group label: COVID-19 positive or negative patients
arm group type: Other
description: Hospitalised patients with or without COVID-19 (with or without olfactory dysfunctions)
intervention type: Other
intervention name: Sampling of tissue
description: In all groups of participants, tissue from the nasal cavity and olfactory system will be surgically removed
arm group label: COVID-19 positive or negative patients
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Laura Van Gerven
role: Principal Investigator
affiliation: UZ/KU Leuven
last name: Laura Van Gerven
phone: +3216336342
email: laura.vangerven@uzleuven.be
last name: Marnick Clijsters
phone: +3216336342
email: marnick.clijsters@kuleuven.be
facility: 
status: Recruiting
contact: 
contact backup: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Laura Van Gerven
investigator title: Professor doctor
mesh term: COVID-19
sharing ipd: No