<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/NCT04407494</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0176</org_study_id>
    <nct_id>NCT04407494</nct_id>
  </id_info>
  <brief_title>Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders (COVID-19)</brief_title>
  <acronym>COVID-OLFA</acronym>
  <official_title>Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders in a Population Tested for COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Participants are healthcare workers and adult outpatients referred in a COVID-19 screening&#xD;
      center. Patients-reported symptoms are collected, then participants underwent a simple&#xD;
      olfactory test (CODA for Clinical Olfactory Dysfunction Assessment), prior to swabbing for&#xD;
      SARS-CoV-2 diagnosis (RT-PCR). We aimed to evaluate the prevalence of smell and taste&#xD;
      disorders, and to calculate the diagnostic value of patient-reported and clinically verified&#xD;
      smell disorders in persons with suspected COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic values of anosmia and ageusia for COVID-19</measure>
    <time_frame>at inclusion</time_frame>
    <description>Diagnostic values of anosmia and ageusia for COVID-19 with questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic values of CODA</measure>
    <time_frame>at inclusion</time_frame>
    <description>Diagnostic values of CODA (Clinical Olfactory dysfunction Assessment) score for COVID-19 : Simple, fast, semi-objective olfactory test developed for epidemic context</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">809</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>COVID-19</arm_group_label>
    <description>Healthcare workers and adult outpatients attending the COVID-19 screening center of the University Hospital of Montpellier, France.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Reporting of anosmia, ageusia and other clinical symptoms</intervention_name>
    <description>Reporting of anosmia, ageusia and other clinical symptoms related to COVID-19 - CODA test - SARS-CoV2 RT-PCR and ELISA</description>
    <arm_group_label>COVID-19</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      NC&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthcare workers and adult outpatients attending the COVID-19 screening center of the&#xD;
        University Hospital of Montpellier, France.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Symptoms compatible with COVID-19&#xD;
&#xD;
          -  Close exposure to a confirmed COVID-19 index case&#xD;
&#xD;
          -  Ambulatory (asymptomatic, or if symptomatic, did not require hospitalisation, thus&#xD;
             with initial mild disease)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  known history of smell and taste disorders&#xD;
&#xD;
          -  testing inability (cognitive impairment, non native French speakers, test malingering)&#xD;
&#xD;
          -  testing contraindication (children, pregnancy, breastfeeding, specific allergies).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fréderic VENAIL, PU-PH</last_name>
    <role>Study Director</role>
    <affiliation>UH Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Diagnostic value</keyword>
  <keyword>Sensitivity</keyword>
  <keyword>Specificity</keyword>
  <keyword>Prevalence</keyword>
  <keyword>Positive predictive value</keyword>
  <keyword>Negative predictive value</keyword>
  <keyword>Epidemiology</keyword>
  <keyword>Diagnostic test</keyword>
  <keyword>Anosmia</keyword>
  <keyword>Ageusia</keyword>
  <keyword>Olfactory disorders</keyword>
  <keyword>Gustatory disorders</keyword>
  <keyword>Smell disorders</keyword>
  <keyword>Taste disorders</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>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04407494
org study id: RECHMPL20_0176
nct id: NCT04407494
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Participants are healthcare workers and adult outpatients referred in a COVID-19 screening
      center. Patients-reported symptoms are collected, then participants underwent a simple
      olfactory test (CODA for Clinical Olfactory Dysfunction Assessment), prior to swabbing for
      SARS-CoV-2 diagnosis (RT-PCR). We aimed to evaluate the prevalence of smell and taste
      disorders, and to calculate the diagnostic value of patient-reported and clinically verified
      smell disorders in persons with suspected COVID-19.
observational model: Cohort
time perspective: Prospective
measure: Diagnostic values of anosmia and ageusia for COVID-19
time frame: at inclusion
description: Diagnostic values of anosmia and ageusia for COVID-19 with questionnaire
measure: Diagnostic values of CODA
time frame: at inclusion
description: Diagnostic values of CODA (Clinical Olfactory dysfunction Assessment) score for COVID-19 : Simple, fast, semi-objective olfactory test developed for epidemic context
arm group label: COVID-19
description: Healthcare workers and adult outpatients attending the COVID-19 screening center of the University Hospital of Montpellier, France.
intervention type: Biological
intervention name: Reporting of anosmia, ageusia and other clinical symptoms
description: Reporting of anosmia, ageusia and other clinical symptoms related to COVID-19 - CODA test - SARS-CoV2 RT-PCR and ELISA
arm group label: COVID-19
NC
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fréderic VENAIL, PU-PH
role: Study Director
affiliation: UH Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided
ipd description: NC