<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/NCT04466982</url>
  </required_header>
  <id_info>
    <org_study_id>REC Ref: 20/SC/0231</org_study_id>
    <nct_id>NCT04466982</nct_id>
  </id_info>
  <brief_title>Assessment of Olfactory Dysfunction in SARS CoV-2 (COVID-19) Infection</brief_title>
  <acronym>ODYSSI</acronym>
  <official_title>Objective Assessment of Olfactory Dysfunction and Impact on Quality of Life in SARS CoV-2 (COVID-19)Infection Using the UPSIT, eQOD and SNOT-22 Questionnaires: A Prospective Observational Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Imperial College Healthcare NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Cornwall Hospitals Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cambridge University Hospitals NHS Foundation Trust</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>
      This study is designed to investigate the acuity of olfactory dysfunction in COVID-19&#xD;
      positive patients in the United Kingdom. In particular defining severity with objective&#xD;
      testing and determining if this has any predictive value on the outcome of the SARS CoV-2&#xD;
      infection. In addition, this study will strive to determine duration / natural history of&#xD;
      olfactory dysfunction in these patients in respect to a positive SARS CoV-2 diagnosis. It&#xD;
      should also demonstrate the impact of olfactory dysfunction on patient Quality of Life (QOL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of this study is to evaluate olfactory acuity by means of a&#xD;
      multidimensional assessment protocol to objectively demonstrate the severity of olfactory&#xD;
      dysfunction in patients diagnosed with SARS CoV-2. The University of Pennsylvania Smell&#xD;
      Identification Test (UPSIT) will be used to assess olfactory function in newly diagnosed&#xD;
      patients and also existing patients longitudinally over a 12-month period. This is to&#xD;
      document onset (where possible) and rate of progress of olfactory dysfunction.&#xD;
&#xD;
      In relevant cases, the investigators will correlate their findings with severity of the Acute&#xD;
      Respiratory Distress Syndrome (ARDS) arising as a result of the infection - characterised as&#xD;
      mild, moderate and severe according to the Berlin classification. The investigators will&#xD;
      therefore determine if the degree of olfactory dysfunction correlates in any manner to the&#xD;
      severity of ARDS developed in a positive SARS CoV-2 patient and if it offers any&#xD;
      prognosticative applications.&#xD;
&#xD;
      The investigators will also examine the impact of the symptom of olfactory dysfunction on&#xD;
      patient Quality of Life using two validated tools known as the Questionnaire of Olfactory&#xD;
      Disorders for English speakers (eQOD) and the SNOT-22 questionnaire.&#xD;
&#xD;
      Furthermore, outcomes will be explored and stratified in terms of age, gender and ethnicity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2021</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>UPSIT scores</measure>
    <time_frame>At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study</time_frame>
    <description>I. Primary endpoint is olfactory function assessed using the UPSIT and classified as Anosmia; Mild, moderate, and severe microsomia. assessed at the time COVID-19 diagnosis (+1 week) or at the time of registration for in hospital patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>UPSIT scores</measure>
    <time_frame>at day 0, 1 month, 3 month, 6 month, 9 month and 12 month</time_frame>
    <description>I. The changes in olfaction in patients with SARS CoV-2 infection over an initial 12 month period (at day 0, 1 month, 3 month, 6 month, 9 month and 12 month) using the UPSIT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>eQOD scores</measure>
    <time_frame>at day 0, 1 month, 3 month, 6 month, 9 month and 12 month</time_frame>
    <description>Quality of Life using the validated Questionnaire of Olfactory Disorders for English speakers (eQOD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SNOT 22 scores</measure>
    <time_frame>at day 0, 1 month, 3 month, 6 month, 9 month and 12 month</time_frame>
    <description>Quality of Life using the validated SinoNasal Outcome Tool-22 (SNOT-22)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Olfactory Disorder</condition>
  <condition>COVID19</condition>
  <condition>SARS-CoV-2</condition>
  <condition>Anosmia</condition>
  <condition>Microsomia</condition>
  <condition>Smell Disorder</condition>
  <condition>Quality of Life</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study group will comprise patients diagnosed with the SARS Cov-2 infection at the local&#xD;
        site.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are presenting to hospital with symptoms of SARS CoV-2 infection.&#xD;
&#xD;
          -  Patients who go on to develop a positive SARS CoV-2 test.&#xD;
&#xD;
          -  Patients who can give a valid written informed consent.&#xD;
&#xD;
          -  Patients who are motivated to participate in the study.&#xD;
&#xD;
          -  Adult patients aged 18 years - 85 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who cannot give a valid written informed consent.&#xD;
&#xD;
          -  Patients who are not willing or not motivated to participate in the study.&#xD;
&#xD;
          -  Patients with negative SARS CoV-2 tests.&#xD;
&#xD;
          -  Patients with nasal pathologies like severe deviated nasal septum, nasal masses, head&#xD;
             trauma or previously known chronic rhinosinusitis with polyps or on medication for&#xD;
             more than 6 months/year for at least one year for chronic rhinosinusitis.&#xD;
&#xD;
          -  Patients with any diagnosed neurological disease known to affect olfactory function&#xD;
             will be excluded from the study.&#xD;
&#xD;
          -  Patients unable to read in the English language.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Addenbrookes Hospital</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Kyd, FRCS (ORL-HNS)</last_name>
      <phone>01223 245151</phone>
      <email>Rachel.Kyd@addenbrookes.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Ekpemi Irune, FRCS (ORL-HNS)</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rishi Sharma, FRCS (ORL-HNS)</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kristian Hutson, FRCS (ORL-HNS)</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Charing Cross Hospital</name>
      <address>
        <city>London</city>
        <zip>W6 8RF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Omolade Awomolo</last_name>
      <phone>020 3313 7306</phone>
      <email>Omolade.Awomolo@nhs.net</email>
    </contact>
    <investigator>
      <last_name>Catherine Rennie, FRCS (ORL-HNS)</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hesham Saleh, FRCS (ORL-HNS)</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospital</name>
      <address>
        <city>Truro</city>
        <zip>TR1 3LQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gina Townley</last_name>
      <phone>01872 256429</phone>
      <email>gina.townley@nhs.net</email>
    </contact>
    <investigator>
      <last_name>Neil Tan, FRCS (ORL-HNS)</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 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>December 10, 2020</last_update_submitted>
  <last_update_submitted_qc>December 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cambridge University Hospitals NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Ekpemi Irune</investigator_full_name>
    <investigator_title>Consultant in Otolaryngology, Head &amp; Neck Surgery</investigator_title>
  </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>
    <mesh_term>Olfaction Disorders</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/NCT04466982
org study id: REC Ref: 20/SC/0231
nct id: NCT04466982
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study is designed to investigate the acuity of olfactory dysfunction in COVID-19
      positive patients in the United Kingdom. In particular defining severity with objective
      testing and determining if this has any predictive value on the outcome of the SARS CoV-2
      infection. In addition, this study will strive to determine duration / natural history of
      olfactory dysfunction in these patients in respect to a positive SARS CoV-2 diagnosis. It
      should also demonstrate the impact of olfactory dysfunction on patient Quality of Life (QOL).
The main objective of this study is to evaluate olfactory acuity by means of a
      multidimensional assessment protocol to objectively demonstrate the severity of olfactory
      dysfunction in patients diagnosed with SARS CoV-2. The University of Pennsylvania Smell
      Identification Test (UPSIT) will be used to assess olfactory function in newly diagnosed
      patients and also existing patients longitudinally over a 12-month period. This is to
      document onset (where possible) and rate of progress of olfactory dysfunction.

      In relevant cases, the investigators will correlate their findings with severity of the Acute
      Respiratory Distress Syndrome (ARDS) arising as a result of the infection - characterised as
      mild, moderate and severe according to the Berlin classification. The investigators will
      therefore determine if the degree of olfactory dysfunction correlates in any manner to the
      severity of ARDS developed in a positive SARS CoV-2 patient and if it offers any
      prognosticative applications.

      The investigators will also examine the impact of the symptom of olfactory dysfunction on
      patient Quality of Life using two validated tools known as the Questionnaire of Olfactory
      Disorders for English speakers (eQOD) and the SNOT-22 questionnaire.

      Furthermore, outcomes will be explored and stratified in terms of age, gender and ethnicity
observational model: Cohort
time perspective: Prospective
measure: UPSIT scores
time frame: At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study
description: I. Primary endpoint is olfactory function assessed using the UPSIT and classified as Anosmia; Mild, moderate, and severe microsomia. assessed at the time COVID-19 diagnosis (+1 week) or at the time of registration for in hospital patients
measure: UPSIT scores
time frame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
description: I. The changes in olfaction in patients with SARS CoV-2 infection over an initial 12 month period (at day 0, 1 month, 3 month, 6 month, 9 month and 12 month) using the UPSIT.
measure: eQOD scores
time frame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
description: Quality of Life using the validated Questionnaire of Olfactory Disorders for English speakers (eQOD)
measure: SNOT 22 scores
time frame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
description: Quality of Life using the validated SinoNasal Outcome Tool-22 (SNOT-22)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Cambridge University Hospitals NHS Foundation Trust
investigator full name: Ekpemi Irune
investigator title: Consultant in Otolaryngology, Head & Neck Surgery
mesh term: COVID-19
mesh term: Anosmia
mesh term: Olfaction Disorders
sharing ipd: No