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Assessment of Olfactory Dysfunction in SARS CoV-2 (COVID-19) Infection (ODYSSI)

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ClinicalTrials.gov Identifier: NCT04466982
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : December 14, 2020
Sponsor:
Collaborators:
Imperial College Healthcare NHS Trust
Royal Cornwall Hospitals Trust
Information provided by (Responsible Party):
Ekpemi Irune, Cambridge University Hospitals NHS Foundation Trust

Study Description
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Brief Summary:
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).

Condition or disease
Olfactory Disorder COVID19 SARS-CoV-2 Anosmia Microsomia Smell Disorder Quality of Life

Detailed Description:

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

Study Design
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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 2, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : January 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. UPSIT scores [ Time Frame: At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study ]
    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


Secondary Outcome Measures :
  1. UPSIT scores [ Time Frame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month ]
    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.

  2. eQOD scores [ Time Frame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month ]
    Quality of Life using the validated Questionnaire of Olfactory Disorders for English speakers (eQOD)

  3. SNOT 22 scores [ Time Frame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month ]
    Quality of Life using the validated SinoNasal Outcome Tool-22 (SNOT-22)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study group will comprise patients diagnosed with the SARS Cov-2 infection at the local site.
Criteria

Inclusion Criteria:

  • Patients who are presenting to hospital with symptoms of SARS CoV-2 infection.
  • Patients who go on to develop a positive SARS CoV-2 test.
  • Patients who can give a valid written informed consent.
  • Patients who are motivated to participate in the study.
  • Adult patients aged 18 years - 85 years.

Exclusion Criteria:

  • Patients who cannot give a valid written informed consent.
  • Patients who are not willing or not motivated to participate in the study.
  • Patients with negative SARS CoV-2 tests.
  • Patients with nasal pathologies like severe deviated nasal septum, nasal masses, head trauma or previously known chronic rhinosinusitis with polyps or on medication for more than 6 months/year for at least one year for chronic rhinosinusitis.
  • Patients with any diagnosed neurological disease known to affect olfactory function will be excluded from the study.
  • Patients unable to read in the English language.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466982


Locations
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United Kingdom
Addenbrookes Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Rachel Kyd, FRCS (ORL-HNS)    01223 245151    Rachel.Kyd@addenbrookes.nhs.uk   
Principal Investigator: Ekpemi Irune, FRCS (ORL-HNS)         
Sub-Investigator: Rishi Sharma, FRCS (ORL-HNS)         
Sub-Investigator: Kristian Hutson, FRCS (ORL-HNS)         
Charing Cross Hospital Recruiting
London, United Kingdom, W6 8RF
Contact: Omolade Awomolo    020 3313 7306    Omolade.Awomolo@nhs.net   
Principal Investigator: Catherine Rennie, FRCS (ORL-HNS)         
Sub-Investigator: Hesham Saleh, FRCS (ORL-HNS)         
Royal Cornwall Hospital Recruiting
Truro, United Kingdom, TR1 3LQ
Contact: Gina Townley    01872 256429    gina.townley@nhs.net   
Principal Investigator: Neil Tan, FRCS (ORL-HNS)         
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Imperial College Healthcare NHS Trust
Royal Cornwall Hospitals Trust
More Information
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Responsible Party: Ekpemi Irune, Consultant in Otolaryngology, Head & Neck Surgery, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04466982    
Other Study ID Numbers: REC Ref: 20/SC/0231
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Olfaction Disorders
Disease
Pathologic Processes
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases