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

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

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).

Study Overview

• Status: Completed
• Conditions: Quality of Life; Anosmia; SARS-CoV-2; COVID19; Olfactory Disorder; Microsomia; Smell Disorder

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 Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • Truro, United Kingdom, TR1 3LQ
    • Royal Cornwall Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study group will comprise patients diagnosed with the SARS Cov-2 infection at the local site.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UPSIT scores	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	At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UPSIT scores	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.	at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
eQOD scores	Quality of Life using the validated Questionnaire of Olfactory Disorders for English speakers (eQOD)	at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
SNOT 22 scores	Quality of Life using the validated SinoNasal Outcome Tool-22 (SNOT-22)	at day 0, 1 month, 3 month, 6 month, 9 month and 12 month

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: Imperial College Healthcare NHS Trust; Royal Cornwall Hospitals Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Sensation Disorders; COVID-19; Anosmia; Olfaction Disorders
• Other Study ID Numbers: REC Ref: 20/SC/0231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No