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NCT Number: NCT04466982

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

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).

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Key information

Conditions

Olfactory Disorder Anosmia COVID-19 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronaviridae Infections Coronavirus Infections Covid19 Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Infections Lung Diseases Microsomia Nervous System Diseases Neurologic Manifestations Nidovirales Infections Olfaction Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Pregnancy Complications Quality of Life RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Sensation Disorders Signs and Symptoms Smell Disorder Urogenital Diseases Virus Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Addenbrookes Hospital, Cambridge, United Kingdom

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About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Collaborators

  • Imperial College Healthcare NHS Trust
  • Royal Cornwall Hospitals Trust

Registry information

Official study 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

Acronym: ODYSSI

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 10, 2020
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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