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

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

• Registration Number: NCT04466982
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

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).

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 Timeline

• Study Start: 2020-07-02
• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-10
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-14
• Primary Completion: 2021-08
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
UPSIT scores	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

Name	Time	Method
UPSIT scores	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.
eQOD scores	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)
SNOT 22 scores	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)

Trial Locations

Locations (3)

Addenbrookes Hospital; 🇬🇧 Cambridge, United Kingdom

Royal Cornwall Hospital; 🇬🇧 Truro, United Kingdom

Charing Cross Hospital; 🇬🇧 London, United Kingdom