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

COVID19 Clinical Trial

— ODYSSI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04466982
• Other study ID #: REC Ref: 20/SC/0231
• Status: Recruiting
• Start date: July 2, 2020
• Est. completion date: January 2022

Study information

• Verified date: December 2020
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2022
• Est. primary completion date: August 2021
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anosmia
• COVID19
• Disease
• Microsomia
• Olfaction Disorders
• Olfactory Disorder
• Quality of Life
• SARS-CoV-2
• Smell Disorder

Locations

Country	Name	City	State
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Charing Cross Hospital	London
United Kingdom	Royal Cornwall Hospital	Truro

Sponsors (3)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	Imperial College Healthcare NHS Trust, Royal Cornwall Hospitals Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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