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

Sponsor

Cambridge University Hospitals NHS Foundation Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT04466982

Collaborator

Imperial College Healthcare NHS Trust (Other), Royal Cornwall Hospitals Trust (Other)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Type:

Observational

Anticipated 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 :

Jul 2, 2020

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

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

Locations

	Site	City	Country	Postal Code
1	Addenbrookes Hospital	Cambridge	United Kingdom	CB2 0QQ
2	Charing Cross Hospital	London	United Kingdom	W6 8RF
3	Royal Cornwall Hospital	Truro	United Kingdom	TR1 3LQ

Sponsors and Collaborators

Cambridge University Hospitals NHS Foundation Trust
Imperial College Healthcare NHS Trust
Royal Cornwall Hospitals Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jul 10, 2020

Last Update Posted:

Dec 14, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2020