Clinical trial NCT04466982: Assessment of Olfactory Dysfunction in SARS CoV-2 (COVID-19) Infection
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Olfactory Disorder
COVID19
SARS-CoV-2
Anosmia
Microsomia
Smell Disorder
Quality of Life
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
name: Royal Cornwall Hospitals Trust
First posted: 2020-07-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group will comprise patients diagnosed with the SARS Cov-2 infection at the local site.

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

Eligibility criteria: 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.

Primary outcomes:
measure: UPSIT scores
timeFrame: At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study
Secondary outcomes:
measure: UPSIT scores
timeFrame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
measure: eQOD scores
timeFrame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
measure: SNOT 22 scores
timeFrame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
References: