Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000575932
Ethics application status
Approved
Date submitted
13/05/2020
Date registered
18/05/2020
Date last updated
18/05/2020
Date data sharing statement initially provided
18/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevalence of the loss of smell in patients with COVID-19: The SMELLY Study
Scientific title
Loss of SMELL as an earlY marker in patients with COVID-19
Secondary ID [1] 301227 0
Nil
Universal Trial Number (UTN)
Trial acronym
SMELLY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Olfactory dysfunction 317390 0
COVID-19 317391 0
Condition category
Condition code
Infection 315494 315494 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To determine the prevalence of olfactory dysfunction in patients with COVID-19 using the validated University of Pennsylvania Smell Identification Test (UPSIT).
The UPSIT test is delivered to the participant's residence(or place of isolation) with a request to self-administer the test as per instructions on the kit. A 15 min telephone visit with a study team member will occur on the same day.
The 15 min telephone visit will consist of asking questions regarding medical history, current symptoms, and the results of the UPSIT test.
Intervention code [1] 317531 0
Early Detection / Screening
Comparator / control treatment
Controls; subjects at least 18 yrs of age with a negative NAT (nucleic acid test) [nasopharyngeal or oropharyngeal swabs, faeces] for SARS-CoV2.
Control group
Active

Outcomes
Primary outcome [1] 323734 0
Prevalence of UPSIT score <26 (anosmia or severe hyposmia) in cases
Timepoint [1] 323734 0
The UPSIT test for each participant is assessed at a single visit. The study outcomes will be measured 6 months post-first patient recruited., when the study is expected to be completed.
Secondary outcome [1] 382751 0
Comparison of mean UPSIT scores in cases versus controls to determine average olfactory loss in COVID-19.
Timepoint [1] 382751 0
The comparison between mean UPSIT scores of COVID-19 positive patients and controls will be measured 6 months post-first patient recruited, when the study is expected to be completed.

Eligibility
Key inclusion criteria
Cases: patients with positive NAT (nucleic acid test) [nasopharyngeal or oropharyngeal swabs, faeces] for SARS-CoV2 and
(a) Aged 18 yrs and over
(b) in self-isolation and being monitored by the RNSH Virtual Hospital, or
(c) inpatient at RNSH with mild-moderate illness

Controls; subjects aged 18yrs and over with a negative NAT
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Patients admitted to ICU
(b) Patients who have had recent ENT surgery
(c) Patients on intra-nasal medications
(d) Patients with impaired cognition/dementia
(e) Patients with neurodegenerative diseases known to cause impaired olfaction
(f) Pregnant women
(g) Subjects aged less than 18 yrs

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
(1) Primary outcome: prevalence of study subjects with UPSIT score of <26 (anosmia or severe hyposmia)
(2) Secondary outcomes:
(a) Comparison of mean UPSIT scores between cases and controls (t-test)
(b) Correlation of UPSIT scores with demographics of patients with COVID-19 (age, gender, weight, smoking history, co-morbidities)
(c) Correlation of UPSIT scores with stage of COVID-19 diagnosis (early, mid, late, recovered)
(d) Identification of those odour groups from UPSIT most sensitive to the diagnosis of COVID-19
(e) Development of a rapid screening test using the most sensitive odours to the diagnosis of COVID-19, accounting for demographic variables and stage of infection, for use in the general population.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/05/2020
Date of last participant enrolment
Anticipated
31/08/2020
Actual
Date of last data collection
Anticipated
31/08/2020
Actual
Sample size
Target
100
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16631 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 30226 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 305678 0
Hospital
Name [1] 305678 0
Department of Endocrinology, Royal North Shore Hospital
Country [1] 305678 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Reserve Rd.,
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 306086 0
None
Name [1] 306086 0
Address [1] 306086 0
Country [1] 306086 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305958 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305958 0
C/-NSLHD Research Office
Kolling Institute
Reserve Rd.,
St Leonards NSW 2065
Ethics committee country [1] 305958 0
Australia
Date submitted for ethics approval [1] 305958 0
22/04/2020
Approval date [1] 305958 0
24/04/2020
Ethics approval number [1] 305958 0
2020/ETH00878

Summary
Brief summary
Olfactory dysfunction has emerged as a strong predictor of COVID-19, but data so far are based upon self-reported measures. We hypothesize that direct objective assessment of olfaction using a validated test kit will be even more highly sensitive to diagnosis of COVID-19, and that a screening test can therefore be developed for use in the general population to identify subjects who require self-isolation until COVID-19 can be excluded on nasal swab testing. For such a population-level point-of-care screening test, the most important attributes are sensitivity, safety, ease of use and reliability.
Our hypothesis is that normal olfaction (normosmia) using a highly sensitive odour test will reliably exclude COVID-19, and subjects with anosmia will be referred for additional testing (nasopharyngeal swab etc) to diagnose COVID-19. Such a strategy will be ideal in the next phase of Australia’s response to COVID-19, i.e. in track-and-trace identification.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 102210 0
A/Prof Roderick Clifton-Bligh
Address 102210 0
Department of Endocrinology, Diabetes, and Metabolism
Royal North Shore Hospital
Sr Leonards NSW 2065
Country 102210 0
Australia
Phone 102210 0
+61 2 9463 1680
Fax 102210 0
+61 2 9463 1046
Email 102210 0
[email protected]
Contact person for public queries
Name 102211 0
Ms Liza Nery
Address 102211 0
Department of Endocrinology, Diabetes, and Metabolism
Royal North Shore Hospital
Sr Leonards NSW 2065
Country 102211 0
Australia
Phone 102211 0
+61 2 9463 1864
Fax 102211 0
+61 2 9463 1046
Email 102211 0
[email protected]
Contact person for scientific queries
Name 102212 0
A/Prof Roderick Clifton-Bligh
Address 102212 0
Department of Endocrinology, Diabetes, and Metabolism
Royal North Shore Hospital
Sr Leonards NSW 2065
Country 102212 0
Australia
Phone 102212 0
+61 2 9463 1680
Fax 102212 0
+61 2 9463 1046
Email 102212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Principal Investigator
Available for what types of analyses?
To achieve the aims in the approved proposal or for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.