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Prevalence of the loss of smell in patients with COVID-19: The SMELLY Study

Loss of SMELL as an earlY marker in patients with COVID-19

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000575932
Acronym
SMELLY
Enrollment
4
Registered
2020-05-18
Start date
2020-05-03
Completion date
2020-08-31
Last updated
2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 symptom

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.

Sponsors

Royal North Shore Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026