CClinicalTrials.gg
CompletedNCT05246059COVANOSUpdated Feb 18, 2022

Anosmia and Covid-19

An interventional study of Olfactory Training in Anosmia and SARS CoV 2 Infection, sponsored by University College, London. Completed at 4 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-18.

Sponsored by University College, London · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jun 2020, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Our study aims to determine the prevalence of anosmia in patients SARS-Cov-2/Covid-19 infection (both by symptom reporting and smell testing), the efficacy of early olfactory training for the treatment of anosmia caused by infection and the long-term impact of smell dysfunction with a one-year follow-up.

Read the detailed description

Around 10-15% of patients with acquired anosmia have Post Viral Olfactory Loss (PVOL). Coronaviruses are a known cause for anosmia. At the onset of the COVID-19 pandemic, reports from China, South Korea, US and Europe suggest that a significant proportion of COVID-19 patients describe a loss of smell and taste as the only symptoms or as part of mild flu-like symptoms. It is now well-established that these symptoms are important components of the COVID-19 sequelae with persistent dysfunction described in a subset of individuals.

For this study, individuals, mainly comprising mainly healthcare workers in the UK, with persistent and sudden loss of sense of smell (at least 4 weeks) were recruited to ascertain the prevalence of COVID-19 associated smell dysfunction. A positive COVID-19 test was not a requirement for participation if not readily available nor accessible, however, information regarding COVID-19 antigen and antibody testing was collected post-hoc from those for who data are readily available. All participants (n=227) underwent initial psychophysical smell testing using the Brief Smell Identification Test (BSIT), gustatory testing using Taste Strips and completed the Smell Qx questionnaire. This questionnaire collected relevant demographic information, medical history, details of COVID-19 symptoms experienced, as well as information on olfactory and gustatory function, including those related to quality-of-life.

Participants, who scored 8 or below on the BSIT (indicative of semi-quantitative smell loss) were further invited to participate in the early olfactory training randomized controlled trial. Participants were randomized to undergo either 12 weeks of olfactory training or receive safety information. At the end of the 12-weeks, participants completed a follow-up BSIT and survey.

All participants enrolled at baseline within the eligible timeframe, for whom a valid email address was available, were further invited to participate in 1 year follow-up assessments. This included all participants irrespective of baseline BSIT result and RCT participation. The follow-up included a final electronic survey and BSIT. In addition to questions related to their sense of smell, which were identical to those in the baseline and 12-week follow-up surveys, participants were also asked about any symptoms of long-Covid.

02

Conditions studied

  • Anosmia
  • SARS CoV 2 Infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 63 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed (positive laboratory antigen test) or suspected COVID-19 infection
  • Sudden onset of smell loss
  • Smell loss of at least 4 weeks
  • Reduced smell function through psycho-physical testing (Brief Smell Identification Test score of 8 or less)

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • No intervention
    Control

    12 weeks of observation, safety information provided

  • Experimental
    Treatment

    12-weeks of daily olfactory training

    Other: Olfactory Training

Interventions

  • OtherOlfactory Training

    Sniffin' Sticks (Duft-Quartett, Burghart Messtechnik, GmbH, Germany)

06

What researchers measure

Primary outcomes

  1. Brief Smell Identification Test (BSIT)

    The absolute difference between the intervention and control arms in BSIT score smell improvement, measured as a change from baseline at 12-weeks.

    Time frame: 12-weeks

Secondary outcomes

  1. Quality of Life Score

    Within subject changes to scoring of questionnaire quality of life items at 12-weeks compared to baseline

    Time frame: 12-weeks

  2. Compliance (anecdotal)

    Participant compliance to olfactory training through anecdotal reporting

    Time frame: 12-weeks

  3. Safety (anecdotal)

    Safety of the use of Sniffin' Sticks through anecdotal reporting

    Time frame: 12-weeks

07

Study locations

4 sites
  • Barts Health NHS Foundation Trust
    London, England, United Kingdom
  • Guy's and St. Thomas' NHS Foundation Trust
    London, England, United Kingdom
  • Wrightington, Wigan and Leigh NHS Foundation Trust
    Wigan, England, United Kingdom
  • James Paget and Norfolk & Norwich University Hospitals
    Gorleston-on-Sea, Great Yarmouth, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05246059
Lead sponsor
University College, London
Responsible party
Sponsor
First posted
Feb 18, 2022
Start date
Jun 3, 2020
Primary completion
Aug 8, 2021
Completion
Aug 8, 2021
Last update
Feb 18, 2022

Study contacts

Valerie J. Lund, MD FRCS
principal investigator · University College, London
Matt Lechner, MD FRCS
principal investigator · University College London, Barts Health NHS Foundation Trust

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion