AnosmiaCOVANOSNCT05246059
Anosmia and Covid-19
A study testing Olfactory Training in people with Anosmia and SARS CoV 2 Infection, run by University College, London at 4 sites in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anosmia, SARS CoV 2 Infection
- What is being tested?
- Olfactory Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 3 Jun 2020to 8 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- -
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
James Paget and Norfolk & Norwich University Hospitals
Gorleston-on-Sea, Great Yarmouth
Barts Health NHS Foundation Trust
London, England
Guy's and St. Thomas' NHS Foundation Trust
London, England
Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan, England
About this study
Official title: SARS-CoV-2 Infection/Covid-19 and Anosmia - Prevalence Study, Molecular Analysis and Clinical Trial
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.
- Conditions
- Anosmia, SARS CoV 2 Infection
- Being tested
- Olfactory Training
- Medical subject headings
- Anosmia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory TrainingOther
Sniffin' Sticks (Duft-Quartett, Burghart Messtechnik, GmbH, Germany)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 12 weeks of observation, safety information provided |
| Treatment | Experimental | 12-weeks of daily olfactory training Receives: Other: Olfactory Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-weeks
Secondary outcomes (3)
Quality of Life Score
Within subject changes to scoring of questionnaire quality of life items at 12-weeks compared to baseline
Measured: 12-weeks
Compliance (anecdotal)
Participant compliance to olfactory training through anecdotal reporting
Measured: 12-weeks
Safety (anecdotal)
Safety of the use of Sniffin' Sticks through anecdotal reporting
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start3 Jun 2020
- Primary completion8 Aug 2021
- Study completion8 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnosmiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie J. Lund, MD FRCS, Principal investigator, University College, LondonMatt Lechner, MD FRCS, Principal investigator, University College London, Barts Health NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246059
- Sponsor's protocol ID
- EDGE132692
- Other IDs
- IRAS No. 283758
- Acronym
- COVANOS
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Infection/Covid-19 and Anosmia - Prevalence Study, Molecular Analysis and Clinical Trial
- ClinicalTrials.gov ID
- NCT05246059
- Acronym / sponsor ID
- COVANOS / EDGE132692
- Conditions
- Anosmia, SARS CoV 2 Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 8 Aug 2021 (actual)
- Study completion
- 8 Aug 2021 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –12 weeks of observation, safety information provided |
| Treatment | Experimental | Other: Olfactory Training12-weeks of daily olfactory training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olfactory TrainingSniffin' Sticks (Duft-Quartett, Burghart Messtechnik, GmbH, Germany) | Other | Treatment |
Primary outcome
Brief Smell Identification Test (BSIT)
Time frame: 12-weeks
The absolute difference between the intervention and control arms in BSIT score smell improvement, measured as a change from baseline at 12-weeks.
3 secondary outcomes
Quality of Life Score
Time frame: 12-weeks
Compliance (anecdotal)
Time frame: 12-weeks
Safety (anecdotal)
Time frame: 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie J. Lund, MD FRCS principal investigator
University College, London
Matt Lechner, MD FRCS principal investigator
University College London, Barts Health NHS Foundation Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olfactory Training in people with Anosmia and SARS CoV 2 Infection, run by University College, London at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Smell Identification Test (BSIT) (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.