Olfactory DisorderODYSSINCT04466982
Assessment of Olfactory Dysfunction in SARS CoV-2 (COVID-19) Infection
An observational study of Olfactory Disorder and COVID19, run by Cambridge University Hospitals NHS Foundation Trust at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Olfactory Disorder, COVID19, SARS-CoV-2
- How many people
- 81 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 2 Jul 2020to 30 Mar 2023
- Phase
- Observational
- 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 to 85 years
- All sexes
- Adult, Older adult
Study population: The study group will comprise patients diagnosed with the SARS Cov-2 infection at the local site.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Addenbrookes Hospital
Cambridge, CB2 0QQ
Charing Cross Hospital
London, W6 8RF
Royal Cornwall Hospital
Truro, TR1 3LQ
About this study
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
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).
Read the 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
- Conditions
- Olfactory Disorder, COVID19, SARS-CoV-2, Anosmia, Microsomia, Smell Disorder
- Medical subject headings
- COVID-19, Anosmia, Fetal Growth Retardation, Olfaction Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
UPSIT scores
- Primary endpoint is olfactory function assessed using the UPSIT and classified as Anosmia; Mild, moderate, and severe microsomia. assessed at the time COVID-19 diagnosis (+1 week) or at the time of registration for in hospital patients
Measured: At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study
Secondary outcomes (3)
UPSIT scores
- The changes in olfaction in patients with SARS CoV-2 infection over an initial 12 month period (at day 0, 1 month, 3 month, 6 month, 9 month and 12 month) using the UPSIT.
Measured: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
eQOD scores
Quality of Life using the validated Questionnaire of Olfactory Disorders for English speakers (eQOD)
Measured: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
SNOT 22 scores
Quality of Life using the validated SinoNasal Outcome Tool-22 (SNOT-22)
Measured: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start2 Jul 2020
- Primary completion30 Dec 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfactory DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Royal Cornwall Hospitals Trust
- Responsible party
- Principal investigator, Ekpemi Irune, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466982
- Sponsor's protocol ID
- REC Ref: 20/SC/0231
- Acronym
- ODYSSI
- Status last verified
- Jun 2025
- First submitted
- 9 Jul 2020
- Last updated
- 29 Jun 2025
- 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04466982
- Acronym / sponsor ID
- ODYSSI / REC Ref: 20/SC/0231
- Conditions
- Olfactory Disorder, COVID19, SARS-CoV-2, Anosmia, Microsomia, Smell Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Royal Cornwall Hospitals Trust
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 10 Jul 2020 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study group will comprise patients diagnosed with the SARS Cov-2 infection at the local site.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
UPSIT scores
Time frame: At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study
I. Primary endpoint is olfactory function assessed using the UPSIT and classified as Anosmia; Mild, moderate, and severe microsomia. assessed at the time COVID-19 diagnosis (+1 week) or at the time of registration for in hospital patients
3 secondary outcomes
UPSIT scores
Time frame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
eQOD scores
Time frame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
SNOT 22 scores
Time frame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
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 29 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Olfactory Disorder and COVID19, run by Cambridge University Hospitals NHS Foundation Trust at 3 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 5 inclusion and 6 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 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
UPSIT scores (time frame: At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study). 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 29 Jun 2025.