An observational study in Olfactory Disorder, COVID19 and SARS-CoV-2, sponsored by Cambridge University Hospitals NHS Foundation Trust. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Observational
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).
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
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 81 is below the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 171 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study group will comprise patients diagnosed with the SARS Cov-2 infection at the local site.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
UPSIT scores
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
Time frame: At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study
UPSIT scores
I. 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.
Time frame: 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)
Time frame: 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)
Time frame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Cambridge University Hospitals NHS Foundation Trust →