COVID19 Clinical Trial
— ODYSSIOfficial 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
Verified date | December 2020 |
Source | Cambridge University Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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).
Status | Recruiting |
Enrollment | 90 |
Est. completion date | January 2022 |
Est. primary completion date | August 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Addenbrookes Hospital | Cambridge | |
United Kingdom | Charing Cross Hospital | London | |
United Kingdom | Royal Cornwall Hospital | Truro |
Lead Sponsor | Collaborator |
---|---|
Cambridge University Hospitals NHS Foundation Trust | Imperial College Healthcare NHS Trust, Royal Cornwall Hospitals Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study | |
Secondary | 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. | at day 0, 1 month, 3 month, 6 month, 9 month and 12 month | |
Secondary | eQOD scores | Quality of Life using the validated Questionnaire of Olfactory Disorders for English speakers (eQOD) | at day 0, 1 month, 3 month, 6 month, 9 month and 12 month | |
Secondary | SNOT 22 scores | Quality of Life using the validated SinoNasal Outcome Tool-22 (SNOT-22) | at day 0, 1 month, 3 month, 6 month, 9 month and 12 month |
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