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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
| Royal Cornwall Hospitals Trust | OTHER |
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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
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| eQOD scores |
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Inclusion Criteria:
Exclusion Criteria:
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The study group will comprise patients diagnosed with the SARS Cov-2 infection at the local site.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom | |||
| Charing Cross Hospital |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000086582 | Anosmia |
| D005317 | Fetal Growth Retardation |
| D000857 | Olfaction Disorders |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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 |
| 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 |
| London |
| W6 8RF |
| United Kingdom |
| Royal Cornwall Hospital | Truro | TR1 3LQ | United Kingdom |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |