- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04466982
Assessment of Olfactory Dysfunction in SARS CoV-2 (COVID-19) Infection (ODYSSI)
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
Study Overview
Status
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Cambridge, United Kingdom, CB2 0QQ
- Recruiting
- Addenbrookes Hospital
-
Contact:
- Rachel Kyd, FRCS (ORL-HNS)
- Phone Number: 01223 245151
- Email: Rachel.Kyd@addenbrookes.nhs.uk
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Principal Investigator:
- Ekpemi Irune, FRCS (ORL-HNS)
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Sub-Investigator:
- Rishi Sharma, FRCS (ORL-HNS)
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Sub-Investigator:
- Kristian Hutson, FRCS (ORL-HNS)
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London, United Kingdom, W6 8RF
- Recruiting
- Charing Cross Hospital
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Contact:
- Omolade Awomolo
- Phone Number: 020 3313 7306
- Email: Omolade.Awomolo@nhs.net
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Principal Investigator:
- Catherine Rennie, FRCS (ORL-HNS)
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Sub-Investigator:
- Hesham Saleh, FRCS (ORL-HNS)
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Truro, United Kingdom, TR1 3LQ
- Recruiting
- Royal Cornwall Hospital
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Contact:
- Gina Townley
- Phone Number: 01872 256429
- Email: gina.townley@nhs.net
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Principal Investigator:
- Neil Tan, FRCS (ORL-HNS)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
UPSIT scores
Time Frame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
|
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.
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at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
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eQOD scores
Time Frame: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
|
Quality of Life using the validated Questionnaire of Olfactory Disorders for English speakers (eQOD)
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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
|
Quality of Life using the validated SinoNasal Outcome Tool-22 (SNOT-22)
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at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Neurologic Manifestations
- Sensation Disorders
- COVID-19
- Disease
- Anosmia
- Olfaction Disorders
Other Study ID Numbers
- REC Ref: 20/SC/0231
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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