Assessment of Olfactory Dysfunction in SARS CoV-2 (COVID-19) Infection (ODYSSI)
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|ClinicalTrials.gov Identifier: NCT04466982|
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : December 14, 2020
|Condition or disease|
|Olfactory Disorder COVID19 SARS-CoV-2 Anosmia Microsomia Smell Disorder Quality of Life|
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 :||Observational|
|Estimated Enrollment :||90 participants|
|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|
|Actual Study Start Date :||July 2, 2020|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||January 2022|
- 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
- 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.
- 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)
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466982
|Cambridge, United Kingdom, CB2 0QQ|
|Contact: Rachel Kyd, FRCS (ORL-HNS) 01223 245151 Rachel.Kyd@addenbrookes.nhs.uk|
|Principal Investigator: Ekpemi Irune, FRCS (ORL-HNS)|
|Sub-Investigator: Rishi Sharma, FRCS (ORL-HNS)|
|Sub-Investigator: Kristian Hutson, FRCS (ORL-HNS)|
|Charing Cross Hospital||Recruiting|
|London, United Kingdom, W6 8RF|
|Contact: Omolade Awomolo 020 3313 7306 Omolade.Awomolo@nhs.net|
|Principal Investigator: Catherine Rennie, FRCS (ORL-HNS)|
|Sub-Investigator: Hesham Saleh, FRCS (ORL-HNS)|
|Royal Cornwall Hospital||Recruiting|
|Truro, United Kingdom, TR1 3LQ|
|Contact: Gina Townley 01872 256429 email@example.com|
|Principal Investigator: Neil Tan, FRCS (ORL-HNS)|