Other Clinical Trial - Assessment of Olfactory Dysfunction in SARS CoV-2

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04466982
Study type	Observational
Source	Cambridge University Hospitals NHS Foundation Trust
Contact
Status	Recruiting
Phase
Start date	July 2, 2020
Completion date	January 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Assessment of Olfactory Dysfunction in SARS CoV-2 (COVID-19) Infection — ODYSSI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms