Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 6, 2020
Date Accepted: Nov 17, 2020
Date Submitted to PubMed: Dec 22, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Evaluating the Onset, Severity and Recovery from Smell and Taste Changes Associated with COVID-19 Infection in a Singaporean population; A Prospective Case Controlled Study (The COV-OSMIA-19 Trial)
ABSTRACT
Background:
Sudden smell and/or taste loss has been suggested to be an early marker of COVID-19 infection, with most findings based on self-report of sensory changes at a single time-point.
Objective:
To understand the onset, severity, and recovery of sensory changes with COVID-19 infection, this study will longitudinally track changes in chemosensory acuity among those suspected of COVID-19 infection, using standardised test stimuli that are self-administered over 28-days.
Methods:
In a prospective, case-controlled observational study, volunteers will be recruited when they present for COVID-19 screening (respiratory tract PCR; hereafter, swab test) and will initially complete a series of questionnaires to record their recent changes in smell and taste ability, followed by a brief standardized smell and taste test. Participants will receive a home-use smell and taste test kit to prospectively complete a daily self-assessment of their smell and taste acuity at their place of residence for up to 4-weeks, with all data collection submitted through online software.
Results:
This study has been approved by the Domain Specific Review Board of the National Healthcare Group, Singapore, and is funded by the Biomedical Research Council Singapore COVID-19 Research Fund. Recruitment began on 23rd July 2020 and will continue through to 31st March 2021. As of 2nd October 2020, 69 participants have been recruited.
Conclusions:
To our knowledge, this study will be the first to collect longitudinal data on changes to smell and taste sensitivity related to clinically diagnosed COVID-19 infection, confirmed using PCR-swab test, in a population-based cohort. Findings will provide temporal insights on the onset, severity, and recovery of sensory changes with COVID-19 infection, the consistency of symptoms, and the frequency of full smell recovery among COVID-19 patients. This self-administered and cost-effective approach has many advantages over self-report questionnaire-based methods and provides a more objective measure of smell/taste changes associated with COVID-19 infection, and will encourage otherwise asymptomatic individuals who are potential spreaders of the virus to self-isolate and seek formal medical diagnosis if they experience a sudden change in sensory acuity. This broadened case finding can potentially help to control the pandemic and reduce the emergence of clusters of infections. Clinical Trial: ClinicalTrials.gov NCT04492904. Registered on 27 July 2020, Retrospectively registered, version 1, https://clinicaltrials.gov/ct2/show/NCT04492904.
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