@Article{info:doi/10.2196/24797,
author="Sheen, Florence
and Tan, Vicki
and Haldar, Sumanto
and Sengupta, Sharmila
and Allen, David
and Somani, Jyoti
and Chen, Hui Yee
and Tambyah, Paul
and Forde, Ciaran G",
title="Evaluating the Onset, Severity, and Recovery of Changes to Smell and Taste Associated With COVID-19 Infection in a Singaporean Population (the COVOSMIA-19 Trial): Protocol for a Prospective Case-Control Study",
journal="JMIR Res Protoc",
year="2020",
month="Dec",
day="31",
volume="9",
number="12",
pages="e24797",
keywords="SARS-CoV-2; COVID-19; olfactory dysfunction; gustatory dysfunction; anosmia; ageusia; onset; severity; symptom; infectious disease; dysfunction; protocol; marker; recovery; monitoring; taste; smell",
abstract="Background: Sudden loss of smell and/or taste has been suggested to be an early marker of COVID-19 infection, with most findings based on self-reporting of sensory changes at a single time point. Objective: To understand the onset, severity, and recovery of sensory changes associated with COVID-19 infection, this study will longitudinally track changes in chemosensory acuity among people with suspected COVID-19 infection using standardized 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 by respiratory tract polymerase chain reaction test (``swab test''). The volunteers 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 daily self-assessments of their smell and taste acuity at their place of residence for up to 4 weeks, with all data submitted for collection through web-based 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 July 23, 2020, and will continue through to March 31, 2021. As of October 2, 2020, 69 participants had 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 by PCR swab test, in a population-based cohort. The 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 patients with COVID-19. This self-administered and cost-effective approach has many advantages over self-report questionnaire--based methods and provides a more objective measure of smell and taste changes associated with COVID-19 infection; this 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 control the COVID-19 pandemic and reduce the emergence of clusters of infections. Trial Registration: ClinicalTrials.gov NCT04492904; https://clinicaltrials.gov/ct2/show/NCT04492904. International Registered Report Identifier (IRRID): DERR1-10.2196/24797 ",
issn="1929-0748",
doi="10.2196/24797",
url="http://www.researchprotocols.org/2020/12/e24797/",
url="https://doi.org/10.2196/24797",
url="http://www.ncbi.nlm.nih.gov/pubmed/33351775"
}