TY  - JOUR
AU  - Sheen, Florence
AU  - Tan, Vicki
AU  - Haldar, Sumanto
AU  - Sengupta, Sharmila
AU  - Allen, David
AU  - Somani, Jyoti
AU  - Chen, Hui Yee
AU  - Tambyah, Paul
AU  - Forde, Ciaran G
PY  - 2020
DA  - 2020/12/31
TI  - 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
JO  - JMIR Res Protoc
SP  - e24797
VL  - 9
IS  - 12
KW  - SARS-CoV-2
KW  - COVID-19
KW  - olfactory dysfunction
KW  - gustatory dysfunction
KW  - anosmia
KW  - ageusia
KW  - onset
KW  - severity
KW  - symptom
KW  - infectious disease
KW  - dysfunction
KW  - protocol
KW  - marker
KW  - recovery
KW  - monitoring
KW  - taste
KW  - smell
AB  - 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 
SN  - 1929-0748
UR  - http://www.researchprotocols.org/2020/12/e24797/
UR  - https://doi.org/10.2196/24797
UR  - http://www.ncbi.nlm.nih.gov/pubmed/33351775
DO  - 10.2196/24797
ID  - info:doi/10.2196/24797
ER  -