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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Oct 6, 2020
Date Accepted: Nov 17, 2020
Date Submitted to PubMed: Dec 22, 2020

The final, peer-reviewed published version of this preprint can be found here:

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

Sheen F, Tan V, Haldar S, Sengupta S, Allen D, Somani J, Chen HY, Tambyah P, Forde CG

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

JMIR Res Protoc 2020;9(12):e24797

DOI: 10.2196/24797

PMID: 33351775

PMCID: 7781589

Warning: This is an author submission that is not peer-reviewed or edited.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)

  • Florence Sheen; 
  • Vicki Tan; 
  • Sumanto Haldar; 
  • Sharmila Sengupta; 
  • David Allen; 
  • Jyoti Somani; 
  • Hui Yee Chen; 
  • Paul Tambyah; 
  • Ciaran G. Forde

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.


 Citation

Please cite as:

Sheen F, Tan V, Haldar S, Sengupta S, Allen D, Somani J, Chen HY, Tambyah P, Forde CG

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

JMIR Res Protoc 2020;9(12):e24797

DOI: 10.2196/24797

PMID: 33351775

PMCID: 7781589

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