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
©Florence Sheen, Vicki Tan, Sumanto Haldar, Sharmila Sengupta, David Allen, Jyoti Somani, Hui Yee Chen, Paul Tambyah, Ciaran G Forde. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 31.12.2020..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:9 |
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| Enthalten in: |
JMIR research protocols - 9(2020), 12 vom: 31. Dez., Seite e24797 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Sheen, Florence [VerfasserIn] |
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| Links: |
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| Themen: |
Ageusia |
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| Anmerkungen: |
Date Revised 11.01.2021 published: Electronic ClinicalTrials.gov: NCT04492904 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.2196/24797 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM319163059 |
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| 245 | 1 | 0 | |a 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) |b Protocol for a Prospective Case-Control Study |
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| 500 | |a Date Revised 11.01.2021 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04492904 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a ©Florence Sheen, Vicki Tan, Sumanto Haldar, Sharmila Sengupta, David Allen, Jyoti Somani, Hui Yee Chen, Paul Tambyah, Ciaran G Forde. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 31.12.2020. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov NCT04492904; https://clinicaltrials.gov/ct2/show/NCT04492904 | ||
| 520 | |a INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24797 | ||
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| 700 | 1 | |a Haldar, Sumanto |e verfasserin |4 aut | |
| 700 | 1 | |a Sengupta, Sharmila |e verfasserin |4 aut | |
| 700 | 1 | |a Allen, David |e verfasserin |4 aut | |
| 700 | 1 | |a Somani, Jyoti |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Hui Yee |e verfasserin |4 aut | |
| 700 | 1 | |a Tambyah, Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Forde, Ciaran G |e verfasserin |4 aut | |
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