NCT04492904

Brief Summary

The study aims to longitudinally track the onset, severity and recovery of changes in chemosensory acuity (smell and/or taste loss) among those suspected of COVID-19 infection. Using standardised questionnaire and testing approaches, the investigators aim to objectively characterise and measure temporal changes in taste and smell to confirm the prevalence of these symptoms as an early marker of infection. Information on symptoms experience, changes in appetite and food-related quality of life will be also be assessed via questionnaire. The results of the study will help individuals who experience a loss of smell and/or taste to self-isolate and/or self-refer to a medical professional, if an association between smell and/or taste and COVID-19 infection is found.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

11 months

First QC Date

July 27, 2020

Last Update Submit

December 13, 2021

Conditions

Keywords

Olfactory dysfunctionGustatory dysfunctionAnosmiaAgeusiaSARS-CoV-2COVID-19

Outcome Measures

Primary Outcomes (1)

  • Taste and smell acuity

    Taste and smell functions of all participants will be assessed as part of the Home-use Test using taste test items (i.e. sweet: sugar, salty: salt, sour: lime powder and bitter: coffee powder) and odour pens respectively. Participants will identify the taste/smell and rate the perceived intensity on a Visual Analogue Scale (VAS) from 'not strong at all' (0) to 'extremely strong taste/smell' (100). A higher score will indicate greater intensity of taste/smell perceived.

    28 days

Secondary Outcomes (1)

  • Experienced symptoms, changes in appetite and food-related quality of life

    28 days

Study Arms (2)

COVID-19 Positive (Case)

Participants who were present for COVID-19 screening and their test results will later indicate positive of infection. Participants will complete a one-time assessment of the various online questionnaires (Singapore Smell and Test Questionnaire, Sino-nasal Outcome Test-22, and Global Consortium for Chemosensory Research Questionnaire - Optional) in the hospital/clinic. Taste and smell acuity, as well as experienced symptoms, changes in appetite and food-related quality of life will be assessed using the Home-use Tests and Follow-up questionnaire over a period of 28 days.

Other: Home-use Test and Follow-up Questionnaire

COVID-19 Negative/Other respiratory diseases (Control)

Participants who were present for COVID-19 screening and their test results will later indicate negative of infection. Participants will complete a one-time assessment of the various online questionnaires (Singapore Smell and Test Questionnaire, Sino-nasal Outcome Test-22, and Global Consortium for Chemosensory Research Questionnaire - Optional) in the hospital/clinic. Taste and smell acuity, as well as experienced symptoms, changes in appetite and food-related quality of life will be assessed using the Home-use Tests and Follow-up questionnaire over a period of 28 days

Other: Home-use Test and Follow-up Questionnaire

Interventions

Prospective tracking of changes in taste and smell acuity, and related changes in appetite, enjoyment of food and food-related quality of life will be assessed using the Home-use Tests and Follow-up questionnaire over a period of 28 days.

COVID-19 Negative/Other respiratory diseases (Control)COVID-19 Positive (Case)

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients present for COVID 19 screening

You may qualify if:

  • Age 21 years and above
  • Residing in Singapore for the next 28 days.
  • Possess a mobile device with 4G network and knows how to use mobile apps (i.e. QR scanner)

You may not qualify if:

  • Unable to provide informed consent
  • Allergic/ intolerant to test items (i.e. fragrances, sugar, salt, coffee or lime powder)
  • Not agreeable with the study team accessing your medical records
  • For women: Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre, Singapore

Singapore, 117599, Singapore

Location

Related Publications (1)

  • 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 Dec 31;9(12):e24797. doi: 10.2196/24797.

MeSH Terms

Conditions

COVID-19AnosmiaAgeusia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOlfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsTaste Disorders

Study Officials

  • Ciaran Forde, Phd

    Singapore Institute of Food and Biotechnology Innovation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2020

First Posted

July 30, 2020

Study Start

July 17, 2020

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

December 14, 2021

Record last verified: 2021-12

Locations