Covid19NCT04492904
Singapore COVID-19 Chemosensory Tracking (SCCT) Study
An observational study of Covid19, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Covid19
- What is being tested?
- Home-use Test and Follow-up Questionnaire
- How many people
- 102 participants
- Where
- 1 siteSingapore
- Study dates
- 17 Jul 2020to 15 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients present for COVID 19 screening
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Clinical Nutrition Research Centre, Singapore
Singapore, 117599
About this study
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.
Read the detailed description
The study will be a retrospective-prospective, longitudinal case-control observational study using a convenience sample drawn from patients presenting for COVID-19 screening, and will recruit both males and females above the age of 21 years who consent to provide anonymised data online on recent changes to their taste and smell. There will be no intervention (medication or foods) as part of this study. Potential participants will be screened to ensure they meet the study inclusion and exclusion criteria and all participants will sign an informed consent.
During their first recruitment session at the hospital/clinic, participants will be required to complete a series of questionnaires to record recent changes in taste and smell sensitivity. The series of questionnaires will include: Singapore Smell and Taste Questionnaire (SSTQ), Sino-nasal Outcome Test-22 (SNOT-22) and optionally, the Global Consortium of Chemosensory Research Questionnaire (GCCRQ). The purpose of administering the different questionnaires is to cover wide range of complementary questions that capture information related to changes in taste and smell function associated with COVID-19 infection. Thereafter participants will be briefed on how to complete the home-use standardized smell and taste test (Home-use Test). The Home-use Test (HUT) will be completed daily over a 28 day period at participants place of residence, to enable self-monitoring of changes to smell and taste abilities. During the HUT, participants will rate their sense of smell using the two standardised odour pens they are provided on the first day of their session at the hospital/ clinic. For each pen, participants will be asked to identify the odour and rate the perceived intensity. This will then be followed a taste test where participants will take a small quantity of a powder representing each of the four prototypical basic tastes sweet (sugar), salt (table salt), bitter (coffee powder or tea) and sour (lime powder), to the tip end of their tongue with a small spoon to taste. Participant are asked to self-report that they confirm that can identify the taste quality and to rate the perceived intensity on line scales provided in an online questionnaire. All measures are self-administered and completed independently by the participant, with responses captured using unique identifier code for each participant through an online software (CompuSense, Guelph, Ontario). During the 28-day home use test period, once a week participants will be asked to complete a 'Follow-up Questionnaire' which will assess how the symptoms experienced have impacted their enjoyment of food, appetite and food-related quality of life.
- Conditions
- Covid19
- Being tested
- Home-use Test and Follow-up Questionnaire
- Keywords
- Olfactory dysfunction, Gustatory dysfunction, Anosmia, Ageusia, SARS-CoV-2, COVID-19
- Medical subject headings
- COVID-19, Anosmia, Ageusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-use Test and Follow-up QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Home-use Test and Follow-up Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (1)
Experienced symptoms, changes in appetite and food-related quality of life
Experienced symptoms, changes in appetite and food-related quality of life will be assessed as part of the Follow-up questionnaire.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start17 Jul 2020
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Principal investigator, Vicki Tan, Singapore Institute of Food and Biotechnology Innovation
- Investigators
- Ciaran Forde, Phd, Principal investigator, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492904
- Sponsor's protocol ID
- 2020/00810
- Status last verified
- Dec 2021
- First submitted
- 27 Jul 2020
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33351775
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Singapore COVID-19 Chemosensory Tracking (SCCT) Study
- ClinicalTrials.gov ID
- NCT04492904
- Acronym / sponsor ID
- 2020/00810
- Conditions
- Covid19
- Keywords
- Olfactory dysfunction, Gustatory dysfunction, Anosmia, Ageusia, SARS-CoV-2, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Collaborators
- National University Hospital, Singapore
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be a retrospective-prospective, longitudinal case-control observational study using a convenience sample drawn from patients presenting for COVID-19 screening, and will recruit both males and females above the age of 21 years who consent to provide anonymised data online on recent changes to their taste and smell. There will be no intervention (medication or foods) as part of this study. Potential participants will be screened to ensure they meet the study inclusion and exclusion criteria and all participants will sign an informed consent.
During their first recruitment session at the hospital/clinic, participants will be required to complete a series of questionnaires to record recent changes in taste and smell sensitivity. The series of questionnaires will include: Singapore Smell and Taste Questionnaire (SSTQ), Sino-nasal Outcome Test-22 (SNOT-22) and optionally, the Global Consortium of Chemosensory Research Questionnaire (GCCRQ). The purpose of administering the different questionnaires is to cover wide range of complementary questions that capture information related to changes in taste and smell function associated with COVID-19 infection. Thereafter participants will be briefed on how to complete the home-use standardized smell and taste test (Home-use Test). The Home-use Test (HUT) will be completed daily over a 28 day period at participants place of residence, to enable self-monitoring of changes to smell and taste abilities. During the HUT, participants will rate their sense of smell using the two standardised odour pens they are provided on the first day of their session at the hospital/ clinic. For each pen, participants will be asked to identify the odour and rate the perceived intensity. This will then be followed a taste test where participants will take a small quantity of a powder representing each of the four prototypical basic tastes sweet (sugar), salt (table salt), bitter (coffee powder or tea) and sour (lime powder), to the tip end of their tongue with a small spoon to taste. Participant are asked to self-report that they confirm that can identify the taste quality and to rate the perceived intensity on line scales provided in an online questionnaire. All measures are self-administered and completed independently by the participant, with responses captured using unique identifier code for each participant through an online software (CompuSense, Guelph, Ontario). During the 28-day home use test period, once a week participants will be asked to complete a 'Follow-up Questionnaire' which will assess how the symptoms experienced have impacted their enjoyment of food, appetite and food-related quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Positive (Case) | – | Other: Home-use Test and Follow-up QuestionnaireParticipants 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. |
| COVID-19 Negative/Other respiratory diseases (Control) | – | Other: Home-use Test and Follow-up QuestionnaireParticipants 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 |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients present for COVID 19 screening
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-use Test and Follow-up QuestionnaireProspective 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. | Other | COVID-19 Negative/Other respiratory diseases (Control), COVID-19 Positive (Case) |
Primary outcome
Taste and smell acuity
Time frame: 28 days
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.
1 secondary outcome
Experienced symptoms, changes in appetite and food-related quality of life
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Derived from this study: PubMed 33351775Sheen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ciaran Forde, Phd principal investigator
Singapore Institute of Food and Biotechnology Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste and smell acuity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04492904, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.