Covid19NCT04840966
A Simplified Test to Assess Flavor in COVID-19 Patients
An observational study of Covid19, run by Federico II University at 1 site in Italy.
Trial summary
The Flavor test has been developed and validated by our group to assess retro-nasal olfactory performances. The original flavor test has been simplified, with the great advantage to be self-administrable for COVID-19 patients in isolation, without any risk to health professionals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Flavor test and Self-assesment questionnaire
- How many people
- 111 participants
- Where
- 1 siteItaly
- Study dates
- 5 May 2020to 15 Jan 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 18 years and older
- All sexes
- Adult, Older adult
Study population: A total of 111 subjects (19 hospitalized [HOS] and 37 home-isolated [HI] COVID-19 patients, and 55 healthy controls [CTRL]) were enrolled in the study. The mean age for overall population was 41.52±14.45 years.
Who may be able to join
- Adults (≥18 years of age) that gave their written informed consent to the study
- Diagnosis of COVID-19 was confirmed by PCR of nasopharyngeal swab (HI or HOS)
- Negative COVID-19 nasopharyngeal swab (CTRL)
- Subjects with no critical conditions and able to understand the protocol
Who cannot join
- nasal obstruction or previous nasal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simplified Flavor Test for Self-administation in COVID-19 Positive Patients
The Flavor test has been developed and validated by our group to assess retro-nasal olfactory performances.
The original flavor test has been simplified, with the great advantage to be self-administrable for COVID-19 patients in isolation, without any risk to health professionals.
Read the detailed description
Smell and taste dysfunctions (STDs) are symptoms associated with COVID-19 syndrome, even if their incidence is still uncertain and variable. In this study, the effects of SARS-CoV-2 infection on chemosensory function have been investigated using both a self-reporting questionnaire on smell and flavor perception, and a simplified flavor test. A total of 111 subjects (19 hospitalized [HOS] and 37 home-isolated [HI] COVID-19 patients, and 55 healthy controls [CTRL]) were enrolled in the study. The flavor test used consists in the self-administration of four solution with a pure olfactory stimulus (coffee), a mixed olfactory-trigeminal stimulus (peppermint), and a complex chemical mixture (banana).
After SARS-CoV-2 infection, HOS and HI patients reported similar frequency of STDs, with a significant reduction of both smell and flavor self-estimated perception.
The aromas of the Flavor test were recognized by HI and HOS COVID-19 patients similarly to CTRL, however the intensity of the perceived aromas was significantly lower in patients compared to controls.
This suggests that a chemosensory impairment is present after SARS-CoV-2 infection, and the modified "flavor test" could be a novel self-administering objective screening test to assess STDs in COVID-19 patients.
- Conditions
- Covid19
- Being tested
- Flavor test, Self-assesment questionnaire
- Keywords
- flavor, smell, flavor test, hyposmia, retro-nasal olfaction
- Medical subject headings
- COVID-19, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavor testDiagnostic test
A simplified self-administrable flavor test has been proposted to all the enrolled subjects
Self-assesment questionnaireOther
Questionnaire to score subjective chemosensory function (smell and flavor) before and after COVID-19 using a 0-10 scale with 0 corresponding to "no smell/flavor perception" and 10 corresponding to "excellent smell/flavor perception".
| Study group | Role | What they receive |
|---|---|---|
| HOS: hospitalized COVID19 patients | Patients positive to COVID19 hospitalized Receives: Diagnostic Test: Flavor test; Other: Self-assesment questionnaire | |
| HI: Home-isolated COVID19 patients | Home-isolated patients positive to COVID19 Receives: Diagnostic Test: Flavor test; Other: Self-assesment questionnaire | |
| CTRL: Healthy controls | Healthy COVID19 negative subjects Receives: Diagnostic Test: Flavor test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flavor perception
To assess qualitative flavor perception
Measured: Apr, 2020- Jan, 2021
Secondary outcomes (1)
Flavor perception intensity
To assess quantitative flavor perception
Measured: Apr, 2020- Jan, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start5 May 2020
- Primary completion15 Jan 2021
- Study completion15 Jan 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.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Emidio Macchia, Federico II University
- Investigators
- Paolo E Macchia, M.D., Ph.D., Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840966
- Sponsor's protocol ID
- PM0001/2020
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nettore IC, Cantone E, Palatucci G, Franchini F, Maturi R, Nerilli M, Manzillo E, Foggia M, Maione L, Ungaro P, Colao A, Macchia PE. Quantitative but not qualitative flavor recognition impairments in COVID-19 patients. Ir J Med Sci. 2022 Aug;191(4):1759-1766. doi: 10.1007/s11845-021-02786-x. Epub 2021 Sep 25.
PubMed 34562193
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified Flavor Test for Self-administation in COVID-19 Positive Patients
- ClinicalTrials.gov ID
- NCT04840966
- Acronym / sponsor ID
- PM0001/2020
- Conditions
- Covid19
- Keywords
- flavor, smell, flavor test, hyposmia, retro-nasal olfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 12 Apr 2021 (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 Flavor test has been developed and validated by our group to assess retro-nasal olfactory performances.
The original flavor test has been simplified, with the great advantage to be self-administrable for COVID-19 patients in isolation, without any risk to health professionals.
Detailed description
Smell and taste dysfunctions (STDs) are symptoms associated with COVID-19 syndrome, even if their incidence is still uncertain and variable. In this study, the effects of SARS-CoV-2 infection on chemosensory function have been investigated using both a self-reporting questionnaire on smell and flavor perception, and a simplified flavor test. A total of 111 subjects (19 hospitalized [HOS] and 37 home-isolated [HI] COVID-19 patients, and 55 healthy controls [CTRL]) were enrolled in the study. The flavor test used consists in the self-administration of four solution with a pure olfactory stimulus (coffee), a mixed olfactory-trigeminal stimulus (peppermint), and a complex chemical mixture (banana).
After SARS-CoV-2 infection, HOS and HI patients reported similar frequency of STDs, with a significant reduction of both smell and flavor self-estimated perception.
The aromas of the Flavor test were recognized by HI and HOS COVID-19 patients similarly to CTRL, however the intensity of the perceived aromas was significantly lower in patients compared to controls.
This suggests that a chemosensory impairment is present after SARS-CoV-2 infection, and the modified "flavor test" could be a novel self-administering objective screening test to assess STDs in COVID-19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HOS: hospitalized COVID19 patients | – | Diagnostic Test: Flavor test, Other: Self-assesment questionnairePatients positive to COVID19 hospitalized |
| HI: Home-isolated COVID19 patients | – | Diagnostic Test: Flavor test, Other: Self-assesment questionnaireHome-isolated patients positive to COVID19 |
| CTRL: Healthy controls | – | Diagnostic Test: Flavor testHealthy COVID19 negative subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 111 subjects (19 hospitalized [HOS] and 37 home-isolated [HI] COVID-19 patients, and 55 healthy controls [CTRL]) were enrolled in the study. The mean age for overall population was 41.52±14.45 years.
Key inclusion criteria (4 listed)
- Adults (≥18 years of age) that gave their written informed consent to the study
- Diagnosis of COVID-19 was confirmed by PCR of nasopharyngeal swab (HI or HOS)
- Negative COVID-19 nasopharyngeal swab (CTRL)
- Subjects with no critical conditions and able to understand the protocol
Key exclusion criteria (1 listed)
- nasal obstruction or previous nasal diseases
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 |
|---|---|---|
| Flavor testA simplified self-administrable flavor test has been proposted to all the enrolled subjects | Diagnostic test | CTRL: Healthy controls, HI: Home-isolated COVID19 patients, HOS: hospitalized COVID19 patients |
| Self-assesment questionnaireQuestionnaire to score subjective chemosensory function (smell and flavor) before and after COVID-19 using a 0-10 scale with 0 corresponding to "no smell/flavor perception" and 10 corresponding to "excellent smell/flavor perception". | Other | HI: Home-isolated COVID19 patients, HOS: hospitalized COVID19 patients |
Primary outcome
Flavor perception
Time frame: Apr, 2020- Jan, 2021
To assess qualitative flavor perception
1 secondary outcome
Flavor perception intensity
Time frame: Apr, 2020- Jan, 2021
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 15 Apr 2021.
- Derived from this study: PubMed 34562193Nettore IC, Cantone E, Palatucci G, Franchini F, Maturi R, Nerilli M, Manzillo E, Foggia M, Maione L, Ungaro P, Colao A, Macchia PE. Quantitative but not qualitative flavor recognition impairments in COVID-19 patients. Ir J Med Sci. 2022 Aug;191(4):1759-1766. doi: 10.1007/s11845-021-02786-x. Epub 2021 Sep 25.
- Individual participant dataSharing planned: No
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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.
Paolo E Macchia, M.D., Ph.D. principal investigator
Federico II University
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 Federico II University at 1 site in Italy.
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 4 inclusion and 1 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 15 Apr 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 Italy. 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?
Flavor perception (time frame: Apr, 2020- Jan, 2021). 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 NCT04840966, 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 15 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.