A Simplified Test to Assess Flavor in COVID-19 Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HOS: hospitalized COVID19 patients Patients positive to COVID19 hospitalized |
Diagnostic Test: Flavor test
A simplified self-administrable flavor test has been proposted to all the enrolled subjects
Other: Self-assesment questionnaire
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".
|
| HI: Home-isolated COVID19 patients Home-isolated patients positive to COVID19 |
Diagnostic Test: Flavor test
A simplified self-administrable flavor test has been proposted to all the enrolled subjects
Other: Self-assesment questionnaire
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".
|
| CTRL: Healthy controls Healthy COVID19 negative subjects |
Diagnostic Test: Flavor test
A simplified self-administrable flavor test has been proposted to all the enrolled subjects
|
Outcome Measures
Primary Outcome Measures
- Flavor perception [Apr, 2020- Jan, 2021]
To assess qualitative flavor perception
Secondary Outcome Measures
- Flavor perception intensity [Apr, 2020- Jan, 2021]
To assess quantitative flavor perception
Other Outcome Measures
- Comparison with self-estimated flavor perception [Apr, 2020- Jan, 2021]
To compare results of the test with self-assessed flavor and smell perception
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults (≥18 years of age) that gave their written informed consent to the study
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Diagnosis of COVID-19 was confirmed by PCR of nasopharyngeal swab (HI or HOS)
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Negative COVID-19 nasopharyngeal swab (CTRL)
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Subjects with no critical conditions and able to understand the protocol
Exclusion Criteria:
- nasal obstruction or previous nasal diseases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dipartimento di Medicina Clinica e Chirurgia | Napoli | Italy | 80131 |
Sponsors and Collaborators
- Federico II University
Investigators
- Principal Investigator: Paolo E Macchia, M.D., Ph.D., Federico II University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PM0001/2020