Clinical trial NCT04840966: A Simplified Test to Assess Flavor in COVID-19 Patients
Official title: Simplified Flavor Test for Self-administation in COVID-19 Positive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: flavor
smell
flavor test
hyposmia
retro-nasal olfaction
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* nasal obstruction or previous nasal diseases

Primary outcomes:
measure: Flavor perception
timeFrame: Apr, 2020- Jan, 2021
Secondary outcomes:
measure: Flavor perception intensity
timeFrame: Apr, 2020- Jan, 2021
Other outcomes:
measure: Comparison with self-estimated flavor perception
timeFrame: Apr, 2020- Jan, 2021
Locations:
city: Napoli
country: Italy
facility: Dipartimento di Medicina Clinica e Chirurgia
Study officials:
affiliation: Federico II University
name: Paolo E Macchia, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.