A Simplified Test to Assess Flavor in COVID-19 Patients

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Flavor test; Other: Self-assesment questionnaire

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 Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Dipartimento di Medicina Clinica e Chirurgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flavor perception	To assess qualitative flavor perception	Apr, 2020- Jan, 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flavor perception intensity	To assess quantitative flavor perception	Apr, 2020- Jan, 2021

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison with self-estimated flavor perception	To compare results of the test with self-assessed flavor and smell perception	Apr, 2020- Jan, 2021

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Paolo E Macchia, M.D., Ph.D., Federico II University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2020
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: hyposmia; smell; flavor; flavor test; retro-nasal olfaction
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PM0001/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No