A Simplified Test to Assess Flavor in COVID-19 Patients

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: Flavor test; Other: Self-assesment questionnaire

• Registration Number: NCT04840966
• Lead Sponsor: Federico II University

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.

Study Timeline

• Study Start: 2020-05-05
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Status Verified: 2021-04
• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-12
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HOS: hospitalized COVID19 patients	Flavor test	Patients positive to COVID19 hospitalized
HOS: hospitalized COVID19 patients	Self-assesment questionnaire	Patients positive to COVID19 hospitalized
HI: Home-isolated COVID19 patients	Self-assesment questionnaire	Home-isolated patients positive to COVID19
CTRL: Healthy controls	Flavor test	Healthy COVID19 negative subjects
HI: Home-isolated COVID19 patients	Flavor test	Home-isolated patients positive to COVID19

Primary Outcome Measures

Name	Time	Method
Flavor perception	Apr, 2020- Jan, 2021	To assess qualitative flavor perception

Secondary Outcome Measures

Name	Time	Method
Flavor perception intensity	Apr, 2020- Jan, 2021	To assess quantitative flavor perception

Trial Locations

Locations (1)

Dipartimento di Medicina Clinica e Chirurgia; 🇮🇹 Napoli, Italy