Clinical Trials Directory

Trials / Completed

CompletedNCT04840966

A Simplified Test to Assess Flavor in COVID-19 Patients

Simplified Flavor Test for Self-administation in COVID-19 Positive Patients

Status
Completed
Phase
Study type
Observational
Enrollment
111 (actual)
Sponsor
Federico II University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTFlavor testA simplified self-administrable flavor test has been proposted to all the enrolled subjects
OTHERSelf-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".

Timeline

Start date
2020-05-05
Primary completion
2021-01-15
Completion
2021-01-15
First posted
2021-04-12
Last updated
2021-04-15

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04840966. Inclusion in this directory is not an endorsement.