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OpenTrials
Completed

NCT Number: NCT04840966

A Simplified Test to Assess Flavor in COVID-19 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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flavor test

Diagnostic Test

A simplified self-administrable flavor test has been proposted to all the enrolled subjects

Self-assesment questionnaire

Other

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".

Primary outcomes

  1. Flavor perception

    Time frame: Apr, 2020- Jan, 2021

    To assess qualitative flavor perception

Secondary outcomes

  1. Flavor perception intensity

    Time frame: Apr, 2020- Jan, 2021

    To assess quantitative flavor perception

Other outcomes

  1. Comparison with self-estimated flavor perception

    Time frame: Apr, 2020- Jan, 2021

    To compare results of the test with self-assessed flavor and smell perception

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2021
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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