A Simplified Test to Assess Flavor in COVID-19 Patients

NCT ID: NCT04840966

Last Updated: 2021-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-05

Study Completion Date

2021-01-15

Brief Summary

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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

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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

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HOS: hospitalized COVID19 patients

Patients positive to COVID19 hospitalized

Flavor test

Intervention Type DIAGNOSTIC_TEST

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

Self-assesment questionnaire

Intervention Type 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".

HI: Home-isolated COVID19 patients

Home-isolated patients positive to COVID19

Flavor test

Intervention Type DIAGNOSTIC_TEST

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

Self-assesment questionnaire

Intervention Type 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".

CTRL: Healthy controls

Healthy COVID19 negative subjects

Flavor test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Flavor test

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

Intervention Type DIAGNOSTIC_TEST

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".

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Paolo Emidio Macchia

Md., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paolo E Macchia, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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Dipartimento di Medicina Clinica e Chirurgia

Napoli, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 34562193 (View on PubMed)

Other Identifiers

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PM0001/2020

Identifier Type: -

Identifier Source: org_study_id

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