A Simplified Test to Assess Flavor in COVID-19 Patients
Simplified Flavor Test for Self-administation in COVID-19 Positive Patients
1 other identifier
observational
111
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2021
CompletedFirst Submitted
Initial submission to the registry
April 8, 2021
CompletedFirst Posted
Study publicly available on registry
April 12, 2021
CompletedApril 15, 2021
April 1, 2021
9 months
April 8, 2021
April 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Flavor perception
To assess qualitative flavor perception
Apr, 2020- Jan, 2021
Secondary Outcomes (1)
Flavor perception intensity
Apr, 2020- Jan, 2021
Other Outcomes (1)
Comparison with self-estimated flavor perception
Apr, 2020- Jan, 2021
Study Arms (3)
HOS: hospitalized COVID19 patients
Patients positive to COVID19 hospitalized
HI: Home-isolated COVID19 patients
Home-isolated patients positive to COVID19
CTRL: Healthy controls
Healthy COVID19 negative subjects
Interventions
A simplified self-administrable flavor test has been proposted to all the enrolled subjects
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".
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- nasal obstruction or previous nasal diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dipartimento di Medicina Clinica e Chirurgia
Napoli, 80131, Italy
Related Publications (1)
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.
PMID: 34562193DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo E Macchia, M.D., Ph.D.
Federico II University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Md., Ph.D.
Study Record Dates
First Submitted
April 8, 2021
First Posted
April 12, 2021
Study Start
May 5, 2020
Primary Completion
January 15, 2021
Study Completion
January 15, 2021
Last Updated
April 15, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share