A Simplified Test to Assess Flavor in COVID-19 Patients

Study Overview
=================
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.

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

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Flavor test
* Other: Self-assesment questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HOS: hospitalized COVID19 patients<br>Patients positive to COVID19 hospitalized | Diagnostic Test: Flavor test<br>* A simplified self-administrable flavor test has been proposted to all the enrolled subjects<br>Other: Self-assesment questionnaire<br>* 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.<br>|
| HI: Home-isolated COVID19 patients<br>Home-isolated patients positive to COVID19 | Diagnostic Test: Flavor test<br>* A simplified self-administrable flavor test has been proposted to all the enrolled subjects<br>Other: Self-assesment questionnaire<br>* 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.<br>|
| CTRL: Healthy controls<br>Healthy COVID19 negative subjects | Diagnostic Test: Flavor test<br>* A simplified self-administrable flavor test has been proposted to all the enrolled subjects<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flavor perception | To assess qualitative flavor perception | Apr, 2020- Jan, 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flavor perception intensity | To assess quantitative flavor perception | Apr, 2020- Jan, 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
flavor, smell, flavor test, hyposmia, retro-nasal olfaction