A Simplified Test to Assess Flavor in COVID-19 Patients
NCT ID: NCT04840966
Last Updated: 2021-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
111 participants
OBSERVATIONAL
2020-05-05
2021-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Smell and Taste Disorders in COVID-19 Patients
NCT04427332
Qualitative and Quantitative Evaluation of Anosmia Over Time in Clinically Symptomatic Patients Tested for COVID-19 Infection
NCT04354857
Frequency and Clinical Evolution of Olfactory and Taste Disorders in COVID-19 Patients
NCT04361565
Oral and Olfactory Complications of Recovered COVID-19 Patients
NCT04791436
EFFECT OF COVID-19 DISEASE IN SMELL AND TASTE OF PATIENTS WITH MILD, MODERATE OR SEVERE SYMPTOMATOLOGY
NCT04657445
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HOS: hospitalized COVID19 patients
Patients positive to COVID19 hospitalized
Flavor test
A simplified self-administrable flavor test has been proposted to all the enrolled subjects
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".
HI: Home-isolated COVID19 patients
Home-isolated patients positive to COVID19
Flavor test
A simplified self-administrable flavor test has been proposted to all the enrolled subjects
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".
CTRL: Healthy controls
Healthy COVID19 negative subjects
Flavor test
A simplified self-administrable flavor test has been proposted to all the enrolled subjects
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Flavor test
A simplified self-administrable flavor test has been proposted to all the enrolled subjects
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".
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federico II University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Paolo Emidio Macchia
Md., Ph.D.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paolo E Macchia, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Federico II University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dipartimento di Medicina Clinica e Chirurgia
Napoli, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PM0001/2020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.