Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT04840966
Status:
COMPLETED
Last Update Posted:
2021-04-15
First Post:
2021-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Simplified Test to Assess Flavor in COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000086582', 'term': 'Anosmia'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000857', 'term': 'Olfaction Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2021-04-08', 'studyFirstSubmitQcDate': '2021-04-08', 'lastUpdatePostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison with self-estimated flavor perception', 'timeFrame': 'Apr, 2020- Jan, 2021', 'description': 'To compare results of the test with self-assessed flavor and smell perception'}], 'primaryOutcomes': [{'measure': 'Flavor perception', 'timeFrame': 'Apr, 2020- Jan, 2021', 'description': 'To assess qualitative flavor perception'}], 'secondaryOutcomes': [{'measure': 'Flavor perception intensity', 'timeFrame': 'Apr, 2020- Jan, 2021', 'description': 'To assess quantitative flavor perception'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['flavor', 'smell', 'flavor test', 'hyposmia', 'retro-nasal olfaction'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '34562193', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The Flavor test has been developed and validated by our group to assess retro-nasal olfactory performances.\n\nThe 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.', 'detailedDescription': '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).\n\nAfter 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.\n\nThe 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥18 years of age) that gave their written informed consent to the study\n* Diagnosis of COVID-19 was confirmed by PCR of nasopharyngeal swab (HI or HOS)\n* Negative COVID-19 nasopharyngeal swab (CTRL)\n* Subjects with no critical conditions and able to understand the protocol\n\nExclusion Criteria:\n\n* nasal obstruction or previous nasal diseases'}, 'identificationModule': {'nctId': 'NCT04840966', 'briefTitle': 'A Simplified Test to Assess Flavor in COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Simplified Flavor Test for Self-administation in COVID-19 Positive Patients', 'orgStudyIdInfo': {'id': 'PM0001/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HOS: hospitalized COVID19 patients', 'description': 'Patients positive to COVID19 hospitalized', 'interventionNames': ['Diagnostic Test: Flavor test', 'Other: Self-assesment questionnaire']}, {'label': 'HI: Home-isolated COVID19 patients', 'description': 'Home-isolated patients positive to COVID19', 'interventionNames': ['Diagnostic Test: Flavor test', 'Other: Self-assesment questionnaire']}, {'label': 'CTRL: Healthy controls', 'description': 'Healthy COVID19 negative subjects', 'interventionNames': ['Diagnostic Test: Flavor test']}], 'interventions': [{'name': 'Flavor test', 'type': 'DIAGNOSTIC_TEST', 'description': 'A simplified self-administrable flavor test has been proposted to all the enrolled subjects', 'armGroupLabels': ['CTRL: Healthy controls', 'HI: Home-isolated COVID19 patients', 'HOS: hospitalized COVID19 patients']}, {'name': 'Self-assesment questionnaire', 'type': 'OTHER', 'description': '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".', 'armGroupLabels': ['HI: Home-isolated COVID19 patients', 'HOS: hospitalized COVID19 patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Dipartimento di Medicina Clinica e Chirurgia', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'overallOfficials': [{'name': 'Paolo E Macchia, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md., Ph.D.', 'investigatorFullName': 'Paolo Emidio Macchia', 'investigatorAffiliation': 'Federico II University'}}}}