Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-02 @ 9:09 AM
Study NCT ID:
NCT04354857
Status:
COMPLETED
Last Update Posted:
2021-06-21
First Post:
2020-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Qualitative and Quantitative Evaluation of Anosmia Over Time in Clinically Symptomatic Patients Tested for COVID-19 Infection
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012903', 'term': 'Smell'}], 'ancestors': [{'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 454}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-18', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS-CoV-2 infection status', 'timeFrame': 'Day 0', 'description': 'Positive/negative according to RT-PCR assay'}, {'measure': 'Olfactory and gustatory loss', 'timeFrame': 'Day 0', 'description': 'Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)'}], 'secondaryOutcomes': [{'measure': 'Ability to detect odor', 'timeFrame': 'Day 0', 'description': 'Ability to smell 1.5ml air freshner on a 0-100 VAS scale'}, {'measure': 'Ability to detect odor', 'timeFrame': 'Six months', 'description': 'Ability to smell 1.5ml air freshner on a 0-100 VAS scale'}, {'measure': 'Ability to detect salty taste', 'timeFrame': 'Day 0', 'description': 'Ability to taste a pinch of table salt on a 0-100 VAS scale'}, {'measure': 'Ability to detect salty taste', 'timeFrame': 'Six months', 'description': 'Ability to taste a pinch of table salt on a 0-100 VAS scale'}, {'measure': 'Ability to detect sweet taste', 'timeFrame': 'Day 0', 'description': 'Ability to taste a pinch of sugar on a 0-100 VAS scale'}, {'measure': 'Ability to detect sweet taste', 'timeFrame': 'Six months', 'description': 'Ability to taste a pinch of sugar on a 0-100 VAS scale'}, {'measure': 'Olfactory and gustatory loss', 'timeFrame': 'Day 7', 'description': 'Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)'}, {'measure': 'Olfactory and gustatory loss', 'timeFrame': 'Day 14', 'description': 'Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)'}, {'measure': 'Olfactory and gustatory loss', 'timeFrame': 'Day 30', 'description': 'Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)'}, {'measure': 'Olfactory and gustatory loss', 'timeFrame': 'Day 60', 'description': 'Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)'}, {'measure': 'Severity of infection according to hospitalization rate', 'timeFrame': 'End of study (six months)', 'description': '% patients hospitalized'}, {'measure': 'Olfactory and gustatory loss', 'timeFrame': 'Six months', 'description': 'Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anosmia', 'SARS-Cov-2'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Loss of sense of smell and taste has been anecdotally reported during the covid-19 epidemic. The study investigators wanted to describe the prevalence of olfactory and gustatory dysfunction and assess the factors associated with positive SARS-CoV-2 infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adults referred for a suspicion of COVID-19 infection and tested by RT-PCR assay for detection of SARS-CoV-2 in a nasopharyngeal sample at the COVID Screening Center or in the infectious and tropical diseases department of the University Hospital of Nîmes,', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting with COVID-19 related symptoms including: fever, persistent cough, fatigue, shortness of breath, diarrhoea, abdominal pain, chest pain, sore throat, loss of smell or taste\n* Subjects in prolonged contact with COVID-19 infected patients.\n\nExclusion Criteria:\n\n* Patients directly admitted to the intensive care unit were excluded\n* Patients opposing use of their health data'}, 'identificationModule': {'nctId': 'NCT04354857', 'acronym': 'Anosmie-COVID', 'briefTitle': 'Qualitative and Quantitative Evaluation of Anosmia Over Time in Clinically Symptomatic Patients Tested for COVID-19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Qualitative and Quantitative Evaluation of Anosmia Over Time in Clinically Symptomatic Patients Tested for COVID-19 Infection', 'orgStudyIdInfo': {'id': 'IRB: 20.04.09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RT-PCR SARS-CoV-2 positive', 'interventionNames': ['Other: olfactory and gustatory tests']}, {'label': 'RT-PCR SARS-CoV-2 negative', 'interventionNames': ['Other: olfactory and gustatory tests']}], 'interventions': [{'name': 'olfactory and gustatory tests', 'type': 'OTHER', 'description': 'Participants rate quality of sense of smell and taste.\n\nOlfaction test: Sniff 10ml test tube containing 1.5ml air freshner (Mifleur Citron, Coldis, Entraigues sur Sorgues, France) and rate perception of odor.\n\nGustatory test: Taste a pinch and sugar and salt and rate perception of sweet or salty taste', 'armGroupLabels': ['RT-PCR SARS-CoV-2 negative', 'RT-PCR SARS-CoV-2 positive']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Benjamin Lallemant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nimes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}