Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-29 @ 12:10 PM
Study NCT ID:
NCT04407494
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2020-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders (COVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D000086582', 'term': 'Anosmia'}, {'id': 'D000370', 'term': 'Ageusia'}, {'id': 'D000857', 'term': 'Olfaction Disorders'}, {'id': 'D013651', 'term': 'Taste Disorders'}], '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': 'D007154', 'term': 'Immune System Diseases'}, {'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': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'NC'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 809}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic values of anosmia and ageusia for COVID-19', 'timeFrame': 'at inclusion', 'description': 'Diagnostic values of anosmia and ageusia for COVID-19 with questionnaire'}], 'secondaryOutcomes': [{'measure': 'Diagnostic values of CODA', 'timeFrame': 'at inclusion', 'description': 'Diagnostic values of CODA (Clinical Olfactory dysfunction Assessment) score for COVID-19 : Simple, fast, semi-objective olfactory test developed for epidemic context'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'COVID-19', 'Diagnostic value', 'Sensitivity', 'Specificity', 'Prevalence', 'Positive predictive value', 'Negative predictive value', 'Epidemiology', 'Diagnostic test', 'Anosmia', 'Ageusia', 'Olfactory disorders', 'Gustatory disorders', 'Smell disorders', 'Taste disorders'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Participants are healthcare workers and adult outpatients referred in a COVID-19 screening center. Patients-reported symptoms are collected, then participants underwent a simple olfactory test (CODA for Clinical Olfactory Dysfunction Assessment), prior to swabbing for SARS-CoV-2 diagnosis (RT-PCR). We aimed to evaluate the prevalence of smell and taste disorders, and to calculate the diagnostic value of patient-reported and clinically verified smell disorders in persons with suspected COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthcare workers and adult outpatients attending the COVID-19 screening center of the University Hospital of Montpellier, France.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Symptoms compatible with COVID-19\n* Close exposure to a confirmed COVID-19 index case\n* Ambulatory (asymptomatic, or if symptomatic, did not require hospitalisation, thus with initial mild disease)\n\nExclusion criteria:\n\n* known history of smell and taste disorders\n* testing inability (cognitive impairment, non native French speakers, test malingering)\n* testing contraindication (children, pregnancy, breastfeeding, specific allergies).'}, 'identificationModule': {'nctId': 'NCT04407494', 'acronym': 'COVID-OLFA', 'briefTitle': 'Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders (COVID-19)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders in a Population Tested for COVID-19', 'orgStudyIdInfo': {'id': 'RECHMPL20_0176'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19', 'description': 'Healthcare workers and adult outpatients attending the COVID-19 screening center of the University Hospital of Montpellier, France.', 'interventionNames': ['Biological: Reporting of anosmia, ageusia and other clinical symptoms']}], 'interventions': [{'name': 'Reporting of anosmia, ageusia and other clinical symptoms', 'type': 'BIOLOGICAL', 'description': 'Reporting of anosmia, ageusia and other clinical symptoms related to COVID-19 - CODA test - SARS-CoV2 RT-PCR and ELISA', 'armGroupLabels': ['COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Fréderic VENAIL, PU-PH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UH Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}