Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-28 @ 10:03 PM
Study NCT ID:
NCT04366934
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2020-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Pathogenesis of Olfactory Disorders in COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D000086582', 'term': 'Anosmia'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'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': 'D013649', 'term': 'Taste'}], 'ancestors': [{'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Nasal swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Molecular and cellular defects in olfactory epithelium', 'timeFrame': '30 months', 'description': 'Ratio of olfactory sensory cells in the nasal cytological sample'}], 'secondaryOutcomes': [{'measure': 'Biological mechanisms involved in the pathogenesis of the disease', 'timeFrame': '30 months', 'description': 'Multiple measurements will be analyzed to characterize the immune and inflamatory status of the olfactory mucosa (presence of infiltrated immune cells, activation state of the immune cells in the epithelium, cytokine and interleukin level)'}, {'measure': 'Epidemiological characteristics', 'timeFrame': '30 months', 'description': 'Demographic variables (sex, age, blood type), risk factors (tobacco, overweight, diabetes, rhinosinusitis disease, respiratory allergy)'}, {'measure': 'Olfactory and taste dysfunction', 'timeFrame': '30 months', 'description': 'Self-questionnaire taste and smell survey (TTS)'}, {'measure': 'Olfactory and taste dysfunction', 'timeFrame': '30 months', 'description': 'Visual analogue scale (VAS) (units from 0 normal perception to 100 no perception)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Sense of smell disorders', 'Anosmia', 'Olfaction', 'Nasal neuroepithelium', 'Olfactory mucosa'], 'conditions': ['Coronavirus Infection', 'Severe Acute Respiratory Syndrome', 'Sars-CoV2']}, 'referencesModule': {'references': [{'pmid': '33941622', 'type': 'RESULT', 'citation': 'de Melo GD, Lazarini F, Levallois S, Hautefort C, Michel V, Larrous F, Verillaud B, Aparicio C, Wagner S, Gheusi G, Kergoat L, Kornobis E, Donati F, Cokelaer T, Hervochon R, Madec Y, Roze E, Salmon D, Bourhy H, Lecuit M, Lledo PM. COVID-19-related anosmia is associated with viral persistence and inflammation in human olfactory epithelium and brain infection in hamsters. Sci Transl Med. 2021 Jun 2;13(596):eabf8396. doi: 10.1126/scitranslmed.abf8396. Epub 2021 May 3.'}]}, 'descriptionModule': {'briefSummary': 'This study is a case-control study to characterize the molecular and cellular anomalies of the olfactory epithelium of COVID-19 patients with isolated anosmia, by comparison with the olfactory epithelium of non-infected subjects.', 'detailedDescription': 'Olfactory and taste dysfunctions are common and early onset in COVID-19, especially in pauci symptomatic patients, and may be the main clinical manifestations of the infection. Olfactory dysfunction could result from infection of the olfactory system by SARS-CoV-2 or from inflammation induced by the virus. While the recent development of COVID-19 pulmonary lesion research has revealed a viral, inflammatory and vascular origin, factors that cause olfactory disorders in COVID-19 are just beginning.\n\nAcute anosmia observed in some patients with COVID-19 could result from:\n\n* the direct infection of olfactory sensory neurons or neural stem cells of the olfactory mucosa,\n* an underlying inflammation of the olfactory mucosa, leading to possible neurodegeneration of olfactory sensory neurons, and neural stem cells of the olfactory mucosa, by analogy with the respiratory viruses responsible for chronic rhinosinusitis.\n\nIt is therefore necessary to conduct a virological, cellular, immunological and inflammatory study of the olfactory epithelium from COVID-19 patients with isolated anosmia to identify the origin of these olfactory disorders.\n\nThis study is a case-control study to characterize the molecular and cellular anomalies of the olfactory epithelium of COVID-19 patients with isolated anosmia, by comparison with the olfactory epithelium of non-infected subjects.\n\nFollowing measures will be performed at inclusion :\n\n* Taste and olfactory function evaluation by a self-questionnaire taste and smell survey (TTS) and a visual analogue scale (VAS)\n* Nasal swab sampling for collection of epithelium cells and olfactory mucus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COVID-19 patients and control subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCOVID-19 patients\n\n* Age \\> 18 years\n* Subject consulting in the context of the COVID-19 screening care for a suspected SARS-CoV-2 infection\n\nControls\n\n* Age \\> 18 years\n* Subject consulting in the ear, nose and throat department with no biologically confirmed COVID-19 or suspected COVID-19 in the past 8 weeks, and no symptoms suggestive of COVID-19 or another respiratory disease and therefore no recent anosmia or ageusia\n\nExclusion Criteria (both COVID-19 patients and controls):\n\n* Refusal or contraindication to nasal swab\n* Presence of nasal sinus pathology'}, 'identificationModule': {'nctId': 'NCT04366934', 'acronym': 'COVIDSMELL', 'briefTitle': 'Study of the Pathogenesis of Olfactory Disorders in COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut Pasteur'}, 'officialTitle': 'Study of the Pathogenesis of Olfactory Disorders in COVID-19', 'orgStudyIdInfo': {'id': '2020-021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 patients', 'description': 'Subject consulting in the Lariboisière hospital (Paris) in the context of the COVID-19 screening care for a suspected SARS-CoV-2 infection', 'interventionNames': ['Other: Nasal swab', 'Other: Taste and olfactory function evaluation']}, {'label': 'Control subjects', 'description': 'Subject consulting in the ear, nose and throat department at the Lariboisière hospital (Paris) with no biologically confirmed COVID-19 or suspected COVID-19 in the past 8 weeks, and no symptoms suggestive of COVID-19 or another respiratory disease and therefore no recent anosmia or ageusia', 'interventionNames': ['Other: Nasal swab', 'Other: Taste and olfactory function evaluation']}], 'interventions': [{'name': 'Nasal swab', 'type': 'OTHER', 'description': 'Nasal swab', 'armGroupLabels': ['COVID-19 patients', 'Control subjects']}, {'name': 'Taste and olfactory function evaluation', 'type': 'OTHER', 'description': 'Taste and olfactory function evaluation', 'armGroupLabels': ['COVID-19 patients', 'Control subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Lariboisière, Policlinique', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Lariboisière, Service ORL', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Françoise LAZARINI, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut Pasteur'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Pasteur', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hôpital Lariboisière, AP-HP', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}