Study of the Pathogenesis of Olfactory Disorders in COVID-19
NCT ID: NCT04366934
Last Updated: 2025-09-22
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
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COMPLETED
26 participants
OBSERVATIONAL
2020-05-04
2020-10-29
Brief Summary
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Detailed Description
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Acute anosmia observed in some patients with COVID-19 could result from:
* the direct infection of olfactory sensory neurons or neural stem cells of the olfactory mucosa,
* 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.
It 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.
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.
Following measures will be performed at inclusion :
* Taste and olfactory function evaluation by a self-questionnaire taste and smell survey (TTS) and a visual analogue scale (VAS)
* Nasal swab sampling for collection of epithelium cells and olfactory mucus.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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COVID-19 patients
Subject consulting in the Lariboisière hospital (Paris) in the context of the COVID-19 screening care for a suspected SARS-CoV-2 infection
Nasal swab
Nasal swab
Taste and olfactory function evaluation
Taste and olfactory function evaluation
Control subjects
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
Nasal swab
Nasal swab
Taste and olfactory function evaluation
Taste and olfactory function evaluation
Interventions
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Nasal swab
Nasal swab
Taste and olfactory function evaluation
Taste and olfactory function evaluation
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Subject consulting in the context of the COVID-19 screening care for a suspected SARS-CoV-2 infection
Controls
* Age \> 18 years
* 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
Exclusion Criteria
* Presence of nasal sinus pathology
18 Years
ALL
Yes
Sponsors
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Hôpital Lariboisière, AP-HP
UNKNOWN
Institut Pasteur
INDUSTRY
Responsible Party
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Principal Investigators
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Françoise LAZARINI, PhD
Role: STUDY_DIRECTOR
Institut Pasteur
Locations
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Hôpital Lariboisière, Policlinique
Paris, , France
Hôpital Lariboisière, Service ORL
Paris, , France
Countries
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References
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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.
Other Identifiers
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2020-021
Identifier Type: -
Identifier Source: org_study_id
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