Study of the Pathogenesis of Olfactory Disorders in COVID-19

NCT ID: NCT04366934

Last Updated: 2025-09-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-04

Study Completion Date

2020-10-29

Brief Summary

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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.

Detailed Description

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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.

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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Coronavirus Infection Severe Acute Respiratory Syndrome Sars-CoV2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type OTHER

Nasal swab

Taste and olfactory function evaluation

Intervention Type OTHER

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

Intervention Type OTHER

Nasal swab

Taste and olfactory function evaluation

Intervention Type OTHER

Taste and olfactory function evaluation

Interventions

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Nasal swab

Nasal swab

Intervention Type OTHER

Taste and olfactory function evaluation

Taste and olfactory function evaluation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

COVID-19 patients

* 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

* Refusal or contraindication to nasal swab
* Presence of nasal sinus pathology
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital Lariboisière, AP-HP

UNKNOWN

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Françoise LAZARINI, PhD

Role: STUDY_DIRECTOR

Institut Pasteur

Locations

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Hôpital Lariboisière, Policlinique

Paris, , France

Site Status

Hôpital Lariboisière, Service ORL

Paris, , France

Site Status

Countries

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France

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.

Reference Type RESULT
PMID: 33941622 (View on PubMed)

Other Identifiers

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2020-021

Identifier Type: -

Identifier Source: org_study_id

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