Clinical trial NCT04366934: Study of the Pathogenesis of Olfactory Disorders in COVID-19
Official title: Study of the Pathogenesis of Olfactory Disorders in COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
Severe Acute Respiratory Syndrome
Sars-CoV2
Keywords: SARS-CoV-2
Sense of smell disorders
Anosmia
Olfaction
Nasal neuroepithelium
Olfactory mucosa
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Hôpital Lariboisière, AP-HP
First posted: 2020-04-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients and control subjects

Brief summary: 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: 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.

Eligibility criteria: 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 (both COVID-19 patients and controls):

* Refusal or contraindication to nasal swab
* Presence of nasal sinus pathology

Primary outcomes:
measure: Molecular and cellular defects in olfactory epithelium
timeFrame: 30 months
Secondary outcomes:
measure: Biological mechanisms involved in the pathogenesis of the disease
timeFrame: 30 months
measure: Epidemiological characteristics
timeFrame: 30 months
measure: Olfactory and taste dysfunction
timeFrame: 30 months
measure: Olfactory and taste dysfunction
timeFrame: 30 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière, Policlinique
city: Paris
country: France
facility: Hôpital Lariboisière, Service ORL
Study officials:
affiliation: Institut Pasteur
name: Françoise LAZARINI, PhD
role: STUDY_DIRECTOR
References: