Study of the Pathogenesis of Olfactory Disorders in COVID-19

Coronavirus Infection Clinical Trial

— COVIDSMELL  

Official title:

Study of the Pathogenesis of Olfactory Disorders in COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366934
• Other study ID #: 2020-021
• Status: Completed
• Start date: May 4, 2020
• Est. completion date: October 29, 2020

Study information

• Verified date: January 2021
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Sars-CoV2
• Severe Acute Respiratory Syndrome

Intervention

Other:
• Nasal swab
Nasal swab
• Taste and olfactory function evaluation
Taste and olfactory function evaluation

Locations

Country	Name	City	State
France	Hôpital Lariboisière, Policlinique	Paris
France	Hôpital Lariboisière, Service ORL	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut Pasteur	Hôpital Lariboisière, AP-HP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular and cellular defects in olfactory epithelium	Ratio of olfactory sensory cells in the nasal cytological sample	30 months
Secondary	Biological mechanisms involved in the pathogenesis of the disease	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)	30 months
Secondary	Epidemiological characteristics	Demographic variables (sex, age, blood type), risk factors (tobacco, overweight, diabetes, rhinosinusitis disease, respiratory allergy)	30 months
Secondary	Olfactory and taste dysfunction	Self-questionnaire taste and smell survey (TTS)	30 months
Secondary	Olfactory and taste dysfunction	Visual analogue scale (VAS) (units from 0 normal perception to 100 no perception)	30 months