Study of the Pathogenesis of Olfactory Disorders in COVID-19 (COVIDSMELL)

January 28, 2021 updated by: Institut Pasteur
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Hôpital Lariboisière, Policlinique
      • Paris, France
        • Hôpital Lariboisière, Service ORL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COVID-19 patients and control subjects

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Nasal swab
Nasal swab
Other: 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
Other: Nasal swab
Nasal swab
Other: Taste and olfactory function evaluation
Taste and olfactory function evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular and cellular defects in olfactory epithelium
Time Frame: 30 months
Ratio of olfactory sensory cells in the nasal cytological sample
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological mechanisms involved in the pathogenesis of the disease
Time Frame: 30 months
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
Epidemiological characteristics
Time Frame: 30 months
Demographic variables (sex, age, blood type), risk factors (tobacco, overweight, diabetes, rhinosinusitis disease, respiratory allergy)
30 months
Olfactory and taste dysfunction
Time Frame: 30 months
Self-questionnaire taste and smell survey (TTS)
30 months
Olfactory and taste dysfunction
Time Frame: 30 months
Visual analogue scale (VAS) (units from 0 normal perception to 100 no perception)
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Collaborators

Hôpital Lariboisière, AP-HP

Investigators

  • Study Director: Françoise LAZARINI, PhD, Institut Pasteur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2020

Primary Completion (Actual)

October 29, 2020

Study Completion (Actual)

October 29, 2020

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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