NCT04366934

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

May 4, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2020

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

April 22, 2020

Last Update Submit

September 18, 2025

Conditions

Coronavirus InfectionSevere Acute Respiratory SyndromeSars-CoV2

Keywords

SARS-CoV-2Sense of smell disordersAnosmiaOlfactionNasal neuroepitheliumOlfactory mucosa

Outcome Measures

Primary Outcomes (1)

  • Molecular and cellular defects in olfactory epithelium

    Ratio of olfactory sensory cells in the nasal cytological sample

    30 months

Secondary Outcomes (4)

  • Biological mechanisms involved in the pathogenesis of the disease

    30 months

  • Epidemiological characteristics

    30 months

  • Olfactory and taste dysfunction

    30 months

  • Olfactory and taste dysfunction

    30 months

Study Arms (2)

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 swabOther: 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 swabOther: Taste and olfactory function evaluation

Interventions

Nasal swabOTHER

Nasal swab

COVID-19 patientsControl subjects
Taste and olfactory function evaluationOTHER

Taste and olfactory function evaluation

COVID-19 patientsControl subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COVID-19 patients and control subjects

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Lariboisière, Policlinique

Paris, France

Location

Hôpital Lariboisière, Service ORL

Paris, France

Location

Related Publications (1)

  • 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.

    PMID: 33941622RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal swabs

MeSH Terms

Conditions

Coronavirus InfectionsSevere Acute Respiratory SyndromeAnosmia

Interventions

Taste

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesOlfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Françoise LAZARINI, PhD

    Institut Pasteur

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 29, 2020

Study Start

May 4, 2020

Primary Completion

October 29, 2020

Study Completion

October 29, 2020

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)