Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 47 of 611 for:    Taste Disorders AND taste

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366934
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
Hôpital Lariboisière, AP-HP
Information provided by (Responsible Party):
Institut Pasteur

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.

Condition or disease Intervention/treatment
Coronavirus Infection Severe Acute Respiratory Syndrome Sars-CoV2 Other: Nasal swab Other: Taste and olfactory function evaluation

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Study of the Pathogenesis of Olfactory Disorders in COVID-19
Actual Study Start Date : May 4, 2020
Estimated Primary Completion Date : September 15, 2022
Estimated Study Completion Date : September 15, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Molecular and cellular defects in olfactory epithelium [ Time Frame: 30 months ]
    Ratio of olfactory sensory cells in the nasal cytological sample


Secondary Outcome Measures :
  1. 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)

  2. Epidemiological characteristics [ Time Frame: 30 months ]
    Demographic variables (sex, age, blood type), risk factors (tobacco, overweight, diabetes, rhinosinusitis disease, respiratory allergy)

  3. Olfactory and taste dysfunction [ Time Frame: 30 months ]
    Self-questionnaire taste and smell survey (TTS)

  4. Olfactory and taste dysfunction [ Time Frame: 30 months ]
    Visual analogue scale (VAS) (units from 0 normal perception to 100 no perception)


Biospecimen Retention:   Samples Without DNA
Nasal swabs


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
COVID-19 patients and control subjects
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366934


Contacts
Layout table for location contacts
Contact: Françoise LAZARINI, PhD +33 (0) 1 44 38 92 74 francoise.lazarini-serandour@pasteur.fr

Locations
Layout table for location information
France
Hôpital Lariboisière, Policlinique Recruiting
Paris, France
Contact: Caroline APARICIO, MD    +33(0)149958124    caroline.aparicio@aphp.fr   
Principal Investigator: Carolina APARICIO, MD         
Hôpital Lariboisière, Service ORL Not yet recruiting
Paris, France
Contact: Charlotte HAUTEFORT, MD    +33(0)149959197    charlotte.hautefort@aphp.fr   
Principal Investigator: Charlotte HAUTEFORT, MD         
Sub-Investigator: Benjamin VERILLAUD, MD         
Sponsors and Collaborators
Institut Pasteur
Hôpital Lariboisière, AP-HP
Investigators
Layout table for investigator information
Study Director: Françoise LAZARINI, PhD Institut Pasteur
Layout table for additonal information
Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT04366934    
Other Study ID Numbers: 2020-021
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Pasteur:
SARS-CoV-2
Sense of smell disorders
Anosmia
Olfaction
Nasal neuroepithelium
Olfactory mucosa
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases