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

Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients

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: NCT04526054
Recruitment Status : Recruiting
First Posted : August 25, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Hôpital Raymond Poincaré
Information provided by (Responsible Party):
Hopital Foch

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Olfactory and gustatory disorders are prevalent symptoms in European COVID-19 patients. This study aimed to detect these disturbances among positive COVID-19 patients (symptom not initially highlighted by the patient and not sought by caregivers) in order to allow early management of olfactory and gustatory dysfunction.

Condition or disease Intervention/treatment Phase
Olfaction Disorders COVID-19 Diagnostic Test: ENT exam Diagnostic Test: Olfactometry Diagnostic Test: Brain MRI Not Applicable

Detailed Description:

Several medical teams have recently shown that disturbances of smell and taste are common and can be a precursor and even an isolated sign of COVID-19 involvement. Preliminary results suggest the presence of clinical MRI abnormalities, particularly in the olfactory bulbs in anosmic patients with COVID-19.

Anosmia and taste disturbance are early warning signs that could be important in improving the detection and diagnosis of COVID-19, and also in monitoring disease. In addition, disturbances in smell and taste could be an aid in establishing the prognosis of the clinical course of the viral disease. The question of olfactory recovery is also fundamental. To date, we do not know the possibilities of recovery from COVID-19 post viral anosmia. ENT exams, olfactometry and MRI are proposed to study these phenomena.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Longitudinal and Comparative Study of Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
Actual Study Start Date : September 3, 2020
Estimated Primary Completion Date : September 3, 2021
Estimated Study Completion Date : September 3, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
anosmic or normosmic COVID-19 patients
Patients will undergo ENT exams, olfactometry and MRI.
 Diagnostic Test: ENT exam
ENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy.

Diagnostic Test: Olfactometry
Olfactometry test using odorous pens (Sniffin's stick test).

Diagnostic Test: Brain MRI
Brain MRI focused on the olfactory bulbs (3 teslas).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To compare the qualitative and quantitative morphological abnormalities of the olfactory bulb detected by MRI on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients. [ Time Frame: initial examination ]
    Intensity ratio calculated between average signals of the olfactory bulb and the frontal white matter on a 3-Tesla MRI scanner.

  2. To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients. [ Time Frame: initial examination ]
    Sniffin' test score (T threshold score, D discrimination score, I identification score).


Secondary Outcome Measures :
  1. Longitudinal evaluation of qualitative and quantitative abnormalities of olfactory bulbs on MRI in in COVID-19 anosmic patient at initial examination, between 6 weeks and 2 months and between 6 and 9 months. [ Time Frame: initial examination, 6 week to 2 months, 6 to 9 months ]
    Intensity ratio calculated between average signals of the olfactory bulb and the frontal white matter on a 3-Tesla MRI scanner at initial examination, between 6 weeks and 2 months and between 6 and 9 months.

  2. To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients. [ Time Frame: initial examination, 6 week to 2 months, 6 to 9 months ]
    Sniffin' test score (T threshold score, D discrimination score, I identification score).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:   No
Criteria

Inclusion Criteria:

  • Patient aged 18 or over
  • Patient with or without a sense of smell diagnosed with a positive COVID-19 PCR test by nasopharyngeal swab in one of the investigation centers
  • Patient who has already undergone cerebral MRI and olfactometry, as part of their routine care, within 3 days of being diagnosed with COVID-19+ or who agrees to undergo cerebral MRI and olfactometry within 3 days of being diagnosed with COVID-19+.
  • Patient who signed a consent form
  • Patient being affiliated to a Health Insurance plan

Exclusion Criteria:

  • History of chronic rhino-sinusitis with or without polyp (s)
  • History of major craniofacial trauma that led to loss of smell
  • History of chronic sense of smell
  • Diagnosis of Parkinson's disease or Alzheimer's disease
  • Refusal to perform the 3 MRIs
  • Refusal to participate in the study
  • Pregnant, parturient or lactating woman
  • Patient with contraindications to performing MRI
  • Patient not speaking or understanding French
  • Patient deprived of liberty or under guardianship
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04526054


Contacts
Layout table for location contacts
Contact: Elisabeth Hulier-Ammar, Dr 0033146251175 ext +33 e.hulier-ammar@hopital-foch.com

Locations
Layout table for location information
France
Hopital Foch Recruiting
Suresnes, Ile-de-France, France, 92150
Contact: Elisabeth Hulier-Ammar, Dr    0033146251175 ext +33    e.hulier-ammar@hopital-foch.com   
Hopital Raymond Poincare Recruiting
Garches, France, 92380
Contact: Robert-Yves CARLIER, Dr         
Sponsors and Collaborators
Hopital Foch
Hôpital Raymond Poincaré
Investigators
Layout table for investigator information
Study Director: Stephane Hans, Pr Hopital Foch, Suresnes
Principal Investigator: Robert-Yves Carlier, Pr Hopital Raymond Poincare, Garches
Principal Investigator: Jerome Lechien, Dr Hopital Foch, Suresnes
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT04526054    
Other Study ID Numbers: 2020_0057
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 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 Hopital Foch:
anosmia
smell disorder
COVID-19
MRI
Additional relevant MeSH terms:
Layout table for MeSH terms
Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases