Back to resultsMorphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
Primary Purpose
Olfaction Disorders, COVID-19
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ENT exam
Olfactometry
Brain MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Olfaction Disorders focused on measuring anosmia, smell disorder, COVID-19, MRI
Eligibility 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
Sites / Locations
- Hopital Foch
- Hopital Raymond Poincare
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
anosmic or normosmic COVID-19 patients
Arm Description
Patients will undergo ENT exams, olfactometry and MRI.
Outcomes
Primary Outcome Measures
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.
Intensity ratio calculated between average signals of the olfactory bulb and the frontal white matter on a 3-Tesla MRI scanner.
To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
Sniffin' test score (T threshold score, D discrimination score, I identification score).
Secondary Outcome Measures
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.
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.
To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
Sniffin' test score (T threshold score, D discrimination score, I identification score).
Full Information
NCT ID
NCT04526054
First Posted
August 3, 2020
Last Updated
August 2, 2022
Sponsor
Hopital Foch
Collaborators
Hôpital Raymond Poincaré
1. Study Identification
Unique Protocol Identification Number
NCT04526054
Brief Title
Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
Official Title
Longitudinal and Comparative Study of Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
September 3, 2021 (Actual)
Study Completion Date
September 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
Collaborators
Hôpital Raymond Poincaré
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olfaction Disorders, COVID-19
Keywords
anosmia, smell disorder, COVID-19, MRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anosmic or normosmic COVID-19 patients
Arm Type
Other
Arm Description
Patients will undergo ENT exams, olfactometry and MRI.
Intervention Type
Diagnostic Test
Intervention Name(s)
ENT exam
Intervention Description
ENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy.
Intervention Type
Diagnostic Test
Intervention Name(s)
Olfactometry
Intervention Description
Olfactometry test using odorous pens (Sniffin's stick test).
Intervention Type
Diagnostic Test
Intervention Name(s)
Brain MRI
Intervention Description
Brain MRI focused on the olfactory bulbs (3 teslas).
Primary Outcome Measure Information:
Title
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.
Description
Intensity ratio calculated between average signals of the olfactory bulb and the frontal white matter on a 3-Tesla MRI scanner.
Time Frame
initial examination
Title
To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
Description
Sniffin' test score (T threshold score, D discrimination score, I identification score).
Time Frame
initial examination
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
initial examination, 6 week to 2 months, 6 to 9 months
Title
To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
Description
Sniffin' test score (T threshold score, D discrimination score, I identification score).
Time Frame
initial examination, 6 week to 2 months, 6 to 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane Hans, Pr
Organizational Affiliation
Hopital Foch, Suresnes
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert-Yves Carlier, Pr
Organizational Affiliation
Hopital Raymond Poincare, Garches
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jerome Lechien, Dr
Organizational Affiliation
Hopital Foch, Suresnes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
State/Province
Ile-de-France
ZIP/Postal Code
92150
Country
France
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32253535
Citation
Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6.
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Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
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