Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
Longitudinal and Comparative Study of Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
1 other identifier
interventional
13
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedStudy Start
First participant enrolled
September 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2021
CompletedAugust 3, 2022
August 1, 2022
1 year
August 3, 2020
August 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
initial examination
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).
initial examination
Secondary Outcomes (2)
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.
initial examination, 6 week to 2 months, 6 to 9 months
To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
initial examination, 6 week to 2 months, 6 to 9 months
Study Arms (1)
anosmic or normosmic COVID-19 patients
OTHERPatients will undergo ENT exams, olfactometry and MRI.
Interventions
ENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy.
Olfactometry test using odorous pens (Sniffin's stick test).
Brain MRI focused on the olfactory bulbs (3 teslas).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
- Hôpital Raymond Poincarécollaborator
Study Sites (2)
Hopital Raymond Poincare
Garches, 92380, France
Hopital Foch
Suresnes, Île-de-France Region, 92150, France
Related Publications (1)
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.
PMID: 32253535BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2020
First Posted
August 25, 2020
Study Start
September 3, 2020
Primary Completion
September 3, 2021
Study Completion
September 3, 2021
Last Updated
August 3, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share