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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Longitudinal and Comparative Study of Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients

Conditions
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Olfaction Disorders, COVID-19

Intervention / Treatment
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* Diagnostic Test: ENT exam
* Diagnostic Test: Olfactometry
* Diagnostic Test: Brain MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: anosmic or normosmic COVID-19 patients<br>Patients will undergo ENT exams, olfactometry and MRI. | Diagnostic Test: ENT exam<br>* ENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy.<br>Diagnostic Test: Olfactometry<br>* Olfactometry test using odorous pens (Sniffin's stick test).<br>Diagnostic Test: Brain MRI<br>* Brain MRI focused on the olfactory bulbs (3 teslas).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Sniffin' test score (T threshold score, D discrimination score, I identification score). | initial examination, 6 week to 2 months, 6 to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anosmia, smell disorder, COVID-19, MRI