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

Sponsor

Hopital Foch (Other)

Overall Status

Completed

CT.gov ID

NCT04526054

Collaborator

Hôpital Raymond Poincaré (Other)

Enrollment

Locations

Arm

Actual Duration (Months)

6.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Olfaction Disorders COVID-19	Diagnostic Test: ENT exam Diagnostic Test: Olfactometry Diagnostic Test: Brain MRI	N/A

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

Study Type:

Interventional

Actual Enrollment :

13 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 :

Sep 3, 2020

Actual Primary Completion Date :

Sep 3, 2021

Actual Study Completion Date :

Sep 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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).

Arm

Intervention/Treatment

Other: 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

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. [initial examination]
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. [initial examination]
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. [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.
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]
Sniffin' test score (T threshold score, D discrimination score, I identification score).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hopital Foch	Suresnes	Ile-de-France	France	92150
2	Hopital Raymond Poincare	Garches		France	92380

Sponsors and Collaborators

Hopital Foch
Hôpital Raymond Poincaré

Investigators

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