Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia (ANOSIRM)

Descriptive Pilot Study of Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia

To date there is no brain imaging and olfactory data available in COVID-19 positive patients with anosmia. By describing the pathophysiological characteristics underlying the olfactory symptoms and clinical characteristics of COVID-19 infection, the study investigators wish to compare the MRI aspects obtained in COVID-19 patients with and without anosmia, in the absence of other underlying neurological disorders.

Study Overview

• Status: Withdrawn
• Conditions: Covid-19; Anosmia
• Intervention / Treatment: Other: Brain MRI scan

Detailed Description

Brain mapping of COVID-19 patients with or without anosmia will allow better understanding of the mechanisms leading to the onset of these symptoms and will provide a pathophysiological basis for the therapeutic interventions to improve the clinical prognosis of affected patients.

The study investigators hypothesize that in COVID-19 patients witch anosmia the brain mapping objectified by an MRI examination is modified and that there are functional abnormalities in the brain in these patients.

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU de Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients consulting the CAREB or hospitalized at the Nîmes teaching hospital due to COVID-19 infection confirmed by RT-PCR and / or chest CT or clinical characteristics (i.e an epidemic history and 2 clinical manifestations or at least 3 clinical manifestations) with or without anosmia.

Description

Inclusion Criteria:

• Consecutive adult patients consulting the CAREB or hospitalized at the Nîmes teaching hospital due to COVID-19 infection (fever, persistent cough, tiredness, shortness of breath, diarrhea, abdominal pain, chest pain, sore throat, loss of smell or taste)
• COVID-19 confirmed by RT-PCR and / or chest CT or clinical characteristics (i.e an epidemic history and 2 clinical manifestations or at least 3 clinical manifestations)
• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan "with anosmia" group:
• scoring < 30 on a VAS 0-100 for olfactory ability
• Responding "yes" to question "have you lost your sense of smell in the last few days?"
• Negative result to olfactory test with n-Butanol diluted to 1/1000. "without anosmia" group:
• scoring < 80 on a VAS 0-100 for olfactory ability
• Responding "no" to question "have you lost your sense of smell in the last few days?"
• Positive result to olfactory test with n-Butanol diluted to 1/16000.

Exclusion Criteria:

• Patient suffering from serious medical problems or hospitalized in an intensive care unit for invasive ventilation or severe dyspnea.
• Patient with neurological (motor, sensitive or cognitive), neuropsychiatric or vascular disorders.
• Patient with a contraindication to MRI (pace maker, claustrophobic patient, metallic heart valve, etc.).
• Patient with a history of rhinological pathology or a sense of smell problem.
• Patient with known neurological, psychiatric or neuroradiological manifestation.The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
• The subject is unable to express consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• Patient is pregnant, parturient or breastfeeding

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 patients with anosmia; Patients reporting loss of smell and scoring < 30 on a VAS 0-100 for ability to detect n-Butanol diluted 1/1000	Other: Brain MRI scan; Resting state, functional, structural and morphometric MRI; diffusion tensor imaging on a 3-Tesla MRI scanner
COVID-19 patients without anosmia; Patients reporting no loss of smell and scoring > 80 on a VAS 0-100 for ability to detect n-Butanol diluted 1/16000	Other: Brain MRI scan; Resting state, functional, structural and morphometric MRI; diffusion tensor imaging on a 3-Tesla MRI scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain regional homogeneity between COVID-19 patients with and without anosmia	MRI; Voxels	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain regional homogeneity between COVID-19 patients with and without anosmia	MRI; Voxels	Month 3
Topography of supra- or sub-tentorial lesions between COVID-19 patients with and without anosmia	MRI; Voxels	Day 0
Fractional anisotropy between COVID-19 patients with and without anosmia	MRI; voxels, value between 0-1	Day 0
Fractional anisotropy between COVID-19 patients with and without anosmia	MRI; voxels, value between 0-1	Month 3
Mean diffusivity between COVID-19 patients with and without anosmia	MRI; mm2/s	Day 0
Mean diffusivity between COVID-19 patients with and without anosmia	MRI; mm2/s	Month 3
Radial diffusivity between COVID-19 patients with and without anosmia	MRI; mm2/s	Day 0
Radial diffusivity between COVID-19 patients with and without anosmia	MRI; mm2/s	Month 3
Self-assessed olfactory and gustatory test	Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today	Day 0
Self-assessed olfactory and gustatory test	Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today	Day 8
Self-assessed olfactory and gustatory test	Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today	Month 1
Self-assessed olfactory and gustatory test	Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today	Month 2
Ability to detect odor	Ability to smell 1.5ml air freshner on a 0-100 VAS scale (cut-offs: strang (>80), moderate (40-80), attenuated (<40)	Day 0
Ability to taste a pinch of sugar	Patient asked to describe whether a pinch of sugar on their tongue taste sweet or salty	Day 0
Presence of thrombotic and hemorrhagic lesions	MRI: absence/presence	Day 0
Presence of thrombotic and hemorrhagic lesions	MRI: absence/presence	Month 3
Presence of lesions with hyperintensity	Short Ti Inversion Recovery (STIR); presence/absence	Day 0
Presence of lesions with hyperintensity	Short Ti Inversion Recovery (STIR); presence/absence	Month 3
Projection network analysis of all patients	beta voxels	Day 0
Projection network analysis of all patients	beta voxels	Month 3
Blinded independent component analysis of all patients	beta voxels	Day 0
Blinded independent component analysis of all patients	beta voxels	Month 3
default mode network analysis of all patients	beta voxels	Day 0
default mode network analysis of all patients	beta voxels	Month 3
executive control network analysis of all patients	beta voxels	Day 0
executive control network analysis of all patients	beta voxels	Month 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Benjamin Lallemant, Chu Nimes

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): July 6, 2020
• Study Completion (Actual): July 6, 2020

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurologic Manifestations; Sensation Disorders; Olfaction Disorders; COVID-19; Anosmia
• Other Study ID Numbers: NIMAO/2020-01/BL-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No