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

Covid-19 Clinical Trial

— ANOSIRM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04408391
• Other study ID #: NIMAO/2020-01/BL-001
• Status: Withdrawn
• Start date: May 20, 2020
• Est. completion date: July 6, 2020

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 6, 2020
• Est. primary completion date: July 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anosmia
• Covid-19
• Olfaction Disorders

Intervention

Other:
• Brain MRI scan
Resting state, functional, structural and morphometric MRI; diffusion tensor imaging on a 3-Tesla MRI scanner

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain regional homogeneity between COVID-19 patients with and without anosmia	MRI; Voxels	Day 0
Secondary	Brain regional homogeneity between COVID-19 patients with and without anosmia	MRI; Voxels	Month 3
Secondary	Topography of supra- or sub-tentorial lesions between COVID-19 patients with and without anosmia	MRI; Voxels	Day 0
Secondary	Fractional anisotropy between COVID-19 patients with and without anosmia	MRI; voxels, value between 0-1	Day 0
Secondary	Fractional anisotropy between COVID-19 patients with and without anosmia	MRI; voxels, value between 0-1	Month 3
Secondary	Mean diffusivity between COVID-19 patients with and without anosmia	MRI; mm2/s	Day 0
Secondary	Mean diffusivity between COVID-19 patients with and without anosmia	MRI; mm2/s	Month 3
Secondary	Radial diffusivity between COVID-19 patients with and without anosmia	MRI; mm2/s	Day 0
Secondary	Radial diffusivity between COVID-19 patients with and without anosmia	MRI; mm2/s	Month 3
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Presence of thrombotic and hemorrhagic lesions	MRI: absence/presence	Day 0
Secondary	Presence of thrombotic and hemorrhagic lesions	MRI: absence/presence	Month 3
Secondary	Presence of lesions with hyperintensity	Short Ti Inversion Recovery (STIR); presence/absence	Day 0
Secondary	Presence of lesions with hyperintensity	Short Ti Inversion Recovery (STIR); presence/absence	Month 3
Secondary	Projection network analysis of all patients	beta voxels	Day 0
Secondary	Projection network analysis of all patients	beta voxels	Month 3
Secondary	Blinded independent component analysis of all patients	beta voxels	Day 0
Secondary	Blinded independent component analysis of all patients	beta voxels	Month 3
Secondary	default mode network analysis of all patients	beta voxels	Day 0
Secondary	default mode network analysis of all patients	beta voxels	Month 3
Secondary	executive control network analysis of all patients	beta voxels	Day 0
Secondary	executive control network analysis of all patients	beta voxels	Month 3