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

NCT ID: NCT04408391

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2020-07-06

Brief 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.

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.

Conditions

Covid-19; Anosmia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Brain MRI scan

Intervention Type: OTHER

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

Brain MRI scan

Intervention Type: OTHER

Resting state, functional, structural and morphometric MRI; diffusion tensor imaging on a 3-Tesla MRI scanner

Interventions

Brain MRI scan

Resting state, functional, structural and morphometric MRI; diffusion tensor imaging on a 3-Tesla MRI scanner

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Lallemant

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

CHU de Nimes

Nîmes, , France

Countries

France

Other Identifiers

NIMAO/2020-01/BL-001

Identifier Type: -

Identifier Source: org_study_id