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

NCT04408391 | Withdrawn

• 1 other identifier: NIMAO/2020-01/BL-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19; Anosmia

Outcome Measures

Primary Outcomes (1)

• Brain regional homogeneity between COVID-19 patients with and without anosmia

  MRI; Voxels

  Day 0

Secondary Outcomes (26)

• Brain regional homogeneity between COVID-19 patients with and without anosmia

  Month 3

• Topography of supra- or sub-tentorial lesions between COVID-19 patients with and without anosmia

  Day 0

• Fractional anisotropy between COVID-19 patients with and without anosmia

  Day 0

• Fractional anisotropy between COVID-19 patients with and without anosmia

  Month 3

• Mean diffusivity between COVID-19 patients with and without anosmia

  Day 0

Study Arms (2)

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

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

Interventions

Brain MRI scan OTHER

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

COVID-19 patients with anosmia; COVID-19 patients without anosmia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, France

Location

MeSH Terms

Conditions

COVID-19; Anosmia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin Lallemant

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: May 20, 2020
• Primary Completion: July 6, 2020
• Study Completion: July 6, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Locations

FR (1)