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

C

Centre Hospitalier Universitaire de Nīmes

Status

Withdrawn

Conditions

Anosmia
Covid-19

Treatments

Other: Brain MRI scan

Study type

Observational

Funder types

Other

Identifiers

NCT04408391
NIMAO/2020-01/BL-001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

COVID-19 patients with anosmia
Description:
Patients reporting loss of smell and scoring \< 30 on a VAS 0-100 for ability to detect n-Butanol diluted 1/1000
Treatment:
Other: Brain MRI scan
COVID-19 patients without anosmia
Description:
Patients reporting no loss of smell and scoring \> 80 on a VAS 0-100 for ability to detect n-Butanol diluted 1/16000
Treatment:
Other: Brain MRI scan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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