ClinicalTrials.Veeva

Menu

Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients

H

Hopital Foch

Status

Completed

Conditions

COVID-19
Olfaction Disorders

Treatments

Diagnostic Test: Brain MRI
Diagnostic Test: ENT exam
Diagnostic Test: Olfactometry

Study type

Interventional

Funder types

Other

Identifiers

NCT04526054
2020_0057

Details and patient eligibility

About

Olfactory and gustatory disorders are prevalent symptoms in European COVID-19 patients. This study aimed to detect these disturbances among positive COVID-19 patients (symptom not initially highlighted by the patient and not sought by caregivers) in order to allow early management of olfactory and gustatory dysfunction.

Full description

Several medical teams have recently shown that disturbances of smell and taste are common and can be a precursor and even an isolated sign of COVID-19 involvement. Preliminary results suggest the presence of clinical MRI abnormalities, particularly in the olfactory bulbs in anosmic patients with COVID-19.

Anosmia and taste disturbance are early warning signs that could be important in improving the detection and diagnosis of COVID-19, and also in monitoring disease. In addition, disturbances in smell and taste could be an aid in establishing the prognosis of the clinical course of the viral disease. The question of olfactory recovery is also fundamental. To date, we do not know the possibilities of recovery from COVID-19 post viral anosmia. ENT exams, olfactometry and MRI are proposed to study these phenomena.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient aged 18 or over
  • Patient with or without a sense of smell diagnosed with a positive COVID-19 PCR test by nasopharyngeal swab in one of the investigation centers
  • Patient who has already undergone cerebral MRI and olfactometry, as part of their routine care, within 3 days of being diagnosed with COVID-19+ or who agrees to undergo cerebral MRI and olfactometry within 3 days of being diagnosed with COVID-19+.
  • Patient who signed a consent form
  • Patient being affiliated to a Health Insurance plan

Exclusion criteria

  • History of chronic rhino-sinusitis with or without polyp (s)
  • History of major craniofacial trauma that led to loss of smell
  • History of chronic sense of smell
  • Diagnosis of Parkinson's disease or Alzheimer's disease
  • Refusal to perform the 3 MRIs
  • Refusal to participate in the study
  • Pregnant, parturient or lactating woman
  • Patient with contraindications to performing MRI
  • Patient not speaking or understanding French
  • Patient deprived of liberty or under guardianship

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

anosmic or normosmic COVID-19 patients
Other group
Description:
Patients will undergo ENT exams, olfactometry and MRI.
Treatment:
Diagnostic Test: Olfactometry
Diagnostic Test: ENT exam
Diagnostic Test: Brain MRI

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems