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Completed

NCT Number: NCT04526054

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch, Suresnes, Île-de-France Region, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ENT exam

Diagnostic Test

ENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy.

Olfactometry

Diagnostic Test

Olfactometry test using odorous pens (Sniffin's stick test).

Brain MRI

Diagnostic Test

Brain MRI focused on the olfactory bulbs (3 teslas).

Primary outcomes

  1. To compare the qualitative and quantitative morphological abnormalities of the olfactory bulb detected by MRI on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.

    Time frame: initial examination

    Intensity ratio calculated between average signals of the olfactory bulb and the frontal white matter on a 3-Tesla MRI scanner.

  2. To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.

    Time frame: initial examination

    Sniffin' test score (T threshold score, D discrimination score, I identification score).

Secondary outcomes

  1. Longitudinal evaluation of qualitative and quantitative abnormalities of olfactory bulbs on MRI in in COVID-19 anosmic patient at initial examination, between 6 weeks and 2 months and between 6 and 9 months.

    Time frame: initial examination, 6 week to 2 months, 6 to 9 months

    Intensity ratio calculated between average signals of the olfactory bulb and the frontal white matter on a 3-Tesla MRI scanner at initial examination, between 6 weeks and 2 months and between 6 and 9 months.

  2. To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.

    Time frame: initial examination, 6 week to 2 months, 6 to 9 months

    Sniffin' test score (T threshold score, D discrimination score, I identification score).

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Collaborators

  • Hôpital Raymond Poincaré

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2020
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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