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

• ClinicalTrials.gov Identifier: NCT04526054
• Recruitment Status: Completed
• First Posted: August 25, 2020
• Last Update Posted: August 3, 2022
• Sponsor: Hopital Foch
• Collaborator: Hôpital Raymond Poincaré
• Information provided by (Responsible Party): Hopital Foch

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Olfaction Disorders; COVID-19	Diagnostic Test: ENT exam; Diagnostic Test: Olfactometry; Diagnostic Test: Brain MRI	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Longitudinal and Comparative Study of Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
• Actual Study Start Date: September 3, 2020
• Actual Primary Completion Date: September 3, 2021
• Actual Study Completion Date: September 3, 2021

Arms and Interventions

Arm	Intervention/treatment
anosmic or normosmic COVID-19 patients; Patients will undergo ENT exams, olfactometry and MRI.	Diagnostic Test: ENT exam; ENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy.; Diagnostic Test: Olfactometry; Olfactometry test using odorous pens (Sniffin's stick test).; Diagnostic Test: Brain MRI; Brain MRI focused on the olfactory bulbs (3 teslas).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

France

Hopital Foch

Suresnes, Ile-de-France, France, 92150

Hopital Raymond Poincare

Garches, France, 92380

Sponsors and Collaborators

Hopital Foch

Hôpital Raymond Poincaré

Investigators

• Study Director: Stephane Hans, Pr; Hopital Foch, Suresnes
• Principal Investigator: Robert-Yves Carlier, Pr; Hopital Raymond Poincare, Garches
• Principal Investigator: Jerome Lechien, Dr; Hopital Foch, Suresnes

More Information

Publications:

Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT04526054
• Other Study ID Numbers: 2020_0057
• First Posted: August 25, 2020
• Last Update Posted: August 3, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hopital Foch:

anosmia; smell disorder; COVID-19; MRI

Additional relevant MeSH terms:

COVID-19; Olfaction Disorders; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases