Hôpital Lariboisière
Paris, 75010, France
NCT Number: NCT05133596
The COVID-19 pandemic is a novel medical challenge, particularly because of the systemic nature of this disease. Indeed, COVID-19 affects several organs and systems at once. The brain is affected in several ways: direct infection of nerve cells by SARS-CoV-2, inflammation of the central nervous system, severe systemic inflammation damaging nerve cells, global cerebral ischaemia related to respiratory failure, thromboembolic events related to increased intravascular coagulation and severe psychological stress. As a result, COVID-19 sometimes manifests as neurological and neuropsychiatric symptoms such as dizziness, sleep disturbances, cognitive deficits, delirium, or severe depression.
Sudden loss of smell is a common symptom associated with COVID-19 and SARS-CoV-2 infection of neurons in the olfactory system has been reported in both hamsters and humans. The vast majority of COVID-19 patients recover their olfactory function within a few weeks. However, a significant minority of infected individuals (1 in 5 cases) still suffers from olfactory disorders (anosmia, hyposmia and/or parosmia) several months after the primary infection. These olfactory disorders are frequently associated with depressive behaviour and cognitive complaints. In PET scans, it is even possible to correlate this cognitive dysfunction with hypometabolism of certain brain regions, including the olfactory gyrus.
This project proposes, during one year, to evaluate and follow the evolution of the olfactory capacities of patients suffering from persistent smell disorder since one year (+/- 4 months) following COVID-19. The issue is to study the link between viral persistence in the olfactory sensory organ, chronic inflammation, and central damage to the olfactory system. The follow-up of the evolution of olfactory and neurocognitive capacities, in an integrative way by means of molecular, physiological and behavioural approaches, will inform us on the specificities of "COVID-long" and on the level of peripheral and/or central damage of the olfactory system.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Paris, 75010, France
Prospective monocentric descriptive study. Evaluation of COVID-19 patients with persistent loss of smell during 2 visits at 1 year intervals (V1 and V2).
V1 :The following examinations will be carried out specifically for the research.
V2 :
All examinations performed at V1 will be repeated at V2.
If the following examinations are not carried out during care within 3 weeks of V2, they will be carried out as part of the research during this V2 visit.
The following explorations will be carried out:
In addition, MRI data from clinical care will be collected.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The investigator will conduct a clinical examination to rule out other causes of olfactory impairment independent of COVID-19. The investigator will also collect the following information: socio-demographic data (age, sex, blood type, weight, height, etc.), history of olfaction disorder symptoms, past or current treatments received and tobacco/alcohol consumption.
12ml-blood sample
Olfactory evoked potentials will be recorded during olfactory tests.
collection of olfactory slits cells.
Nasal endoscopy
Time frame: 24 months
To characterise the evolution of the olfactory capacities of patients suffering from persistent odour disorders following SARS-CoV-2 infection over the course of a year.
Time frame: 24 months
Describe the olfactory performance
Time frame: 24 months
Characterisation of the presence of SARS-CoV-2 by PCR in the olfactory mucosa.
Time frame: 24 months
Mapping analysis of the olfactory nerve of COVID-19 patients by MRI tractography technique.
Time frame: 24 months
Measurement of cellular and inflammatory markers in the olfactory mucosa.
Time frame: 24 months
To identify the neurological damage in patients.
Time frame: 24 months
To identify possible cognitive abnormalities in these patients with prolonged loss of smell.
Institut Pasteur
Industry
Acronym: ETOC
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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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