Investigation of the Persistence of SARS-CoV-2 in the Olfactory Mucosa of Patients With Prolonged Symptoms of COVID-19 With Neurocognitive Complaints: a Prospective Cross-sectional Multicenter Case / Control Study (NEUROCOVID)

MVT_2021_26

NEUROCOVID is a prospective multicenter study comparing the proportion of patients with SARS-CoV-2 viral RNA at the level of the olfactory clefts in a group of cases compared to a group of controls as well as the correlations between the virological and cellular abnormalities observed in the olfactory mucosa and the severity of the clinical neurological profile

2022-07-01

2024-07-01

2024-07-01

Recruiting

50

Inclusion Criteria: Common to cases and controls: * Age ≥ 18 years old and \<60 years old * Good oral and written command of French * Level of education ≥ 7 years of schooling * Initial episode of COVID-19 within 2 to 12 months * Symptomatic initial episode of COVID-19 * Initial symptoms not explained by another diagnosis * Initial episode documented by RT-PCR positive for SARS-CoV-2 and / or positive antigen test and / or positive serology (in the absence of vaccination) * Express consent to participate in the study * Affiliate or beneficiary of a social security scheme Case group: * Presence of at least one of the initial symptoms beyond 4 weeks following the onset of the acute phase of the disease * Prolonged symptoms not explained by another diagnosis with no known link to COVID-19 * Neurocognitive complaint (s) previously objectified by a neurologist and after completion of a neuro-psychological assessment * Impact of neurocognitive disorders on daily life authenticated by a Glasgow outcome scale extended ≤ 7 (see appendix 1) * Evolution of complaints for 2 to 12 months compared to the date of their first appearance Exclusion Criteria: Exclusion criteria common to cases and controls: * Person benefiting from a legal protection measure * Pregnant or breastfeeding woman * At least one neurological pathology among: * encephalopathy * encephalitis * severe neurological form of the initial episode of COVID-19 * neurodegenerative disease * History of stroke * Serious psychiatric history * Known nasal sinus pathology * Hemostatic disorder * Taking aspirin in the 15 days preceding the sample * Treatment with anticoagulants * Known allergy to lidocaine Secondary exclusion criteria for controls: - Positive SARS-CoV-2 RT-PCR on nasopharyngeal sample on the day of inclusion

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-10-26