Status:
COMPLETED
Investigation of the Persistence of SARS-CoV-2 in the Olfactory Mucosa of Patients With Prolonged Symptoms of COVID-19
Lead Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Collaborating Sponsors:
Hotel Dieu Hospital
Institut Pasteur
Conditions:
SARS-CoV-2 Infection
Cognitive Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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...
Detailed Description
More than 15% of people who developed COVID-19 would still have at least one symptom six months older. In France, this would concern several hundred thousand people. The societal consequences are impo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2025
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT05220241
Start Date
July 1 2022
End Date
July 10 2025
Last Update
December 17 2025
Active Locations (2)
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1
Hôpital Lariboisière-Fernand-Widal
Paris, France, 75010
2
Hôpital Fondation A. de Rothschild
Paris, France, 75019