Investigating the persistence of SARS-CoV-2 in the olfactory mucosa of patients with prolonged COVID-19 symptoms
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)
This study is testing whether the virus that causes COVID-19 sticks around in the nose of people who have had long-lasting symptoms, to see how it might relate to problems with thinking and senses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT05220241 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the presence of SARS-CoV-2 viral RNA in the olfactory mucosa of patients experiencing prolonged symptoms of COVID-19 against a control group. It will assess the correlation between viral persistence and neurological symptoms, including cognitive disorders and sensory disturbances. Participants will undergo nasopharyngeal swabs for RT-PCR testing to detect the virus. The study focuses on individuals aged 18 to 60 who have had documented COVID-19 symptoms lasting beyond four weeks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 who have experienced COVID-19 symptoms for more than four weeks and have documented evidence of the virus.
Not a fit: Patients with COVID-19 symptoms explained by other diagnoses or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of long COVID and lead to targeted treatments for patients suffering from prolonged symptoms.
How similar studies have performed: While some studies have explored viral persistence in immunocompromised individuals, this investigation into long COVID symptoms and viral presence is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris and 1 other locations
- Hôpital Lariboisière-Fernand-Widal — Paris, France (Not_yet_recruiting)
- Hôpital Fondation A. de Rothschild — Paris, France (Recruiting)
Study contacts
- Principal investigator: Mathieu Veyrat, Dr — Hôpital Fondation A. de Rothschild
- Study coordinator: Amélie Yavchitz, MD, PhD
- Email: ayavchitz@for.paris
- Phone: 0033148036454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.