Investigation of the Persistence of SARS-CoV-2 in the Olfactory Mucosa of Patients With Prolonged Symptoms of COVID-19

NCT05220241 | Completed

• 1 other identifier: MVT_2021_26
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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 well as the correlations between the virological and cellular abnormalities observed in the olfactory mucosa and the severity of the clinical neurological profile

Conditions

SARS-CoV-2 Infection; Cognitive Disorder

Outcome Measures

Primary Outcomes (1)

• Presence of SARS-CoV-2 RNA in the olfactory mucosa

  Comparison of the presence of SARS-CoV-2 RNA in the olfactory mucosa between cases and controls

  Inclusion

Study Arms (2)

Case : patient with 1st episode of COVID-19 and persistence of neurocognitive complaint

OTHER

Patient with a 1st episode of COVID-19 in the 12 months preceding inclusion and presenting persistence of neurocognitive complaint beyond 4 weeks

Biological: Nasopharyngeal swab for RT-PCR SARS-CoV-2

Control : Patient with a 1st episode of COVID-19 cured and without neurocognitive complaint

OTHER

Patient with a cured 1st episode of COVID-19 (without persisting symptoms beyond 4 weeks) in the 12 months preceding inclusion and without neurocognitive complaint

Biological: Nasopharyngeal swab for RT-PCR SARS-CoV-2

Interventions

Nasopharyngeal swab for RT-PCR SARS-CoV-2 BIOLOGICAL

2 nasal swabs (one per nostril) of olfactory mucosa cells under local anesthesia for SARS-CoV-2 RT-PCR and pathological analysis

Also known as: Blood sample for SARS-CoV-2 serology, MoCA (Control only), Ask the 3 questions from the Catherine Thomas-Antérion scale to search for a neurocognitive complaint (Control only)

Case : patient with 1st episode of COVID-19 and persistence of neurocognitive complaint; Control : Patient with a 1st episode of COVID-19 cured and without neurocognitive complaint

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hotel Dieu Hospital: collaborator
• Institut Pasteur: collaborator
• Hôpital Lariboisière Fernand Widal: collaborator
• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (2)

Hôpital Lariboisière-Fernand-Widal

Paris, 75010, France

Location

Hôpital Fondation A. de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

COVID-19; Cognitive Dysfunction

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mathieu Veyrat, Dr

  Hôpital Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 2, 2022
• Study Start: July 1, 2022
• Primary Completion: June 20, 2025
• Study Completion: July 10, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

FR (2)