Study of the Sars-Cov2 Neuroinvasiveness - COVID19

Not Applicable

Terminated

• Conditions: COVID19
• Interventions: Drug: Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies

• Registration Number: NCT04427254
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Sars-Cov2 (COVID-19) may invade the CNS inducing neurological diseases such as anosmia, ageusia, encephalitis, ischemic or hemorrhagic stroke. Management of severe neurological complications in COVID-19 patients may require ventricular cerebrospinal fluid drainage and cranial decompression. During surgery, cerebrospinal fluid, meninges and brain parenchyma can be safely removed from the patient. In this study, COVID-19 patients will be evaluated first, for the presence of Sars-Cov2 in the cerebrospinal fluid and/or biopsies and second, for the consequences of Sars-Cov2 neuroinfection in terms of inflammatory and immune responses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-11
• Study Start: 2020-06-26
• Primary Completion: 2022-11-25
• Study Completion: 2022-11-25
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• COVID-19 patients requiring an external ventricular drain, a decompressive craniectomy or an intracranial hematoma surgery

Exclusion Criteria

• Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurological biological samples	Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with COVID-19 positive samples/biopsies	At the time of the inclusion	COVID-19 RT-PCR test

Trial Locations

Locations (1)

Fondation A de Rothschild; 🇫🇷 Paris, France