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NCT04427254 Clinical Trial

Study of the Sars-Cov2 Neuroinvasiveness - COVID19

COVID19 Clinical Trial

— CORONEVRAXE  

Official title:
Study of the Sars-Cov2 Neuroinvasiveness - COVID19

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04427254
Other study ID # PBN_2020_16
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 26, 2020
Est. completion date November 25, 2022

Study information
Verified date July 2023
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date November 25, 2022
Est. primary completion date November 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Fondation A de Rothschild Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with COVID-19 positive samples/biopsies COVID-19 RT-PCR test At the time of the inclusion
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