Clinical trial

Study of the Sars-Cov2 Neuroinvasiveness - COVID19

Name

PBN_2020_16

Description

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.

Trial arms

Trial start

2020-06-26

Estimated PCD

2022-11-25

Trial end

2022-11-25

Status

Terminated

Treatment

Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies

Arms:

Neurological biological samples

Size

Primary endpoint

Percentage of patients with COVID-19 positive samples/biopsies

At the time of the inclusion

Eligibility criteria

Inclusion Criteria: * COVID-19 patients requiring an external ventricular drain, a decompressive craniectomy or an intracranial hematoma surgery Exclusion Criteria: * Pregnant or lactating women

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2, 'type': 'ACTUAL'}}

Updated at

2023-07-11

1 organization

1 product

1 indication

Organization

Fondation Ophtalmologique Adolphe de Rothschild

Product

Cerebrospinal fluid sampling

Indication

COVID-19