NCT04427254

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

June 26, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

2.4 years

First QC Date

May 26, 2020

Last Update Submit

July 10, 2023

Conditions

COVID19

Keywords

Sars-Cov2 neuroinvasivenessCOVID-19 RT-PCR test

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with COVID-19 positive samples/biopsies

    COVID-19 RT-PCR test

    At the time of the inclusion

Study Arms (1)

Neurological biological samples

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

Interventions

Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsiesDRUG

Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies

Neurological biological samples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pierre BOURDILLON, MD

    Fondation A. de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 11, 2020

Study Start

June 26, 2020

Primary Completion

November 25, 2022

Study Completion

November 25, 2022

Last Updated

July 11, 2023

Record last verified: 2023-07

Locations

FR(1)