Study of Neurological Damage From Coronavirus Disease (CO... | NCT05079373

Studies
Study of Neurological Damage From Coronavirus Disease (COVID-19)

NCT05079373

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Nov 30, 2021Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

Oct 9, 2022Estimated

Completion Date

Oct 31, 2022Estimated

First Submitted Date

Oct 13, 2021

First Submission Date that Met QC Criteria

Oct 13, 2021

First Posted Date

Oct 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2021

Last Update Posted Date

Nov 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to support the exploration of the NEURO-COVID-19 database and in particular to carry out the post-treatments necessary to derive quantitative information on the characterization of the lesion load, in particular with regard to of the vascular tree

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective study of the neurological damage in patients with Covid-19		Files analysed retrospectively from January 01, 2020 to October 31, 2021 will be examined]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Adult patient (≥18 years old)
COVID + patient presenting with neurological symptoms leading to an MRI.
Patient taken care of in one of the care centers associated with this research
Patient not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

Patient who expressed his opposition to participating in the study
COVID patient not having neurological symptoms or not having received an MRI
Patient under guardianship or guardianship
Patient under legal protection

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patient having covid and presenting with neurological symptoms leading to an MRI.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stephane Kremer, MD, PhD	Contact	33 3 88 12 78 89		stephane.kremer@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR	Contact			said.chayer@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Imagerie 2 - Neuroradiologie et Radiologie Ostéo-articulaire - Hôpitaux Universitaires de Strasbourg	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D006261	Headache
D000086582	Anosmia
D003128	Coma

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided