NCT04460599

Brief Summary

Description of the neurological impairment: clinico-radiological and electrophysilogical correlations

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 8, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 6, 2020

Last Update Submit

July 7, 2020

Conditions

Encephalitis

Keywords

Cranial nervesbrainstemdysautonomia

Outcome Measures

Primary Outcomes (1)

  • Primary

    incidence of objective neurological damage

    6 months

Secondary Outcomes (1)

  • Secondary

    6 months

Interventions

ObservationOTHER

Observation of recorded neurological signs

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population hospitalized in ICU for COVID 19.

You may qualify if:

  • PCR SARS COV2 positive or CT Scan
  • Central neurological signs such as confusion, epilepsy, abnormal movement, pyramidal signs, motor or sensory deficit, involvement of cranial pairs (such as anomie or ageusia) or peripheral.
  • Dysautonomic signs such as hypotension or hypertension, bradycardia or tachycardia, hypothermia, SIADH not explained by therapy or a pathology other than SARS COV 2 infection

You may not qualify if:

  • Contraindication to performing an MRI scan
  • Minor
  • Pregnant woman
  • No follow-up possible at 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincare

Garches, 92380, France

RECRUITING

MeSH Terms

Conditions

EncephalitisAutonomic Nervous System Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

David Orlikowski, MD PhD

CONTACT

0147107777david.orlikowski@aphp.fr

Isabelle Bossard

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 7, 2020

Study Start

March 8, 2020

Primary Completion

July 30, 2020

Study Completion

September 30, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)