NCT04361344

Brief Summary

Emergence of Covid-19 virus is associated with high frequency of extremely severe clinical pictures, with minor signs of CNS impairment (e.g. anosmia, headache). Since neurotropism is a common feature of coronavirus infection in animals, the investigators examine if indirect signs of CNS lesion are observed in association with severe Covid-19 infection.

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

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

May 19, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2020

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

April 16, 2020

Last Update Submit

February 2, 2021

Conditions

COVID-19 InfectionEncephalitis

Keywords

COVID-19encephalitisbiomarkersneurofilament protein lightGFAP protein

Outcome Measures

Primary Outcomes (1)

  • Change of neurodegeneration markers level

    Change of neurofilament light chain (NFL) (pg/ml) level between first day of hospitalisation and one week; and change of GFAP (pg/ml) level between first day of hospitalisation and one week.

    Level of neurofilament light chain (NFL) is dosed at inclusion (day 0) and week 1. Level of GFAP is dosed at inclusion (day 0) and week 1 (day 7).

Interventions

blood samplesBIOLOGICAL

Clinical examination and blood samples will be done at inclusion (day 0), at day 7 (between day 4 and exit from intensive care) and at day 60.

Eligibility Criteria

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

You may qualify if:

  • Infection with Covid-19 (proven or probable) AND
  • possible encephalitis (at least confusion, epilepsy) OR
  • clinical severity requiring invasive ventilation.

You may not qualify if:

  • brain stroke
  • minor CNS dysfunction (isolated smell loss or headache),
  • absence of Covid infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH de Pau

Pau, 64046, France

Location

MeSH Terms

Conditions

COVID-19Encephalitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective, descriptive, monocentric, non-controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 24, 2020

Study Start

May 19, 2020

Primary Completion

October 25, 2020

Study Completion

October 25, 2020

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

FR(1)