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Neurological Features During COVID19 (NeuroSARS)

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ClinicalTrials.gov Identifier: NCT04460599
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
david orlikowski, Centre d'Investigation Clinique et Technologique 805

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

Condition or disease Intervention/treatment
Encephalitis Other: Observation

Detailed Description:
Describe short and long term clinical radiological and electrophysilogical presentations of neurological damage central and peripheral SARS COV2 infection Describe the association between neurological, respiratory and dysautonomic Determine the prognosis of neurological damages to short and long term.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Description of neurolOgical Involvement Observed During SARS COV2 Infection
Actual Study Start Date : March 8, 2020
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis


Intervention Details:
  • Other: Observation
    Observation of recorded neurological signs


Primary Outcome Measures :
  1. Primary [ Time Frame: 6 months ]
    incidence of objective neurological damage


Secondary Outcome Measures :
  1. Secondary [ Time Frame: 6 months ]
    incidence of clinical neurological damage incidence of radiological neurological damage incidence of neurophysiological neurological damage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Population hospitalized in ICU for COVID 19.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460599


Contacts
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Contact: David Orlikowski, MD PhD 0147107777 david.orlikowski@aphp.fr
Contact: Isabelle Bossard

Locations
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France
Hopital Raymond Poincare Recruiting
Garches, France, 92380
Contact: DAVID ORLIKOWSKI, MD PHD    (33)147107777    david.orlikowski@rpc.aphp.fr   
Contact    (33)147104469      
Principal Investigator: DAVID ORLIKOWSKI, MD PHD         
Sub-Investigator: Eric Azabou, MD         
Sub-Investigator: Marie Christine Durand, MD         
Sub-Investigator: Robert Carlier, MD PHD         
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
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Responsible Party: david orlikowski, Professor, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT04460599    
Other Study ID Numbers: Brain COVID
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by david orlikowski, Centre d'Investigation Clinique et Technologique 805:
Cranial nerves
brainstem
dysautonomia
Additional relevant MeSH terms:
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Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases