WHO Covid 19 - Neurological Abnormalities in SARS-CoV-2 ICU Patients (NeuroCovid)

Neurological Abnormalities in SARS-CoV-2 ICU Patients. A Prospective Study. NeuroCOVID Study

The SARS-CoV-2 epidemic is leading to a large number of patients in intensive care units due to severe hypoxemic pneumonia. After an acute phase that may require controlled mechanical ventilation and deep sedation, removal of sedation often reveals a pathological awakening in the vast majority of patients. This encephalopathy state remains, to date and to our knowledge, unexplained. Clinical features do not appear to fully correlate with regular delirium. This encephalopathy might be explained by deep and prolonged hypoxemia, a wide use of sedation drugs, systemic inflammation or the hostile ICU environment.

Study Overview

• Status: Unknown
• Conditions: Delirium; SARS-CoV-2 Infection; Encephalopathy; Intensive Care Unit Patient; Neurological Abnormality

Detailed Description

This study is intended to investigate neurological abnormalities associated with SARS-CoV-2 infection. Complete daily neurological examinations will be routinely conducted in intensive care unit patients. Specific biological analyses will also be performed in these patients by collecting additional blood samples from an arterial or central catheter, every 2 days. These clinical and biological examinations will be continued throughout patient's stay in the intensive care unit.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: +33 4 754 963; Email: llaclautre_perrier@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU
    • Contact: Benjamin Rieu; Email: brieu@chu-clermontferrand.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in Intensive Care Unit and infected bye SARS-CoV-2

Description

Inclusion Criteria:

• Age ≥ 18 years old
• COVID-19 positive patient (positive RT PCR, nasopharyngeal or tracheal)
• Patient admitted in an intensive care unit of the department of Anesthesia, Critical Care and Perioperative of Clermont-Ferrand University Hospital
• Patient with an arterial or central catheter to perform blood samples collection

Exclusion Criteria:

• Patient or family member's refusal to participate
• Neuropsychiatric history that may interfere with neurological evaluations in the intensive care unit
• Patient not affiliated with French social security insurance
• Patient under legal guardianship

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage of biomarkers typically explored in intensive care unit delirium	Plasminogen activator inhibitor-1 (PAI-1), E-selectin and angiopoietin-2	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 days
Dosage of neuronal injury markers	S100 β, Neuron Specific Enolase (NSE), GFAP, UCHL1, NFL	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium assessment	CAM-ICU (Confusion Assessment Method - Intensive Care Unit) scale	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Delirium assessment	ICDSC (Intensive Care Delirium Screening Checklist) scale.	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Coma assessment	CRS-R (Coma Recovery Scale-Revised)	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Pupils characteristics	Clinical observation	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Pupils characteristics	Pupilometer assessment	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Neurological abnormalities	Electroencephalogram : epileptic activity (spikes, spike-waves) or encephalopathy activity (triphasic waves))	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Neurological abnormalities	CT-scan	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Neurological abnormalities	MRI	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 13, 2020
• Primary Completion (ANTICIPATED): June 13, 2021
• Study Completion (ANTICIPATED): August 13, 2021

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (ACTUAL): November 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 28, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2 infection; Delirium; Encephalopathy; Intensive care unit patient; Neurological abnormalities
• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; COVID-19; Delirium; Congenital Abnormalities; Brain Diseases; Nervous System Malformations
• Other Study ID Numbers: NeuroCovid-RNI 2020 GODET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No