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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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SARS-CoV-2 Infection, Intensive Care Unit Patient, Neurological Abnormality, Delirium, Encephalopathy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2 infection, Intensive care unit patient, Neurological abnormalities, Delirium, Encephalopathy