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

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

• Registration Number: NCT04643548
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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

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 Timeline

• Study Start: 2020-10-13
• Status Verified: 2020-11
• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-11-25
• Last Update Submitted: 2020-11-28
• Last Update Posted: 2020-12-01
• Primary Completion: 2021-06-13
• Study Completion: 2021-08-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Delirium assessment	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days	ICDSC (Intensive Care Delirium Screening Checklist) scale.
Coma assessment	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days	CRS-R (Coma Recovery Scale-Revised)
Neurological abnormalities	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days	MRI
Pupils characteristics	Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days	Pupilometer assessment

Trial Locations

Locations (1)

CHU; 🇫🇷 Clermont-Ferrand, France