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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04643548
Acronym
NeuroCovid
Enrollment
20
Registered
2020-11-25
Start date
2020-10-13
Completion date
2021-08-13
Last updated
2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

SARS-CoV-2 infection, Intensive care unit patient, Neurological abnormalities, Delirium, Encephalopathy

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.

Interventions

None listed

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Dosage of biomarkers typically explored in intensive care unit deliriumChange from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 daysPlasminogen activator inhibitor-1 (PAI-1), E-selectin and angiopoietin-2
Dosage of neuronal injury markersChange from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 daysS100 β, Neuron Specific Enolase (NSE), GFAP, UCHL1, NFL

Secondary

MeasureTime frameDescription
Delirium assessmentChange from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every daysCAM-ICU (Confusion Assessment Method - Intensive Care Unit) scale
Coma assessmentChange from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every daysCRS-R (Coma Recovery Scale-Revised)
Pupils characteristicsChange from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every daysClinical observation
Neurological abnormalitiesChange from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every daysElectroencephalogram : epileptic activity (spikes, spike-waves) or encephalopathy activity (triphasic waves))

Countries

France

Contacts

Primary ContactLise Laclautre
llaclautre_perrier@chu-clermontferrand.fr+33 4 754 963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026