Neuro-COVID-19: Neurological Complications of COVID-19

Completed

• Conditions: Neurologic Complication

• Registration Number: NCT04418609
• Lead Sponsor: Emanuela Keller

Brief Summary

The prevalence and typical patterns of neurological complications in hospitalized COVID-19 patients admitted to the intensive care units of the University Hospital Zurich will be investigated. The impact of neurological complications among COVID-19 patients on mortality, functional outcome, and organizational outcomes will be analyzed.

Detailed Description

This study is a prospective observational cohort study to document prevalence and severity of neurological symptoms among patients requiring critical care admission for confirmed novel coronavirus disease (COVID-19). COVID-19 is classified as severe acute respiratory syndrome 2 (SARS-CoV-2) and shares significant structural and biological similarities with SARS-CoV, which has neuroinvasive properties and brainstem involvement. Early reports of COVID-19 progression indicate presence of severe neurological complications, including seizures, coma, encephalitis, and cerebrovascular events including ischemic stroke, intracranial hemorrhage, and cerebral venous sinus thromboses. In addition, recent data from Zika-virus and H1N1 influenza pandemics reveal a high incidence of neurological complications, including Guillain Barré syndrome and neonatal microcephaly for Zika-virus and narcolepsy with H1N1 infections. Early reports from China suggest neurological symptoms may occur in approximately 36% of SARS-CoV-2 positive patients, with increased prevalence among more severe cases, and fall into three categories: central nervous system symptoms or diseases, peripheral nervous system symptoms, and skeletal muscular symptoms. However, the exact prevalence of these conditions and impact on patient disease severity and outcomes is unknown. As the incidence and severity of COVID-19 infection continues to rapidly rise on an international level, it is imperative to capture prospective data to accurately document prevalence, severity and clinical characterization of neurological components of COVID-19, the influence of treatment regimens of neurological complications, and role of these confounders on patient and organizational outcomes.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-05
• Primary Completion: 2022-06-09
• Study Completion: 2022-06-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Adults (age > 18 years old) treated at ICUs
• Admitted with confirmed COVID-19 infection
• Patient exhibiting acute neurological manifestations
• General consent of the Institute of Intensive Care Medicine available from patient or legal representative

Exclusion Criteria

• Pre-existing severe neurologic dysfunction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of neurological complications	through study completion, on an average of 3 weeks	Determine the prevalence of neurological complications in hospitalized COVID-19 patients admitted to the intensive care unit.
Prevalence and outcome of severe neurological complications	through study completion, on an average of 3 weeks	Examine if empiric COVID-19 therapies are associated with difference in the prevalence and outcome of severe neurological complications of COVID-19.
Impact of neurological complications	through study completion, on an average of 3 weeks	Determine the impact of neurological complications among COVID-19 patients on mortality, functional outcome, and organizational outcomes (ICU length of stay, hospital length of stay) among patients with confirmed COVID-19.
Characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF)	through study completion, on an average of 3 weeks	Analyze characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF) of patients, in whom a lumbar puncture has been performed for clinical reasons
Brain for pathological changes and histopathological findings (if patient dies).	through study completion, on an average of 3 weeks	Analyze the brain for pathological changes and histopathological findings, if the patient dies.

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zürich, Switzerland