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

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.

Study Overview

• Status: Completed
• Conditions: Neurologic Complication
• Intervention / Treatment: Other: further processing of health data

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 Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to the Intensive Care Units (ICUs) of the Institute of Intensive Care Medicine, University Hospital of Zurich meeting eligibility criteria during the pandemic will be enrolled.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of neurological complications	Determine the prevalence of neurological complications in hospitalized COVID-19 patients admitted to the intensive care unit.	through study completion, on an average of 3 weeks
Prevalence and outcome of severe neurological complications	Examine if empiric COVID-19 therapies are associated with difference in the prevalence and outcome of severe neurological complications of COVID-19.	through study completion, on an average of 3 weeks
Impact of neurological complications	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.	through study completion, on an average of 3 weeks
Characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF)	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	through study completion, on an average of 3 weeks
Brain for pathological changes and histopathological findings (if patient dies).	Analyze the brain for pathological changes and histopathological findings, if the patient dies.	through study completion, on an average of 3 weeks

Collaborators and Investigators

• Sponsor: Emanuela Keller
• Investigators: Principal Investigator: Emanuela Keller, Prof. Dr., University Hospital, Zürich

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): June 9, 2022
• Study Completion (Actual): June 9, 2022

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Neuro-Covid-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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