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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neurologic Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

further processing of health data

Other

further processing of biological materials and health related personal data for research

Other names: further processing of biological materials and health related personal data

Primary outcomes

Prevalence of neurological complications

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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).

Time frame: through study completion, on an average of 3 weeks

Analyze the brain for pathological changes and histopathological findings, if the patient dies.

Sponsors and collaborators

Lead sponsor

Emanuela Keller

Other

Registry information

Acronym: Neuro-COVID

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Jun 5, 2020
Registry last updated: Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed