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

Neurologic Complication Clinical Trial

— Neuro-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418609
• Other study ID #: Neuro-COVID-19
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: June 9, 2022

Study information

• Verified date: August 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Neurologic Complication

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Emanuela Keller

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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