Clinical trial NCT04418609: Neuro-COVID-19: Neurological Complications of COVID-19
Official title: Neuro-COVID-19: Neurological Complications of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurologic Complication
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of neurological complications
timeFrame: through study completion, on an average of 3 weeks
measure: Prevalence and outcome of severe neurological complications
timeFrame: through study completion, on an average of 3 weeks
measure: Impact of neurological complications
timeFrame: through study completion, on an average of 3 weeks
measure: Characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF)
timeFrame: through study completion, on an average of 3 weeks
measure: Brain for pathological changes and histopathological findings (if patient dies).
timeFrame: through study completion, on an average of 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospital, Zürich
name: Emanuela Keller, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: