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2020 ; 33
(1
): 25-34
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Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID):
Study Design and Rationale
#MMPMID32445105
Frontera J
; Mainali S
; Fink EL
; Robertson CL
; Schober M
; Ziai W
; Menon D
; Kochanek PM
; Suarez JI
; Helbok R
; McNett M
; Chou SH
Neurocrit Care
2020[Aug]; 33
(1
): 25-34
PMID32445105
show ga
BACKGROUND: As the COVID-19 pandemic developed, reports of neurological
dysfunctions spanning the central and peripheral nervous systems have emerged.
The spectrum of acute neurological dysfunctions may implicate direct viral
invasion, para-infectious complications, neurological manifestations of systemic
diseases, or co-incident neurological dysfunction in the context of high
SARS-CoV-2 prevalence. A rapid and pragmatic approach to understanding the
prevalence, phenotypes, pathophysiology and prognostic implications of COVID-19
neurological syndromes is urgently needed. METHODS: The Global Consortium to
Study Neurological dysfunction in COVID-19 (GCS-NeuroCOVID), endorsed by the
Neurocritical Care Society (NCS), was rapidly established to address this need in
a tiered approach. Tier-1 consists of focused, pragmatic, low-cost, observational
common data element (CDE) collection, which can be launched immediately at many
sites in the first phase of this pandemic and is designed for expedited ethical
board review with waiver-of-consent. Tier 2 consists of prospective functional
and cognitive outcomes assessments with more detailed clinical, laboratory and
radiographic data collection that would require informed consent. Tier 3 overlays
Tiers 1 and 2 with experimental molecular, electrophysiology, pathology and
imaging studies with longitudinal outcomes assessment and would require centers
with specific resources. A multicenter pediatrics core has developed and launched
a parallel study focusing on patients ages <18 years. Study sites are eligible
for participation if they provide clinical care to COVID-19 patients and are able
to conduct patient-oriented research under approval of an internal or global
ethics committee. Hospitalized pediatric and adult patients with SARS-CoV-2 and
with acute neurological signs or symptoms are eligible to participate. The
primary study outcome is the overall prevalence of neurological complications
among hospitalized COVID-19 patients, which will be calculated by pooled
estimates of each neurological finding divided by the average census of COVID-19
positive patients over the study period. Secondary outcomes include: in-hospital,
30 and 90-day morality, discharge modified Rankin score, ventilator-free
survival, ventilator days, discharge disposition, and hospital length of stay.
RESULTS: In a one-month period (3/27/20-4/27/20) the GCS-NeuroCOVID consortium
was able to recruit 71 adult study sites, representing 17 countries and 5
continents and 34 pediatrics study sites. CONCLUSIONS: This is one of the first
large-scale global research collaboratives urgently assembled to evaluate acute
neurological events in the context of a pandemic. The innovative and pragmatic
tiered study approach has allowed for rapid recruitment and activation of
numerous sites across the world-an approach essential to capture real-time
critical neurological data to inform treatment strategies in this pandemic
crisis.
free
free
free
