Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Study Design and Rationale

the GCS-NeuroCOVID Study

Research output: Contribution to journalArticlepeer-review

49 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)25-34
Number of pages10
JournalNeurocritical Care
Volume33
Issue number1
DOIs
StatePublished - Aug 1 2020

Funding

R21NS113037 (Chou), the University of Pittsburgh Dean’s Faculty Advancement Award (Chou), Clinical and Translational Science Institute, University of Pittsburgh (Chou). Dr. Chou reports grant funding from the National Institutes of Health. Dr. Ziai reports grant funding from the National Institutes of Health, and personal fees from CR Bard and Portola outside the submitted work. Dr. Fink reports grant funding from The National Institute of Health. Dr. Helbok reports personal fees from BARD Medical, Zoll Medical Corporation, and Integra Lifesciences outside the submitted work. The remaining authors have nothing to disclose. The authors would like to thank the Adult Study Coordinator Team: Michal Hammond, MD; Valeria Altamirano, BS, MS; Carlos Villamizar-Rosales, MD; Ali Smith; Lauren E. Kaplan, BS; Nicole Paul, BS; Charith Ratnayake, BS; Aditya D. Sharma from the University of Pittsburg and Haley Roberts, BS from The Ohio State University. We also thank the Pediatric Study Coordinator Team: Pamela Rubin, RN and David Maloney, BS from the Department of Critical Care Medicine, UPMC Children’s Hospital of Pittsburgh, and Pediatric Neurointensivists: Dennis Simon, MD from the Department of Critical Care Medicine, UPMC Children’s Hospital of Pittsburgh, Elizabeth Wells, MD, MHS from the Division of Neurology, Children’s National Hospital, Washington, D.C., Juan Piantino MD Division of Neurology, The Oregon Health and Science University, and Andrew Geneslaw, MD, Department of Pediatrics, Morgan Stanley Children’s Hospital. The authors gratefully acknowledge the support from the Neurocritical Care Research Central and The Neurocritical Care Research Network of the Neurocritical Care Society. The authors would like to thank the Adult Study Coordinator Team: Michal Hammond, MD; Valeria Altamirano, BS, MS; Carlos Villamizar-Rosales, MD; Ali Smith; Lauren E. Kaplan, BS; Nicole Paul, BS; Charith Ratnayake, BS; Aditya D. Sharma from the University of Pittsburgh and Haley Roberts, BS from The Ohio State University. We also thank the Pediatric Study Coordinator Team: Pamela Rubin, RN and David Maloney, BS from the Department of Critical Care Medicine, UPMC Children’s Hospital of Pittsburgh, and Pediatric Neurointensivists: Dennis Simon, MD from the Department of Critical Care Medicine, UPMC Children’s Hospital of Pittsburgh, Elizabeth Wells, MD, MHS from the Division of Neurology, Children’s National Hospital, Washington, D.C., Juan Piantino MD Division of Neurology, The Oregon Health and Science University, and Andrew Geneslaw, MD, Department of Pediatrics, Morgan Stanley Children’s Hospital. The authors gratefully acknowledge the support from the Neurocritical Care Research Central and The Neurocritical Care Research Network of the Neurocritical Care Society. This study is partially funded by a grant from the Clinical Translational Science Institute COVID 19 Pilot Award from the University of Pittsburg. Acknowledgements

Keywords

  • COVID-19
  • Coronavirus
  • Neurological manifestations
  • Neurological symptoms
  • SARS-CoV-2

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine
  • Clinical Neurology

Fingerprint

Dive into the research topics of 'Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Study Design and Rationale'. Together they form a unique fingerprint.

Cite this