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.

中文翻译：

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COVID-19 神经功能障碍全球联盟研究 (GCS-NeuroCOVID)：研究设计和基本原理。

背景 随着 COVID-19 大流行的发展，出现了跨越中枢和外周神经系统的神经功能障碍的报道。在 SARS-CoV-2 高流行的背景下，急性神经功能障碍的范围可能与病毒直接入侵、副感染并发症、全身性疾病的神经系统表现或同时发生的神经功能障碍有关。迫切需要一种快速而实用的方法来了解 COVID-19 神经系统综合征的患病率、表型、病理生理学和预后影响。方法 由神经重症监护协会 (NCS) 批准的 COVID-19 神经功能障碍研究全球联盟 (GCS-NeuroCOVID) 迅速成立，以分层方法解决这一需求。Tier-1 包括专注、务实、低成本、观察性通用数据元素 (CDE) 收集，可在本次大流行的第一阶段在许多地点立即启动，旨在加快伦理委员会审查并放弃同意。第 2 层包括前瞻性功能和认知结果评估，以及需要知情同意的更详细的临床、实验室和放射学数据收集。第 3 层将第 1 层和第 2 层与具有纵向结果评估的实验性分子、电生理学、病理学和影像学研究相重叠，并且需要具有特定资源的中心。一个多中心儿科核心已经开发并启动了一项针对年龄 <18 岁患者的平行研究。如果研究地点为 COVID-19 患者提供临床护理，并且能够在内部或全球伦理委员会的批准下进行以患者为导向的研究，则他们有资格参与。患有 SARS-CoV-2 并伴有急性神经系统体征或症状的住院儿科和成人患者有资格参加。主要研究结果是住院 COVID-19 患者中神经系统并发症的总体患病率，其计算方法是将每个神经系统发现的汇总估计值除以研究期间 COVID-19 阳性患者的平均人口普查。次要结局包括：住院、30 天和 90 天道德、出院修正 Rankin 评分、无呼吸机生存、呼吸机天数、出院处置和住院时间。结果 在一个月的时间里（3/27/20-4/27/20），GCS-NeuroCOVID 联盟能够招募 71 个成人研究地点，代表 17 个国家和 5 个大洲和 34 个儿科研究地点。结论 这是为评估大流行背景下的急性神经系统事件而紧急组建的首批大规模全球研究合作组织之一。创新和务实的分层研究方法允许快速招募和激活世界各地的众多地点——这是一种获取实时关键神经学数据以便为这场大流行危机中的治疗策略提供信息的必要方法。结论 这是为评估大流行背景下的急性神经系统事件而紧急组建的首批大规模全球研究合作组织之一。创新和务实的分层研究方法允许快速招募和激活世界各地的众多地点——这是一种获取实时关键神经学数据以便为这场大流行危机中的治疗策略提供信息的必要方法。结论 这是为评估大流行背景下的急性神经系统事件而紧急组建的首批大规模全球研究合作组织之一。创新和务实的分层研究方法允许快速招募和激活世界各地的众多地点——这是一种获取实时关键神经学数据以便为这场大流行危机中的治疗策略提供信息的必要方法。