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临床试验/NCT04496128
NCT04496128已完成不适用

Neurological Complications of COVID-19

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年4月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Global functional outcomes using modified Rankin score

研究概览

简要总结

This study is a prospective observational cohort study to document the prevalence and types of neurological manifestations among hospitalized patients with confirmed or suspected novel coronavirus infection (COVID-19).

详细描述

This study is a prospective observational cohort study to document the prevalence and types of neurological manifestations among hospitalized patients with confirmed or suspected novel coronavirus infection (COVID-19). Severe acute respiratory syndrome 2 (SARS-CoV-2), the virus that causes COVID-19, shares significant structural and biological similarities with SARS-CoV, which is known to be neuroinvasive particularly with brainstem involvement. There are emerging reports of neurological symptoms associated with COVID-19 infections, including seizures, coma, encephalitis, Guillan-Barre syndrome, and cerebrovascular events including ischemic stroke, ICH, and cerebral venous sinus thromboses. However, the exact prevalence of these conditions and their impact on patient disease severity and outcomes is unknown. As the incidence and severity of COVID-19 infection continue to rapidly rise globally, 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients greater than or equal to 18 years old
  • Admitted with suspected or confirmed COVID19 infection
  • Patient exhibiting acute neurological symptoms

排除标准

  • Patients under the age of 18 years old
  • Pre-existing, baseline severe neurologic dysfunction including baseline coma/vegetative state, baseline quadriparesis, baseline refractory seizure disorder with frequent breakthrough seizures despite anticonvulsant use

结局指标

主要结局

Global functional outcomes using modified Rankin score

时间窗: At hospital discharge, approximately 1 month

Patients will be assessed on a scale score of 0 (no symptoms at all) to 5 (severe disability; bedridden, incontinent and requiring constant nursing care and attention)

Prevalence of neurological manifestations

时间窗: During hospital course, up to 1 month

Proportion of patients with neurological symptoms out of all hospitalized COVID19 patients during study period.

Hospital Mortality

时间窗: At hospital discharge, approximately 1 month

次要结局

  • Length of ICU stay(At hospital discharge, approximately 1 month)
  • 30-day mortality(30 days from the first day of hospitalization)
  • Length of hospital stay (in days)(At hospital discharge, approximately 1 month)
  • 90-day mortality(90 days from the first day of hospitalization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherry Hsiang-Yi Chou

Associate Professor

University of Pittsburgh

研究点 (1)

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