COVID-19 Neurological Disease: A Prospective Study in Brazil, India and Malawi
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,017
- 试验地点
- 5
- 主要终点
- Acute new-onset neurological disease
研究概览
简要总结
Background: Recent reports increasingly recognize neurological manifestations in COVID-19 patients. However, the full spectrum of the disease and risk factors are not well understood.
Aim: To describe the full spectrum of neurological manifestations in COVID-19 and assess the clinical characteristics, risks and prognostic factors.
Outcomes: Identification of COVID-19 associated neurological disease is the primary outcome while requirement for admission to critical care unit, mortality, length of hospital stay, quality of life, and neurological disability are the secondary outcomes.
Participants: Patients above Age more than 18 years enrolled based on new-onset acute neurological disease and COVID19 positive will serve as cases while patient with confirmed COVID-19 without neurological manifestation will serve as controls.
Design and Procedures: The study is prospective case control in design and is divided into three phases in India, Brazil and Malawi ; the first phase will address role of hypoxia in causation of neurological diseases, the second phase will compare characteristics of patients hospitalized with COVID-19 with and without neurological disease and the third phase will assess the long-term follow up (at 3 months and 9 months) of cases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Acute new-onset neurological disease
时间窗: Day 30 of admission, or at discharge, or at death, whichever is earlier
次要结局
- Admission to a critical (intensive/high dependency) care unit(Day 30 of admission, or at discharge, or at death, whichever is earlier)
- Time to discharge from hospital(Day 30 of admission, or at discharge, or at death, whichever is earlier)
- Modified Rankin Score(Discharge (or day 30), 3 months and 9 months)
- Montreal Cognitive Assessment (MoCA)(Discharge (or day 30), 3 months and 9 months)
- European QoL-5D (EQ-5D-3L) overall health utility quality of life score(Discharge (or day 30), 3 months and 9 months)
- Glasgow Outcome Scale Extended(Discharge (or day 30), 3 months and 9 months)
- Severity of stroke using National Institutes of Health Stroke Scale (NIHSS)(Day 30 of admission, or at discharge, or at death, whichever is earlier)
- Development of new onset neurological sequelae(Discharge (or day 30), 3 months and 9 months)
- Death(In-hospital (up to 30 days from admission), and at 3 months and 9 months)