NCT04555148已完成2 期
A Prospective, Open-label, Randomized, Multi-center, Phase 2a Study to Evaluation the Dose Response, Efficacy and Safety of Hyper-Ig (Hyper-immunoglobulin) GC5131 in Patients With COVID-19
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Ordinal scale outcome
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The COVID-19 patient who diagnosed by PCR within 3 days prior to randomized And who is hospitalized with COVID-19 related symptoms
- •The subject who has symptoms of COVID-19 within 7 days
- •The subject with pneumonia confirmed by imaging diagnosis related to COVID-19 OR a 70-year-old or older OR 60-year-old or older with underlying disease (diabetes or hypertension or obesity or smoker)
- •Willing and able to provide written informed consent prior to performing study procedures
排除标准
- •asymptomatic patient
- •The subject who requiring mechanical ventilation or ECMO
- •The subject who are underlying oxygen therapy before affected by COVID-19
- •The subject who have received antiviral drugs for other disease within 4 weeks
- •History of allergy to IVIG or plasma products
- •The subject who received IVIG or convalescent plasma from a person who recovered from COVID-19
- •IgA deficiency
- •Cretinine > 2 X ULN
- •The subject with a history of thrombosis or high risk of thromboembolism
- •The subject with reduced heart function [NYHA (New York Heart Association) Functional Class III or IV]; or cerebral cardiovascular disorder or a patient with the medical history (ischemic disease, cardiovascular disease, cerebrovascular disorder, blood vessel disorder, etc.)
结局指标
主要结局
Ordinal scale outcome
时间窗: 7, 14, 21, 28 days
The percent of participants changed by 2 points or more
次要结局
- Change in NEWS2 (National Early Warning Score 2)(7, 14, 21, 28 days)
- Viral negative(1, 3, 5, 7, 10 days)
- mortality(28 days)
研究者
研究点 (1)
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