A Randomized, Open-label, Controlled, Single-center Study to Evaluate the Efficacy of Intravenous Immunoglobulin Therapy in Patients With Severe 2019- nCoV Pneumonia
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 主要终点
- Lower Murray lung injury score
研究概览
简要总结
In this single-center, randomized, open-label, controlled study, the investigators will evaluate the efficacy and safety of Intravenous Immunoglobulin (IVIG) in combination with standard care for severe 2019 novel coronavirus (2019-nCoV) pneumonia.
详细描述
In December 2019, viral pneumonia caused by a novel beta-coronavirus (2019-nCoV) outbroke in Wuhan, China. Part of patients rapidly progress severe acute respiratory failure with substantial mortality, making it imperative to develop an efficient treatment for severe 2019-nCoV pneumonia besides the supportive care.
Intravenous immunoglobulin (IVIG) has been shown to improve the treatment effect and prognosis of severe infection over the past decades with its capacity of proving passive immunity and anti-inflammatory, immunomodulatory effect. We hypothesized that IVIG therapy would improve the prognosis of severe and critically ill patients with 2019-nCoV.
This single-center, randomized, open-label, controlled trial will evaluate the efficacy and safety of IVIG therapy in patients with severe or critically ill 2019-nCoV respiratory disease.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult aged >=18years old;
- •Laboratory (RT-PCR) confirmed 2019-nCoV infection in throat swab and/or sputum and/or lower respiratory tract samples;
- •The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;
- •Meet any of the following criteria for severe or critical ill conditions:
- •Respiratory rate >=30/min; or
- •Rest SPO2<=90%; or
- •PaO2/FiO2<=300mmHg; or
- •Respiratory failure and needs mechanical ventilation; or
- •Shock occurs; or
- •Multiple organ failure and needs ICU monitoring;
- •Sign the Informed Consent Form on a voluntary basis.
排除标准
- •Exist of other evidences that can explain pneumonia including but not limited to:
- •influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.;
- •Allergy to Intravenous Immunoglobulin or its preparation components;
- •Patients with selective IgA deficiency
- •Women who are pregnant or breast-feeding;
- •Researchers consider unsuitable.
研究组 & 干预措施
IVIG therapy+ standard care
干预措施: Intravenous Immunoglobulin (Drug)
IVIG therapy+ standard care
干预措施: Standard care (Other)
Standard care
干预措施: Standard care (Other)
结局指标
主要结局
Lower Murray lung injury score
时间窗: 14 days after randomization
Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
Clinical improvement based on the 7-point scale
时间窗: 28 days after randomization
A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
次要结局
- Duration of hospitalization(Measured from Day 0 through Day 28)
- 28-day mortality(Measured from Day 0 through Day 28)
- Proportion of patients with negative RT-PCR results(7 and 14 days after randomization)
- Frequency of Adverse Drug Events(Measured from Day 0 through Day 28)
- Frequency of Serious Adverse Drug Events(Measured from Day 0 through Day 28)
- Proportion of patients with normalized inflammation factors(7 and 14 days after randomization)
- Duration of mechanical ventilation(Measured from Day 0 through Day 28)
- Proportion of patients in each category of the 7-point scale(7,14 and 28 days after randomization)
研究者
LI Taisheng
Director of Infectious Disease, Principal Investigator
Peking Union Medical College Hospital