An Exploratory Clinical Study on the Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured 2019-nCoV Pneumonia Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Time to Clinical Improvement (TTCI)
研究概览
简要总结
The new coronavirus pneumonia is an acute infectious pneumonia. The pathogen is a previously unknown new coronavirus, namely 2019 new coronavirus (2019 novel coronavirus, 2019 nCoV). However, there is no specific anti-viral drug. It has been found that the specific antibodies against virus antigen are produced after these patients were cured, which could block the infection of 2019 nCoV on the host cells. At present, immunoadsorption is the most direct, rapid and effective method to separate immunoglobulin from the cured patients. Therefore, the study aims to prepare the immunoglobulin from 2019-ncov pneumonia cured patients, evaluate the efficacy and safety of the immunoglobulin in 2019-ncov pneumonia cured patients on the treatment of acute severe 2019-ncov pneumonia, and provide a new strategy for the treatment of 2019-ncov pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Volunteers who have understood and signed the informed consent;
- •Age ≥18 years, gender unlimited;
- •Patients diagnosed with acute severe 2019-nCoV pneumonia:
- •Laboratory (RT-PCR) confirmed infection with 2019-nCoV.
- •Lung involvement confirmed with pulmonary CT scan.
- •At least one of the following conditions should be met: respiratory distress, RR ≥ 30 times/min; oxygen saturation ≤ 93% in resting state; PaO2/FiO2 ≤ 300mmHg; respiratory failure and mechanical ventilation are required; shock occurs; ICU monitoring and treatment is required in combination with other organ failure.
排除标准
- •Viral pneumonia with other viruses besides 2019-nCoV.
- •Patients are not suitable for immunoglobulin therapy.
- •Participation in other studies.
- •Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial.
研究组 & 干预措施
Treatment group
Immunoglobulin of cured patients
干预措施: Immunoglobulin of cured patients (Drug)
Control group
γ-Globulin
干预措施: γ-Globulin (Drug)
结局指标
主要结局
Time to Clinical Improvement (TTCI)
时间窗: up to 28 days
TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.
次要结局
- Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days](up to 28 days)
- The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days](up to 28 days)
- Clinical status assessed by the ordinal scale(up to 28 days)
- The differences in oxygen intake methods(up to 28 days)
- Duration (days) of supplemental oxygenation(up to 28 days)
- Duration (days) of mechanical ventilation(up to 28 days)
- The mean PaO2/FiO2(up to 28 days)
- Dynamic changes of 2019-nCoV antibody titer in blood(up to 28 days)
- Length of hospital stay (days)(up to 28 days)
- All cause mortality(up to 28 days)
研究者
Xiang Cheng
Head of department of cardiology, Wuhan Union Hospital, China
Wuhan Union Hospital, China