Single Center, Single Arm, Open Clinical Study to Access Safety and Initial Efficacy of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- 2019 nCoV nucleic acid detection
研究概览
简要总结
To evaluate the safety and efficacy of humanized Meplazumab for Injection in patients infected by 2019-nCoA.
详细描述
According to the results of nonclinical study of humanized Meplazumab for Injection, a single dose will be used for the treatment. The treatment plan is first dose on the first day (0d) and second dose on the second day (1D) of the treatment period by intravenous(IV) infusion, each dose 10mg; The third dose will be given within 3-5 days after the second dose according to the patient's 2019-nCoV nucleic acid load, clinical manifestations and the overall evaluation of doctors, dose is 10mg. 30 mg of methylprednisolone will be given intravenously 30 minutes before each administration. Each subject will be evaluated the therapeutic effect within 28 days after the first administration, and to determine the preliminary therapeutic effect, safety and tolerability of humanized Meplazumab for Injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 75 years (inclusive)
- •In line with the new coronavirus infection pneumonia diagnosis and treatment plan (trial version 4) issued by the Health Commission, patients with new coronavirus (2019 ncov) pneumonia were clinically diagnosed;
- •The subjects must be able to understand the study and willing to participate in the study, and sign the informed consent (if the subjects with no behavioral ability think it is in their own interests to participate in the test, they should sign the informed consent by their legal guardian, or notify the consent by phone (recording) and explain it in the original medical record and other relevant documents).
排除标准
- •Known or expected to have allergic reactions or a history of allergy to any of the ingredients treated in this trial;
- •In the judgment of the investigator, there are other reasons that the patient is not suitable to participate in this study.
研究组 & 干预措施
Meplazumab
10mg Meplazumab by intravenous infusion, every day for 2 days
干预措施: Meplazumab for Injection (Drug)
结局指标
主要结局
2019 nCoV nucleic acid detection
时间窗: 14 days
Virological clearance rate using Real-Time PCR in upper and/or lower respiratory tract samples at day 3, day 7 and day 14 respectively.
次要结局
- Changes of inflammatory immune status(14 days)
- Chest CT / chest film changes(28 days)
- Recovery of resting respiratory rate(14 days)
- Recovery of SPO2(14 days)
- Time to reach the isolation release standard(28 days)
- Recovery of body temperature(14 days)
- PaO2 / FiO2(14 days)