Efficacy and Safety of a Recombinant Neutralizing Human Anti-SARS-CoV-2 Monoclonal Antibody JS016 in Chinese Hospitalized Patients With SARS-CoV-2 Infection (COVID-19): a Multicenter, Randomized, Open-label, Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Clinical status at 28 days
研究概览
简要总结
The human monoclonal antibody CB6 showed potent neutralization activity in vitro against SARS-CoV-2. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. We aim to evaluate the efficacy and safety of JS016 in patients hospitalized with COVID-19.
详细描述
As the COVID-19 pandemic is emerging as a global healthcare crisis, scientists worldwide are actively developing prophylactic and therapeutic interventions. Neutralizing antibody therapies are being developed for the treatment of COVID-19. The human monoclonal antibody CB6 showed potent neutralization activity in vitro against SARS-CoV-2. The LALA mutation was introduced to the Fc portion of CB6 (CB6-LALA) to lower the risk of Fc-mediated acute lung injury in animals. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. We aim to evaluate the efficacy and safety of JS016 in patients hospitalized with COVID-19. The data from this study will inform decisions of the clinical use of JS016.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) infection
- •Within 7 days from the onset of clinical symptoms or 4 days from the onset of severe symptoms
- •Consistent with the National Health Committee New Coronavirus pneumonia diagnosis and treatment plan (Eighth Edition), general or heavy diagnostic criteria.
排除标准
- •Sever Covid-19 Infection patients
- •SARS-Cov-2 specific antibodies (including IgM and IgG) were positive before included
- •Cardiac function grade III or IV, or left ventricular ejection fraction < 30%
- •History of known or suspected active pulmonary tuberculosis or extra-pulmonary tuberculosis
- •Chronic renal failure needs maintenance dialysis
- •History of solid malignant/tumor or hematological malignancy
- •Pregnancy or lactation
研究组 & 干预措施
JS016 treatment group
Standard therapy + JS016 injection Standard therapy including vital sign monitoring, supplementary oxygen and respiratory support in accordance with the patient's oxygen saturation and respiratory condition.
干预措施: JS016 (Drug)
结局指标
主要结局
Clinical status at 28 days
时间窗: At 28 days from inclusion
Clinical status at 28 days assessed using a six level ordinal scale，in this scale, 1 is the minimum score and presenting a better outcome as discharge, 2 means still in-hospital but no need of oxygen therapy, 3 presents in-hospital and needing of oxygen therapy, 4 presents in-hospital needing high flow nasal oxygen therapy or non-invasive mechanical ventilation, 5 presents in-hospital needing invasive mechanical ventilation or ECMO, 6 presents death and is the worse outcome as well.
次要结局
- Average length of hospital stay(At 28 days from inclusion)
- Negative conversion rate of SARS-CoV-2 nucleic acid in on days 14 after randomization(At 14 days from inclusion)
- All cause mortality ascertained from data analysed to day 28(At 28 days from inclusion)
- Ventilator-free days within 28 days(At 28 days from inclusion)