An Open-label, Randomized, Parallel-arm Study Investigating the Efficacy and Safety of Intravenous Administration of Pamrevlumab Versus Standard of Care in Patients With COVID-19 (FibroCov-01 / FGCL-3019-IST-014)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Proportion of patients not on ventilatory support
研究概览
简要总结
This is a randomized, open-label, parallel-arm study to investigate the efficacy and safety of pamrevlumab in patients with documented SARS-CoV-2 infection. The study consists of screening, a treatment period, and a follow-up period.
The study will enroll patients who have been hospitalized and who are not currently on invasive mechanical ventilation. The treatment period is open ended, and patients will be randomized to treatment with pamrevlumab or standard of care in a 1:1 ratio according to a pre-generated randomization list. Pamrevlumab dosing, 30 mg/kg IV, will be administered at day 1, day 7 and day 14. Based on Investigator's decision, treatment may be continued every 3 weeks after day 14, up to 11 weeks. A follow-up by visit or phone call will be performed 8 and 12 weeks after the end of the last dose of treatment. The treatment period for an individual patient will not exceed 11 weeks.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented COVID-19 infection
- •Age >=18 to <=80 years
- •Interstitial pneumonia (findings of consolidation or ground glass opacities as assessed by chest HRCT)
- •Respiratory distress, defined as PaO2/FiO2 ratio of >=100 <=300 mmHg, requiring supplemental oxygen and hospitalization
排除标准
- •Invasive mechanical ventilation at screening
- •Pregnancy
- •Incapacity to express a valid informed consent
- •Known hypersensitivity to monoclonal antibodies used as experimental drugs for any clinical indication
研究组 & 干预措施
Pamrevlumab
干预措施: Pamrevlumab (Drug)
结局指标
主要结局
Proportion of patients not on ventilatory support
时间窗: 15 days
次要结局
- Proportion of patients alive(within 28 days)
- PaO2/FiO2 ratio as categorical variable(Day14)
- For patients already on mechanical ventilator at time of randomization, the number of days on ventilator after randomization.(up to 12 weeks)
- PaO2/FiO2 ratio as continuous variable(Day14)
- Change in oxygen supplementation requirements (liters per minute)(Day14)
- Quantitative and qualitative assessment of pulmonary lesions by chest HRCT scans at baseline and at day 14 and week 12(Day 14 and week 12)
- Time to all-cause mortality(up to 28 days)
- Resting SpO2 adjusted by FiO2(Day14)
- Proportion of patients discharged from ICU and alive(within 28 days)
- Time to hospital discharge(up to 12 weeks)
- For patients not on mechanical ventilator at time of randomization, the number of days not requiring invasive mechanical ventilation(up to 12 weeks)