Randomized Controlled Phase 2b Clinical Study in Parallel Groups for the Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma Plus Standard Treatment vs. Standard Treatment Alone of Subjects With Severe COVID-19
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in SOFA score from Baseline Visit
研究概览
简要总结
This phase 2b clinical study will enroll adult subjects of both sexes with ARDS due to COVID-19 necessitating invasive mechanical ventilation.
详细描述
The primary objective of the study is the assessment of impact of immune therapy with COVID-19 convalescent plasma on severity of COVID-19.
The secondary objectives is the Impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection; short-term all-cause mortality; time course of ARDS due to severe COVID-19 and assessment of safety and tolerability of immune therapy with COVID-19 convalescent plasma.
As a primary endpoint/variable we will assess change in SOFA score from Baseline Visit to Day 8.
The study design will be prospective, open-label, randomized, controlled and parallel-grouped.
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
- •Male or female subject aged ≥18 years.
- •Estimated BMI ≥19kg/m² to ≤40kg/m².
- •Florid1 SARS-CoV-2 infection confirmed by RT-PCR in tracheo-bronchial secretion sample or pharyngeal swab sample.
- •ARDS with Horovitz index <300mmHg.
- •Necessity of invasive mechanical ventilation.
- •Written informed consent obtained from the subject's legal representative or under such arrangement as is legally acceptable in Germany (
- •Subject's assent if obtainable
排除标准
- •Previous exposure to COVID-19 convalescent plasma.
- •Adverse reaction to plasma proteins in medical history.
- •Interval >72h since endotracheal intubation.
- •Current or imminent necessity of ECMO treatment.
- •Pre-existing COPD GOLD stage
- •Chronic congestive heart failure NYHA ≥
- •Pre-existing left ventricular ejection fraction <30%.
结局指标
主要结局
Change in SOFA score from Baseline Visit
时间窗: [Day 1, Visit 2] to Day 8 [Visit 9]
Change in Sequential organ failure assessment (SOFA) score predicts Predicts ICU mortality based on lab results and clinical data. SOFA includes PaO2, the Glasgow Coma Scale, Mean arterial pressure OR Administration of sedatives, Bilirubin(mg/dl), Creatinine (mg/dl) and platelets. All values are rated with a value of 1 to 4 (worst condition) and are added up gradually to a final score. The lower the SOFA score, the better is the prognosis (Maximum value 24)
次要结局
- Assessment of impact of immune therapy with COVID-19 convalescent plasma on PEEP in patients with ARDS due to severe COVID-19(Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15])
- Assessment of impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection(Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15])
- Assessment of impact of immune therapy with COVID-19 convalescent plasma on short-term all-cause mortality(Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15])
- Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen supply in patients with ARDS due to severe COVID-19(Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15])
- Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen demand in patients with ARDS due to severe COVID-19(Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15])
- Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of Oxygen supply in patients with ARDS due to severe COVID-19(Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15])
- Assessment of impact of immune therapy with COVID-19 convalescent plasma on FiO2 in patients with ARDS due to severe COVID-19(Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15])
- Assessment of impact of immune therapy with COVID-19 convalescent plasma on driving pressure in patients with ARDS due to severe COVID-19(Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15])
- Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of invasive mechanical Ventilation in patients with ARDS due to severe COVID-19(Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15])