Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the Treatment of Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 8
- 主要终点
- Change in Organ failure
研究概览
简要总结
Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19
详细描述
This is a prospective, open-label, randomized, controlled clinical investigation designed to evaluate the safety and effectiveness of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the treatment of patients with confirmed SARS-CoV-2 infection.
The clinical investigation will be conducted at 3 centers in Germany and at 2 centers in Spain. Subjects will be randomized to the treatment group (Seraph 100 + standard of care) versus control group (standard of care only).
Subjects will be followed for 28 days. For viral quantification, study-related serum samples are done immediately before the initial treatment with Seraph 100 starts in the treatment group or immediately after randomization into the control group. Additionally, serum sampling at timepoint 12 hours is applicable for both treatment and control group.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with confirmed SARS-CoV-2 infection
- •Be ≥ 18 years old and ≤90 years old
- •Acute respiratory distress syndrome assessed by a modified Sequential Organ Failure Assessment score of at least 2 points
- •At least one additional organ dysfunction assessed by a modified Sequential Organ Failure Assessment score of at least 1 point
- •Written or electronic consent of the subjects who are legally competent and have the capacity to give consent
排除标准
- •Subject is currently participating in another clinical investigation
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- •Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
- •Have Child-Pugh Class C cirrhosis
- •Have platelet count <30.000/uL
- •Contraindications for heparin sodium for injection
- •Subjects demonstrating any contraindication for this treatment as described in the IFU
- •Subjects with known allergy of polyethylene and copolyester
- •Subjects with hospital-acquired SARS-CoV-2 infections
- •Subject is held in an institution by court or official order
- •Subject is dependent on the sponsor or investigator so that consent can no longer be considered voluntary
研究组 & 干预措施
Treatment
Extracorporeal therapy with Seraph 100 blood filter
干预措施: Seraph 100 (Device)
Control
patients receive antibiotics only as standard of care
结局指标
主要结局
Change in Organ failure
时间窗: 48 hours after initial treatment
Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 48 hours
次要结局
- Ventilator-free days (VFDs)(Daily during ICU stay (up to 28 days))
- Prognosis Factors(From baseline up to 48 hours)
- Recurrence of sepsis(7 days)
- Persistence of sepsis(7 days)
- Organ dysfunction-free days(Daily during ICU stay (up to 28 days))
- Change in Organ Failure(Daily during ICU stay from the start of the initial treatment until day 4)
- All-cause mortality(28 days)
- Length of stay (LOS) at ICU and hospital ward(During ICU and hospital ward stay (up to 28 days))
- Intensive Care Unit (ICU) complications(Daily during ICU stay (up to 28 days))