Prospective, Open-label Study of Seraph 100 in Patients With Prolonged COVID (PC)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of Technical Procedure Success
研究概览
简要总结
This study will use a prospective, open, single-arm design, in which a group of 100 patients with a diagnosis of prolonged COVID, previously selected according to inclusion and exclusion criteria, and who have undergone informed consent process and have signed the informed consent form, undergo two hemoperfusion procedures with the Seraph 100 filter, on consecutive days. They are then evaluated at day 3 and 4 weeks, to complete the safety and effectiveness assessment.
详细描述
This will be a prospective, open-label, single-arm, pilot study, in which a group of 100 PC patients will undergo two hemoperfusion procedures, to verify the safety and preliminary efficacy of the Seraph 100 device. Eligible patients will be invited to participate and once they sign the Informed Consent (IC) they will undergo two hemoperfusion procedures, on consecutive days, of -4 hours duration each time, using a multicomponent apheresis machine with the Seraph 100 filter. Patients will be followed for a total of 30 days, to monitor the presence of AEs (safety) and possible changes in clinical outcomes (preliminary efficacy).
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
盲法说明
Unblinded
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
- •Subjects will be considered eligible for participation in the study if they meet all the following inclusion criteria:
- •Adult patients age of 18-85 (had 18th birthday but did not have 85th birthday).
- •History of COVID 19 infection established by positive polymerase chain reaction (PCR) test or by compatible clinical testing (e.g. rapid antigen, serum testing, or other relevant clinical documentation).
- •Persistent symptoms for 12 or more weeks after acute COVID 19 infection including fatigue and one or more of the following: myalgia or generalized aches and pains; joint pain; dizziness or unsteadiness; cognitive dysfunction (mental fog).
- •Patient (legally designated representative) has completed the Informed Consent process prior to enrollment into this study.
- •Patient (legally designated representative) is willing to comply with the study protocol -
排除标准
- •Subjects meeting any of the following criteria will not be recruited for the study:
- •History of heparin allergy.
- •History of heparin-induced thrombocytopenia.
- •Pregnancy or breastfeeding.
- •Life expectancy is less than 30 days.
- •The patient is currently enrolled in another drug or device trial. Patients who cannot tolerate placement of double-lumen catheter.
- •Unable to obtain informed consent from either patient or legally authorized representative (LAR)Any subject who, in the investigator's judgment, is considered unsuitable for participation in this trial.
- •After verification of eligibility and signature of consent:
- •1. The patient must be able to perform a hemoperfusion procedure with an apheresis machine.
研究组 & 干预措施
Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single use
The Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single use, disposable column packed with ultra-high molecular weight polyethylene (UHMWPE) beads. These beads have been modified to contain endpoint-attached heparin on the surface, thus forming a new chemical entity, the polymer now containing material of animal origin (porcine mucosa). The devices are sterilized using a standard ethylene oxide (EtO) cycle, following ISO 11135:2014.
干预措施: Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) (Device)
结局指标
主要结局
Assessment of Technical Procedure Success
时间窗: Procedure Stop Time
Procedural Success is defined as: 1. Device use as originally intended, and 2. No device procedure related serious adverse events (SAEs)
Assessment of Device Success
时间窗: 3, 7 and 28 days
Seraph 100 Device Success
次要结局
未报告次要终点