NCT04595903终止不适用
Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 18
- 主要终点
- Incidence of treatment emergent adverse events
研究概览
简要总结
This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier® in the treatment of SARS-CoV-2 Virus Disease (COVID-19).
详细描述
Up to 40 ICU patients with severe or critical illness due to confirmed COVID-19 infection will be enrolled in up to 20 investigational sites. Patients will receive a four to six-hour treatment with the Hemopurifier® extracorporeal therapy daily for up to four days until discontinued because of clinical improvement or deterioration or upon the decision of the Principal Investigator. The patients will be monitored closely with vital signs and for hemodynamic stability. Patients will be followed for adverse events and device deficiencies. Blood work will be obtained.
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
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
- •Laboratory diagnosis of COVID-19 infection with any of the following disease characteristics:
- •i. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS) ii. Severe disease, defined as:
- •respiratory frequency ≥ 30/min,
- •blood oxygen saturation ≤ 93%,,
- •partial pressure of arterial oxygen to fraction of inspired oxygen ratio of <300 and/or
- •lung infiltrates >50% within 24 to 48 hours; iii. Life-threatening disease, defined as:
- •respiratory failure,
- •septic shock, and/or
- •multiple organ dysfunction or failure.
- •Admission to the ICU or area of the hospital repurposed to function as an ICU for surge capacity management
- •Subject has maintained a MAP of > or = 65 without an increased dose of vasopressors for at least 2 hours and has clinical evidence of adequate volume status per investigative site criteria
- •Informed consent from the patient or legally authorized representative
排除标准
- •Stroke (known or suspected) within the last 3 months.
- •Severe congestive heart failure (NYHA III and IV classes).
- •Biopsy proven cancer not in remission.
- •Acute (an international normalized ratio (INR) of greater than 1.5, and any degree of mental alteration (encephalopathy) in a patient without preexisting cirrhosis and with an illness of less than 26weeks' duration or chronic (Child Pugh C) liver disease.
- •Known pre-existing non-COVID-19 related hypercoagulability or other coagulopathy
- •Terminal illness with a life expectancy of < 28 days or for whom a decision of withdrawal of care is in place or imminently anticipated or patients who have received prior extracorporeal therapy and had persistent, unstable hypotension.
- •Patients with known hypersensitivity to any component of the Hemopurifier.
- •Advance directive indicating to withhold life-sustaining treatment (except Cardiopulmonary Resuscitation).
- •Contraindications to extracorporeal blood purification therapy such as:
- •i. Clinically relevant bleeding disorder, ii. Contraindication to anti-coagulation, iii. Pregnancy, iv. Inability to establish functional vascular access, v. Participation in another competing investigational drug, device or vaccine trial vi. Administration of an angiotensin converting enzyme (ACE) inhibitor in the previous 14 days. vii. Platelet count < 50,000 cells/microliter
结局指标
主要结局
Incidence of treatment emergent adverse events
时间窗: Day 1 (Date of Consent) to Day 28
Safety and tolerability
Incidence of device related adverse events
时间窗: Day 1 (Date of Consent) to Day 14
Safety and tolerability with adverse event graded at 2 or higher
Incidence of serious adverse events
时间窗: Day 1 (Date of Consent) to Day 28
Safety and tolerability
次要结局
- Length if Stay in ICU(Day 1 (Date of Consent) to Day 28)
- In-hospital mortality(Day 1 (Date of Consent) to Day 28)
- Days free of ventilatory dependency(Day 1 (Date of Consent) to Day 28)
- Vasopressor-free days(Day 1 (Date of Consent) to Day 28)
- Sequential Organ Failure Assessment (SOFA)(Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more))
- Acute Physiology and Chronic Health Evaluation (APACHE)(Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more))
- SARS CoV-2 RNA levels in plasma and nasopharyngeal samples(Before each filter treatment, every 2 hours during filter treatment and immediately after filter discontinued)
- Total lymphocyte count(Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more))
- C-reactive protein (CRP), IL-1, IL-6, and TNF alpha Tests(Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more))
- D-dimer(Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more))
- Troponin-T(Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more))
- Evaluation of SARS-CoV-2 RNA levels post-treatment Hemopurifier cartridges(Until study completion, 1 week or for the duration of ICU admission)
- Evaluation of viral particle load post-treatment Hemopurifier cartridges(Until study completion, 1 week or for the duration of ICU admission)
研究者
研究点 (18)
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