NCT04537975撤回不适用
A Randomized Clinical Trial of CLR2.0 Hemofiltration Treatment (C2Rx) in Severe or Critically Ill Adults With COVID-19 Infection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Pulmonary Oxygenation Function
研究概览
简要总结
The clinical trial will evaluate the short term and extended impact on on respiration, pulmonary function and cardiovascular function in C2Rx treatment verse Standard of Care (SOC) in critically ill adults with COVID-19 infections .
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
- •A patient, or legal authorized representative (LAR), has provided informed consent and a written informed consent form.
- •Positive COVID-19 test.
- •Must be receiving medical care in an intensive care nursing situation.
- •Respiratory failure due to COVID-19 disease requiring invasive mechanical ventilation. This care may include but is not required to include the use of dexamethasone.
- •Within 18 hours of tracheal intubation to support invasive mechanical ventilation. A goal of this study is that T0 will occur within 24 hours of tracheal intubation to support invasive mechanical ventilation.
- •Age 18 to 80 years.
- •Males and females (females of childbearing potential who are not pregnant confirmed by a negative serum pregnancy test) and not lactating if recently post-partum).
- •Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
排除标准
- •Cardiovascular instability that precludes initiation of hemofiltration.
- •Irreversible brain damage based on available historical and clinical information.
- •Presence of any solid organ transplant at any time.
- •Patients with stem cell transplant in the previous 100 days or who have not engrafted.
- •Acute or chronic use of circulatory support device such as extracorporeal membrane oxygenation (ECMO), left ventricular assist devices (LVADs), right ventricular assist devices (RVADs), biventricular assist devices (BIVADs).
- •Metastatic malignancy which is actively being treated or may be treated with chemotherapy or radiation during the subsequent three-month period after study treatment.
- •Chronic immunosuppression defined as use of any immunosuppressant medications (cyclophosphamide, azathioprine, methotrexate, rituximab, mycophenolate, cyclosporine); prednisone use is excepted.
- •Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
- •Concurrent enrollment in another interventional clinical trial except trials of COVID-19 convalescent plasma, anti-severe acute respiratory syndrome (SARS)-CoV2 monoclonal antibodies, or RemdesivirTM. Patients enrolled in observational studies (without the use of an investigative device or drug), are allowed to participate. Any communication between the Principal Investigator (PI) of this Protocol and the PI of any other clinical study will include the Medical Director of the Sponsor; all such correspondence will be documented.
- •Any reason the Investigator deems exclusionary
结局指标
主要结局
Pulmonary Oxygenation Function
时间窗: Up to 72 hours
Change in patient Arterial Oxygen Partial Pressure (PaO2)/Fractional Inspired Oxygen (FiO2) Ratio
次要结局
- Survival(30 days and 60 days)
- Hospital Costs 1(Out to 60 days)
- Pulmonary Compliance of Respiratory System (CRS)(Up to 96 hours)
- Hospital Costs 3(Out to 60 days)
- Cardiovascular Vasoactive-Inotropic Score (VIS)(Up to 96 hours)
- Hospital Costs 2(Out to 60 days)
- Hospital Costs 4(Out to 60 days)
- Hospital Costs 5(Out to 60 days)
研究者
相似试验
已完成
3 期
The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)Chronic Obstructive Pulmonary Disease, COPDNCT00108823AstraZeneca550
已完成
2 期
BI 1744 CL With Respimat Once Daily Versus Twice Daily in COPDPulmonary Disease, Chronic ObstructiveNCT00846768Boehringer Ingelheim47
已完成
不适用
Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary DiseaseNCT01020344University of Zurich30
终止
不适用
Sensible Medical Innovations Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure PatientsHeart FailureNCT02448342Sensible Medical Innovations Ltd.380
已完成
4 期
The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the DiskusPulmonary Disease, Chronic ObstructiveNCT03240575Boehringer Ingelheim302