A Pilot, Open-Label Study of NovoTTF-100L (TTFields, 150Hz) in Hospitalized Patients With COVID-19 and Continued Treatment After Hospitalization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Frequency and severity of adverse events
研究概览
简要总结
The study is a prospective, pilot study aimed to test the safety of Tumor Treating Fields (TTFields) concomitant with best standard of care, for the treatment of hospitalized COVID-19 patients and continued treatment after hospitalization. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields) to the region of the organ to be treated, by means of surface, insulated electrode arrays.
详细描述
PAST PRE-CLINICAL AND CLINICAL EXPERIENCE:
Tumor Treating Fields (TTFields) are a non-invasive, regional antimitotic treatment modality with minimal toxicity which have been approved for the treatment of recurrent and newly diagnosed glioblastoma (GBM) by the Food and Drug Administration (FDA) in the United States and have obtained a CE mark in Europe for the same indications. TTFields concomitant with chemotherapy were also approved for malignant pleural mesothelioma under FDA's humanitarian device exemption.
Cell culture study demonstrated that TTFields can significantly reduce corona virus infection and replication in human lung cells.
DESCRIPTION OF THE STUDY:
All patients included in this study are patients who are hospitalized due to COVID-19 disease. In addition, all patients must meet all eligibility criteria.
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
- •Age ≥ 18 years.
- •Hospitalized with diagnosis of COVID-19 infection per reverse transcription polymerase chain reaction (RT-PCR) within 72 hours prior to treatment start.
- •SpO2 ≤ 93% at sea level.
- •Lung involvement confirmed with chest imaging.
- •Able and willing to comply with all study procedures.
- •Female participants of childbearing age must use highly effective contraception.
- •All patients must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
排除标准
- •Receipt of any experimental treatment for COVID-19 prior to or during the study.
- •Assisted ventilation.
- •Critical illness: respiratory failure defined as oxygen saturation by pulse oximetry/inspired oxygen fraction (SpO2/FiO2) ratio < 150, septic shock, and/or multiple organ dysfunction.
- •Significant co-morbidities at baseline as determined by the investigator:
- •Clinically significant hematological, hepatic and renal dysfunction, defined as: Neutrophil count < 1.5 x 10^9/L and platelet count < 100 x 10^9/L; bilirubin > 1.5 x upper limit of normal (ULN); aspartate aminotransferase (AST) and/or alanine transaminase (ALT) > 2.5 x ULN; and serum creatinine > 2.5 mg/dL.
- •History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class IV (unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases).
- •History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the study.
- •History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent.
- •Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso.
- •Pregnancy or breast-feeding.
- •Known allergies to medical adhesives or hydrogel.
- •Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's cooperation or other unspecified reasons that, in the opinion of the Investigator or sponsor, make the subject's enrollment incompatible with study objectives.
结局指标
主要结局
Frequency and severity of adverse events
时间窗: 2 months
次要结局
- Time to recovery(Day 1 through Day 29)
- All-cause mortality(Day 1 through Day 29)
- Patient inflammatory status(Day 3, 8, and 11)
- Duration of hospitalization(Day 1 through Day 29)
- Incidence of intensive care unit admission(Day 1 through Day 29)
- Incidence of non-invasive ventilation or high-flow oxygen use(Day 1 through Day 29)
- Incidence of invasive ventilation(Day 1 through Day 29)
- Incidence of extracorporeal membrane oxygenation(Day 1 through Day 29)
- Clinical status at day 8, 15, 22, 29(Day 8, 15, 22, and 29)