A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIOR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Incidence of changes in specific clinical events in patients with covid-19.
研究概览
简要总结
The purpose of this study is to asses the efficacy of the Gammacore device reducing the need for mechanical ventilation in patients diagnosed of Covid-19
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has been tested positive or suspected/presumed positive for CoViD-19
- •Patients with cough, shortness of breath or respiratory compromise (RR>24/min, increased work of breathing.)
- •O2 Saturation less than or equal to 96% on room air or sensation
- •Agrees to use the gammaCore®-Sapphire device as intended and to follow all of the requirements of the study including recording required study data
- •Patient is able to provide signed and witnessed Informed Consent
排除标准
- •On home/therapy oxygen (i.e. for COPD patients) at baseline prior to development of CoViD-19
- •Is already enrolled in a clinical trial using immunotherapeutic regimen for CoViD-19
- •Already gammaCore for other medical conditions
- •A history of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma
- •Known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (eg, bruits or history of transient ischemic attack or cerebrovascular accident), congestive heart failure, known severe coronary artery disease, or recent myocardial infarction
- •Uncontrolled high blood pressure (>140/90)
- •Current implantation of an electrical and/or neurostimulator device, including but not limited to a cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
- •Current implantation of metal cervical spine hardware or a metallic implant near the gammaCore stimulation site
- •Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g. homeless, developmentally disabled and prisoner)
- •Compromised access to peripheral veinous for blood)
- •Pregnant women
结局指标
主要结局
Incidence of changes in specific clinical events in patients with covid-19.
时间窗: From randomization to hospital discharge or ICU admission, whatever occurs first, assessed up to two months
The clinical events include, but are not limited, to: * Proportion of subjects requiring mechanical ventilation * Days to onset of mechanical ventilation * Oxygen support requirements * O2 saturation * Pain levels * PaO2/FiO2 * Coagulation * Laboratory measurements related to circulating cytokines and inflammation. * Live discharge from the hospital * Patient length of stay * Mortality * Need for intensive care * Shortness of breath * Device related serious adverse events * Adverse events
次要结局
未报告次要终点
研究者
Carlos Tornero
Doctor
Hospital Clínico Universitario de Valencia