Switch or Maintenance of Renin-Angiotensin System Inhibitors in Patients With Covid-19: A Randomized Proof of Concept Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Need for ICU or mortality
研究概览
简要总结
The SWITCH-COVID trial will randomize patients with COVID-19 that are currently using renin-angiotensin system inhibitors for treating hypertension to maintain the therapy during in-hospital stay or switch the therapy to other antihypertensive classes.
详细描述
Patients eligible for the study, after signing informed consent will be randomized 1:1 for maintenance of renin-angiotensin system inhibitors or switching the antihypertensive therapy for other classes according to a pre-specified protocol.
Patients are going to be followed during hospital stay for evaluation of clinical endpoints. Also blood and urine samples will be acquired for evaluation of renin-angiotensin system activation.
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
- •Hypertension in use of renin-angiotensin system inhibitors
- •Confirmed COVID-19 infection by rt-PCR, serology tests or typical clinical presentation and chest CT.
- •Symptoms onset < 96h
- •Need for hospitalization
排除标准
- •Heart failure
- •Previous cerebrovascular disease
- •Previous myocardial infarction
- •Blood pressure > 180 x 100 mmHg
- •Need for 3 or more anti-hypertensive classes
- •Use os spironolactone
- •Severe pulmonary disease
- •Contraindication for using other anti-hypertensive classes (calcium channel blockers, hydralazine, diuretics or nitrates)
研究组 & 干预措施
Switch therapy
Renin-angiotensin system inhibitors will be changed for other anti-hypertensive classes.
干预措施: Renin-angiotensin system inhibitors (Drug)
结局指标
主要结局
Need for ICU or mortality
时间窗: 30 days
Combined of need for ICU or mortality
次要结局
- ACE-2 activity and disease severity(30 days)
- Blood control and acute renal failure(30 days)
- High sensitivity troponin levels and covid-19 severity(30 days)
- ACE-2 activity with different Renin-angiotensin system inhibitors(30 days)
研究者
Bruno Caramelli
MD. PHD.
University of Sao Paulo