Effects of RAS Inhibitors (ARB, ACEi, DRI) in People With Hypertension 1-2 Stages on the Course of COVID-19 (BIRCOV Trial: ARB, ACEI, DRi Effects on COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Level of BP in mm Hg
研究概览
简要总结
It is supposed to monitor hypertensive patients who are infected or have clinical manifestations of COVID-19 for 1 month after the onset of the disease. Three groups will be considered: 1. receiving ACE inhibitors 2. receiving ARBs 3. receiving DIR.
详细描述
POEM (Patient-Oriented Evidence that Matters) intervention is performed as an open prospective randomized two medical centres trial in subjects suffering from COVID-19 who have been receiving iRAS, either ACEi, ARB or DRi as basic antihypertensive therapy.
COVID-19 is confirmed by a PCR test, the disease follow-up is divided into 2 periods: up to 12 weeks and up to 24 weeks.
Primary Outcome Measure: BP was known one week before COVID-19 and is tested during the disease onset on weeks 2, 4, 12, 24. Secondary Outcome Measures are clinical features. Subanalysis in patients with CKD is additionally performed for those who have CKD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertensive person, stage 1-2
排除标准
- •Hypertensive subjects, stage 3, HF (NYHA) 3-4
研究组 & 干预措施
ARB group
Hypertensive patients with COVID-19 who received ARBs
干预措施: Angiotensin Receptor Blockers (Drug)
ACEi group
Hypertensive patients with COVID-19 who received ACEis
干预措施: Angiotensin converting enzyme inhibitor (Drug)
DRi group
Hypertensive patients with COVID-19 who received direct renin inhibitor (DRis)
干预措施: Direct renin inhibitor (Drug)
结局指标
主要结局
Level of BP in mm Hg
时间窗: estimated at 2, 4, 12, 24 weeks after the start of COVID-19; data for 24 weeks are reported
BP in patients one week before COVID-19 infection and 2, 4, 12, 24 weeks follow-up after COVID-19 onset
次要结局
- Number of Patients With Cough in COVID-19 Course(on 2,4 and 12 week from COVID-19 onset)
- Number of Patients With Throat Pain in COVID-19 Course(estimated at 2, 4, 12 weeks after the COVID-19 onset)
- Number of Patients With Fever Above 37.2 on COVID-19 Course(estimated at 2, 4, 12 weeks after the COVID-19 onset)
- Number of Patients With Diarrhea Inf COVID-19 Course(estimated at 2, 4, 12 weeks after the COVID-19 onset)
- Number of Patients Who Need to Apply to Hospital in COVID-19 Course(estimated at 2, 4, 12 weeks after the COVID-19 onset)