Evaluation of the Potential Benefit of Renin-angiotensin System Inhibitors (RASi, ACEi/ARB) in High-risk Patients With COVID-19. The COVID-RASi Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 31
- 主要终点
- Hospitalizations
研究概览
简要总结
The COVID-RASi study is an international randomized clinical trial that will evaluate the potential benefit of angiotensin modulators on clinical outcomes, in COVID-19 patients. The purpose of this study is to determine if renin-angiotensin system inhibitors (RASi), with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB), has a beneficial effect in patients with COVID-19 infections, by reducing ICU admission, ventilator requirement or death. We would also like to determine if there are differences between ACEi and ARB therapeutic treatments. With the increasing potential of long COVID symptoms, at the 1 year follow up, a primary endpoint will be the quality of life of study participants, as assessed by ongoing symptoms and/or the standardized questionnaires.
详细描述
The goal is to determine if RASi with ACEi or ARB, has a beneficial effect in patients with COVID-19 infections, by reducing hospitalizations, ICU admission, ventilator requirement or death.
This is a multi-centre study, conducted in major centres treating COVID-19 patients in-hospital and in various outpatient settings.
Patients admitted to hospital or outpatients that test positive for COVID-19 and meet the inclusion/exclusion criteria will be eligible to participate in this study. All study participants will not be on RASi (ACEi/ARB) treatment at the time of consent. Participants will be randomized to initiation of ACEi vs ARB treatment vs no RASi treatment as part of care for COVID-19 in a 1:1:1 ratio.
The patient will be followed by their physician according to usual clinical care. Sites will complete research-related follow-ups at 24 hours, 7 and 28 days to asssess patient's clinical status, side effects and the achievement of clinical endpoints by telephone interviews. Phone call follow ups will also be conducted at 6 months and 12 months after enrollment in the study.
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
- •Patient with COVID-19 diagnosis with laboratory confirmation within the last 30 days AND
- •Age 40 years old or greater if outpatient OR age 18 years old or greater if inpatient (admitted to the hospital) at time of recruitment
排除标准
- •Contraindication to ARB or ACEi, including severe aortic stenosis and angioedema
- •Patients who are currently on active treatment with ARB/ACEi
- •Known bilateral renal artery stenosis
- •Systolic BP ≤90 mmHg
- •eGFR<30 ml/min, if not receiving dialysis treatment
- •K>5.5 mmol/L on screening laboratory testing
- •Recent history of dizziness, vertigo, related to hypotension or orthostatic hypotension, that can lead to contraindication to ACEI/ARBs
- •Acute respiratory distress syndrome requiring invasive ventilation
研究组 & 干预措施
ACEi treatment
The physician will initiate any ACE inhibitor and dose at their discretion.
干预措施: Angiotensin converting enzyme inhibitor (Drug)
ARB treatment
The physician will initiate any ARB and dose at their discretion.
干预措施: Angiotensin II Receptor Blockers (Drug)
No Treatment (Standard of Care)
Participants will be treated as per standardized care pathway according to province/state and institutional guidelines. Physicians will be reminded not to start ACEi or ARB throughout admission or to outpatients until active study participation is complete at 28 days post symptoms.
结局指标
主要结局
Hospitalizations
时间窗: 28 days
Within first 28 days post randomization
Death
时间窗: 28 days
Within first 28 days post randomization
ICU admission
时间窗: 28 days
Within first 28 days post randomization
Mechanical ventilation
时间窗: 28 days
Within first 28 days post randomization
Major Adverse Cardiac Events (MACE)
时间窗: 28 days
Within first 28 days post randomization
Quality of life of study participants
时间窗: 1 year
Assessed by ongoing symptoms and standardized questionnaires, scale to assess overall health 1-100, 100 is the best, higher score means better outcome
次要结局
- Days alive and out of hospital(180 days)
- Cardiovascular mortality(1 year)
- All cause hospitalization(1 year)
- Percent of patients require intensive care(1 year)
- Percent of patients requiring ventilation(1 year)
- Percent of patients requiring dialysis(1 year)
- Days alive and out of hospital(30 days)