Stopping ACE-inhibitors in COVID-19: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 31
- 主要终点
- Composite of the Maximum Sequential Organ Failure Assessment (SOFA) Score and Death Within 30 Days
研究概览
简要总结
ACEI-COVID-19 is a multicenter, randomized trial testing the hypothesis that stopping/replacing chronic treatment with ACE-inhibitors (ACEI) or angiotensin receptor blockers (ARB) improves outcomes in symptomatic SARS-CoV2-infected patients
详细描述
The COVID-19 pandemic currently poses unprecedented challenges to the health systems of all countries. Experimental studies show that the SARS-CoV2 virus enters human cells via the angiotensin converting enzyme II receptor 2 (ACE2). ACE inhibitors (ACEI) and angiotensin receptor blockers (ARB) can lead to an increase in the expression of ACE2. Therefore, there is concern that in patients treated with ACEI or ARB, the absorption of the virus is facilitated, thereby accelerating its spread in the body.
ACEI-COVID tests the hypothesis that stopping chronic ACEI / ARB therapy in SARS-CoV2-infected patients improves outcomes.
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
- Single (Outcomes Assessor)
盲法说明
unmasked
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
- •Female and male patients competent to make a decision
- •Proven and symptomatic SARS-CoV2 infection ≤ 5 days
- •Patient age ≥ 18 years
- •Provided written informed consent
- •Chronic (≥ 1 month) ACEI/ARB therapy for treatment of arterial hypertension, diabetes mellitus, heart failure or coronary artery disease
- •Stable hemodynamic conditions allowing to stop or continue treatment with ACEI/ARB (systolic blood pressure ≤180mmHg)
排除标准
- •Women capable of bearing children as well as pregnant and breastfeeding women
- •Participant in another interventional trail
- •At screening visit, no oral medication intake possible
- •Advanced heart failure NYHA Stage III-IV
- •Left ventricular ejection fraction <30% or NTproBNP ≥600pg/mL in case of clinical signs of heart failure
- •Acute coronary syndrome ≤ 3 months
- •Severe arterial hypertension (concomitant use of more than 4 different antihypertensive drug classes)
- •Acute respiratory distress syndrome with need for mechanical ventilation
- •Patients who at not capable of home blood pressure monitoring
- •Patients who cannot be switched to an alternative medication
研究组 & 干预措施
Stopping/replacing ACEI/ARB
Chronic treatment with ACEI or ARB will be stopped or replaced.
干预措施: ACE inhibitor, angiotensin receptor blocker (Drug)
结局指标
主要结局
Composite of the Maximum Sequential Organ Failure Assessment (SOFA) Score and Death Within 30 Days
时间窗: 30 days
The score is calculated from six different components, each of which reflects the status of an organ system, including respiratory function, cardiovascular integrity, liver function, coagulation, renal function and neurological status. The score can range from 0 (best) to 24 (worst). In case of death, the patient was by definition assigned the maximum value of 24. Outpatients were assigned a value of 0 or 24 (in the case of death).
Composite of Admission to an Intensive Care Unit (ICU), the Use of Mechanical Ventilation, or All-cause Death
时间窗: 30 days
Composite of admission to ICU, mechanical ventilation, and death
次要结局
- Rates of Non-invasive Ventilation(30 days)
- Number of Patients With Systolic/Diastolic Blood Pressure > 180/120 mmHg(30 days)
- Rates of Mechanical Ventilation(30 days)
- Rates of Renal Replacement Therapies(30 days)
- Mean of Sequential Organ Failure Assessment (SOFA) Score(30 days)
- Hospitalisation Due to Cardiac Decompensation(30 days)