ACE Inhibitors or ARBs Discontinuation for Clinical Outcome Risk Reduction in Patients Hospitalized for the Endemic Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection: the Randomized ACORES-2 Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Time to clinical improvement from day 0 to day 28 (improvement of two points on a seven-category ordinal scale, or live discharge from the hospital, whichever comes first)
研究概览
简要总结
Since December 2019, a novel coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as COVID-19.
Individuals with a history of cardiovascular disease develop a more severe illness and have higher rates of death.
Because of the potential interaction between RAS blockers and SARS-CoV-2 mechanism of infection, there are ongoing scientific discussions on whether they should be stopped or continued in patients with COVID-19.
It is crucial to determine whether RAS blockers should be discontinued or not in patients with 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
- •Age ≥ 18 years old.
- •Chronically treated with RAS blockers (ACE inhibitors or ARBs on the last prescription prior to admission with a treatment duration ≥ 1 month).
- •Diagnosis of COVID-19 confirmed by the presence of SARS-CoV-2 on any biological sample with any detection method.
- •Patients hospitalized in a non-intensive care unit.
- •Pregnancy test at inclusion visit for women of childbearing potential.
- •Women of childbearing potential must agree to use adequate contraception according to recommendations related to contraception and pregnancy testing in clinical trials, by Clinical Trial Facilitation Group (CTFG).
排除标准
- •Shock requiring vasoactive agents.
- •Acute respiratory distress syndrome requiring invasive mechanical ventilation.
- •Circulatory assistance.
- •History of malignant hypertension according to the definition of the 2018 ESC/ESH guidelines on hypertension.
- •Uncontrolled blood pressure despite the use of five antihypertensive drugs.
- •History of nephrotic syndrome.
- •History of hospitalization for hemorrhagic stroke in the past 3 months.
- •RAS blockers therapy previously stopped > 48h.
- •No affiliation to the French Health Care System "Sécurité Sociale".
- •Inability to obtain informed consent.
研究组 & 干预措施
1: discontinuation of RAS blocker therapy
discontinuation of RAS blocker therapy
干预措施: 1: discontinuation of RAS blocker therapy (Drug)
2: continuation of RAS blocker therapy
continuation of RAS blocker therapy
干预措施: 2: continuation of RAS blocker therapy (Drug)
结局指标
主要结局
Time to clinical improvement from day 0 to day 28 (improvement of two points on a seven-category ordinal scale, or live discharge from the hospital, whichever comes first)
时间窗: from day 0 to day 28 or hospital discharge
Time to clinical improvement from day 0 to day 28 (improvement of two points on a seven-category ordinal scale, or live discharge from the hospital, whichever comes first)
次要结局
- Number of days alive free of ICU admission until day28(at day28)
- Primary safety endpoint: major adverse cardiac events defined as the composite of cardiovascular death, myocardial infarction, stroke or acute heart failure at day 28(at day 28)
- Clinical status as assessed with the seven-category ordinal scale on days 7, 14 and 28.(at days 7, 14 and 28)
- Number of days alive outside hospital until day28(at day28)
- Number of days alive free of oxygen.(from day 0 to day 28 or hospital discharge)
- Number of days alive free of intensive-care unit (ICU) admission or mechanical Ventilation (invasive or non-invasive) until day28(at day28)
- Number of days alive free of mechanical ventilation (invasive or non-invasive) until day28(at day28)
- Rate of cardiovascular death at day 28(at day 28)
- Rate of all-cause mortality at day 28(at day 28)
- Number of days alive free of acute kidney injury until hospital discharge(at day 28 to hospital discharge)