Management of Renin-Angiotensin-Aldosterone System Blockade in Patients Admitted in Hospital With Confirmed Coronavirus Disease (COVID-19) Infection: The McGill RAAS-COVID-19 Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Global rank score
研究概览
简要总结
Coronavirus disease (COVID-19) related pneumonia significantly impact patients with underlying cardiovascular (CV) conditions. Animal studies suggest that drugs commonly used to treated CV diseases may increase the ability of COVID-19 to infect cells. The RAAS-COVID-19 trial aims to assess whether temporarily holding these CV drugs in patients who are admitted with COVID-19, versus continuing them, in patients admitted with COVID-19 can impact short term outcomes.
详细描述
Open-label, pragmatic, randomized, study of approximately 40 adults. The following groups of participants will be considered: i) within 48 hours of diagnosis of COVID-19; ii) who have received a diagnosis of COVID-19 from another facility and are within 48 hours of transfer to a study recruitment site (Royal Victoria Hospital, Montreal General Hospital, and Jewish General Hospital [all in Montreal, Quebec, Canada]). Participants will be randomized 1:1 to an upfront temporary discontinuation) of RAAS inhibition for the duration of the hospitalization (and to consider re-initiate after day 7 of admission or on discharge) versus a strategy continuation of RAAS inhibition. Re-initiation of held RAAS inhibition will be based on treating team's clinical judgement. The RAAS-COVID-19 RCT will evaluate whether an upfront strategy of temporary discontinuation of RAAS inhibition compared to the continuation of RAAS inhibition among patients admitted with established COVID-19 infection and on chronic RAAS inhibition therapy impacts short term clinical outcomes and biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The patient and the treating doctor will be informed of the assigned treatment.
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.
- •Hospitalization with a Covid-19 infection
- •Chronically treated with RAAS 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
- •Participants are within 48 hours of diagnosis of COVID-19 or have received a diagnosis of COVID-19 from another facility and are within 48 hours of transfer to a study recruitment site
排除标准
- •Shock requiring vasoactive agents.
- •Requiring invasive mechanical ventilation.
- •History of malignant hypertension
- •Use of five or more antihypertensive drugs.
- •History of heart failure with reduced ejection fraction
- •History of hospitalization for acute heart failure in past 3 months
- •History of hospitalization for hemorrhagic stroke in the past 3 months.
- •History of CKD with an eGFR <45 ml/min/1.73m2
- •History of COPD GOLD III/IV
- •History of end-stage dementia
- •History of active liver cirrhosis
- •RAAS blockers therapy previously stopped > 48h.
- •Anticipated discharge in less than 24 hours.
- •History of current active cancer receiving chemotherapy
- •Inability to obtain informed consent.
结局指标
主要结局
Global rank score
时间窗: Baseline - day 7
The primary end point is a global rank score which is applied to all participants. The global rank sum is based on the following endpoints (and corresponding score): Death (7); Transfer to ICU for Invasive ventilation (6); Transfer to ICU for other indication (5); Non-fatal MACE (Any of the following - MI, Stroke, Acute HF, new onset Afib) (4); Length of stay \> 4 days (3); Development of acute kidney injury (\>40% decline in eGFR or doubling of serum Cr) (2); Urgent intravenous treatment for high blood pressure/hypertensive crisis (2); \>30% Increase in baseline high sensitivity troponin (1); \>30% increase in baseline BNP (1); Increase in baseline CRP to 48 hours \>30%(1); Lymphocyte count drop \>30% (1). The primary endpoint will be assessed from baseline to day 7 (or day of discharge if occurs before day 7). Participants will receive a weighted score depending on the events experienced. The global rank sum score will then be averaged and compared between treatment arms.
次要结局
未报告次要终点
研究者
Abhinav Sharma
Cardiologist
McGill University Health Centre/Research Institute of the McGill University Health Centre