Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 804
- 试验地点
- 1
- 主要终点
- Clinical improvement
研究概览
简要总结
There is an urgent need for effective therapies against the novel COVID-19 virus. Studies have shown that amiodarone and verapamil can interfere with coronavirus entry and amplification by blocking ion channels. ReCOVery-SIRIO is a randomized study to investigate amiodarone or verapamil compared with usual care in symptomatic patients hospitalized with confirmed COVID-19 infection.
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
Clinical events will be validated blindly by an independent clinical event committee (CEC) unaware of the treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients with confirmed COVID-19 infection and symptoms, with an oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2) > 200.
排除标准
- •Acute respiratory distress syndrome (ARDS)
- •Contraindications for or known hypersensitivity to amiodarone or calcium channel blockers
- •Long QT syndrome
- •Prolonged baseline QTc interval (≥450 ms).
- •Cardiogenic shock or severe hypotension (SBP< 90 mmHg)
- •Severe left ventricle dysfunction (left ventricular ejection fraction ≤35%)
- •Severe sinus - node dysfunction with marked sinus bradycardia
- •2nd/3rd degree heart block
- •Bradycardia without pacemaker that has caused syncope
- •History of severe dysthyroidism
- •A-Fib/flutter conducted via accessory pathway (ie,Wolff -Parkinson-White)
研究组 & 干预措施
Amiodarone
Amiodarone - administered intravenously
Bolus of 150 mg is given over a minimum of 10 min, with subsequent continuous infusion of 1 mg/min for 6 h, next continuous infusion of 0.5 mg/min for 18 h, then switch to oral administration.
Oral administration
200 to 400 mg/day (adjust dosage based on cardiac response and age) up to discharge.
干预措施: Amiodarone (Drug)
Verapamil
Verapamil - administered intravenously
Bolus of 0.075-0.15 mg/kg (5-10 mg) over at least 3 minutes, then switch to oral administration.
Oral administration
120 to 480 mg/day in divided doses every 6-8 hours (adjust dosage based on cardiac response and age) up to discharge.
干预措施: Verapamil (Drug)
结局指标
主要结局
Clinical improvement
时间窗: Randomization to day 15
Time to first occurrence of clinical improvement assessed on a seven category scale ranging from 1 to 7
次要结局
- Cardiac troponins(7, 10 and 15 days after randomization)
- Clinical improvement(Randomization to day 7 and 28)
- Mortality(Randomization to day 28)
- Time to resolution of fever(Randomization to day 28)
- Tachyarrhythmias(Randomization to day 28)
- Time to clinical improvement from admission using the 7-point ordinal scale(Randomization to day 28)
- Change in NEWS2 score(Randomization to day 7 and 15)
- Duration of hospitalization(Randomization to day 28)
- PO2/FIO2(Randomization to day 7 and 15)
研究者
Eliano Pio Navarese
Prof Eliano P. Navarese, MD, PhD
Nicolaus Copernicus University