Nebulized Furosemide for Pulmonary Inflammation in Intubated Patients With COVID-19 - A Phase 2/3 Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Improvement in pulmonary gas exchange
研究概览
简要总结
This double-blind, placebo-controlled, randomized, parallel-group phase 2/3 study will study the utility of nebulized furosemide for pulmonary inflammation in Intubated, mechanically ventilated Patients with COVID-19.
详细描述
This double-blind, placebo-controlled, randomized, parallel-group phase 2/3 study will study the utility of nebulized furosemide for pulmonary inflammation in Intubated, mechanically ventilated Patients with COVID-19. The primary objective of the study is to establish the efficacy and safety of nebulized furosemide for the treatment of respiratory failure secondary to COVID-19 infection requiring invasive mechanical ventilation. The secondary objective is to delineate the anti-inflammatory properties of furosemide in COVID- 19 patients using pharmacokinetic / pharmacodynamic analysis. The duration of the intervention will be up to 28 days of intervention and patients will be followed till 60 days post randomization. Participants will be randomized to either: Intervention Group: 40 mg furosemide per dose, given by nebulization (4 mL of 10 mg/mL furosemide in 0.9% saline solution) over 30 mins four times daily (Q6H) for up to 28 days OR Control Group: placebo, given by nebulization (4 mL of 0.9% saline solution) over 30 mins four times daily for up to 28 days. One hundred and forty-four (144) evaluable patients will be enrolled in the Phase 2 study. If evidence of efficacy is found in the Phase 2 portion, these patients will be enrolled in the Phase 3 study which aims to recruit 640 patients total (496 additional patients to the phase 2 patients).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with respiratory failure secondary to COVID-19 (SARS-CoV-2) infection/pneumonia requiring invasive mechanical ventilation
- •Duration of mechanical ventilation less than 48 hours as measured from the time of randomization
- •If female, must not be pregnant at the time of enrollment as determined by a serum or urine pregnancy test
排除标准
- •Known history of severe chronic pulmonary disease (e.g., preinfection requirement for home oxygen therapy or presence of chronic hypercapnia (PaCO2< 50 mm Hg); mild -moderate disease is still eligible in the absence of chronic hypercapnia or need for chronic oxygen therapy)
- •In the opinion of the PI, unlikely to survive for >48 hours from time of enrollment
- •Enrollment in another trial of anti-inflammatory therapies for COVID-
- •Known allergy to furosemide or sulfonamide agents
研究组 & 干预措施
Inhaled Furosemide
40 mg furosemide per dose, given by nebulization (4 mL of 10 mg/mL furosemide in 0.9% saline solution) over 30 mins four times daily (Q6H) for up to 28 days
干预措施: Nebulized Furosemide (Drug)
Nebulized Saline
Placebo, given by nebulization (4 mL of 0.9% saline solution) over 30 mins four times daily (Q.I.D.) for up to 28 days
干预措施: Nebulized Saline (Drug)
结局指标
主要结局
Improvement in pulmonary gas exchange
时间窗: Study Day 6
Improvement in oxygenation as determined by a standardized PaO2/FiO2 ratio
Requirement for mechanical ventilation
时间窗: Baseline to day 28
Number of ventilator-free days in the first 28 days after enrollment
次要结局
- Mortality(Day 60 post enrollment)
- Requirement for supplemental oxygen(To day 28 post enrollment)
- Duration of ICU Stay(Up to 60 days post enrollment)
- Length of hospitalization(Up to 60 days post enrollment)
- Inhalation adverse events(Up to day 28)
- Adverse events(Up to 60 days post enrollment)
研究者
Dr. John Muscedere
Professor of Medicine, Queen's University
Queen's University