NCT04334629撤回4 期
Lipid Ibuprofen Versus Standard of Care for Acute Hypoxemic Respiratory Failure Due to COVID-19: a Multicentre, Randomised, Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to mechanical ventilation
研究概览
简要总结
The study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with SARS-CoV-2 infections.
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
- Double (Investigator, Outcomes Assessor)
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
- •Male or female patients aged 18 years and above;
- •Hospitalised;
- •Confirmed or suspected SARS-CoV-2 infection;
- •National Early Warning Score (NEWS2) greater than or equal to 3 in a single parameter or NEWS2 > 5 overall;
- •Acute hypoxemic respiratory failure: PaO2/FiO2 ratio less than or equal to 300 OR SpO2/FiO2 ratio < 315 (Kigali Modification)
- •Provision of written informed consent by the patient OR by the patient's Legal Representative OR professional consultee.
排除标准
- •Any of the following contraindications to ibuprofen:
- •A known hypersensitivity to ibuprofen or any other constituent of the medicinal product;
- •Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs);
- •Patients with a history of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs;
- •Patients with severe hepatic failure;
- •Patients with acute renal failure;
- •Patients with severe heart failure.
- •Participation in any other investigational drug products less than 30 days prior to study enrolment;
- •Glasgow Coma Score < 12;
- •Patients who cannot swallow oral capsules;
- •Pregnant or lactating women;
- •Any medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial.
研究组 & 干预措施
Standard of care plus lipid ibuprofen
Experimental
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Time to mechanical ventilation
时间窗: 14 days
Time to mechanical ventilation (or need of)
Disease progression
时间窗: 14 days
Worsening respiratory failure; defined using severity of hypoxaemia using \[PaO2/FiO2 ratio OR SpO2/FiO2 ratio\]
次要结局
- Overall survival(28 days)
- Reduction in proportion of patients who require ventilation(28 days)
- Reduction in duration of ventilation(28 days)
- Increase in ventilator-free days(28 days)
- Reduction in length of Critical Care stay(28 days)
- Reduction in length of Hospital stay(28 days)
- Modulation of serum pro- and anti-inflammatory cytokines(28 days)
研究者
研究点 (1)
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