INHALEd Unfractionated HEParin for the Treatment of Hospitalised Patients With COVID-19 Meta-trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 5
- 主要终点
- Intubation rate
研究概览
简要总结
This meta-trial is a prospective collaborative individual participant data meta-analysis of randomised controlled trials and early phase studies. Individual studies will be conducted in multiple countries, including Australia, the UK, the USA, Ireland, Argentina, Brazil and Egypt.
Adult patients admitted to the hospital with confirmed SARS-CoV-2 infection, who do not require immediate mechanical ventilation, will be randomised to inhaled nebulised heparin or standard care for up to 21 days or until the patient has no respiratory symptoms. All studies will collect a minimum core dataset. The primary outcome for the meta-trial is the proportion of patients who receive invasive mechanical ventilation censored at day 28. Individual studies may have specific outcome measures in addition to the core set.
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
- •Patients admitted to hospital with COVID-19
- •No immediate requirement for mechanical ventilation (points 3-5 on the WHO ordinal scale)
- •Age equal to or greater than 18
- •Able to provide informed consent
排除标准
- •Pregnant women
- •Known allergy to Heparin
- •Participant in another clinical trial that is not approved for joint enrollment.
- •APTT> 120 seconds, not due to anticoagulant therapy.
- •Platelet count <20 x 109 per L
- •Lung bleeding.
- •Uncontrolled bleeding
- •Advanced neurological impairment
- •Advanced oncological disease
研究组 & 干预措施
Inhaled heparin
Inhaled nebulised unfractionated heparin in addition to standard care Dose 25,000 IU every 6 hours for up to 21 days
干预措施: Unfractionated heparin (Drug)
结局指标
主要结局
Intubation rate
时间窗: Day 28
Proportion of patients requiring invasive mechanical ventilation
次要结局
- WHO ordinal scale COVID19(Day 7)
- Oxygenation(Day 7)
研究者
Frank van Haren
Professor
Australian National University