Aspirin, Losartan and Simvastatin in Hospitalised COVID-19 Patients: a Multinational Randomised Open-label Factorial Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Death
研究概览
简要总结
The CRASH-19 trial is a multinational, open-label, factorial, randomised trial in adults hospitalised with suspected or confirmed acute COVID-19 infection.
详细描述
We will evaluate the effect of aspirin (150mg once daily), losartan (100mg once daily), and simvastatin (80mg once daily) in patients with COVID-19 infection.
Eligible patients will be randomly allocated to one of eight study arms (aspirin only; losartan only; simvastatin only; aspirin and losartan; aspirin and simvastatin; losartan and simvastatin; aspirin, losartan and simvastatin; standard care only). Trial treatments are given in addition to the usual standard of care at the study hospital.
Treatment will be started as soon as possible after randomisation and will continue until death, discharge or 28 days after randomisation, whichever occurs first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 40 years and older
- •with suspected or confirmed acute COVID-19 infection. Acute COVID-19 infection is suspected in the presence of a fever and at least one symptom of respiratory disease e.g. cough, difficulty breathing, signs of hypoxia. The clinician may suspect COVID-19 infection if i) the patient lives in or has recently travelled to an area with COVID-19 transmission; ii) the patient had recent contact with a confirmed or probable COVID-19 case, or iii) no alternative diagnosis fully explains the clinical presentation
- •requiring hospitalisation
排除标准
- •Women known to be pregnant
- •Patients hospitalised without symptoms of acute COVID-19 infection should not be recruited even if they test positive for COVID-19
- •Patients already receiving mechanical ventilation
- •Patients with a definite indication or contraindication for any of the trial treatments.
- •Patients who are very severely frail (completely dependent and approaching end of life who typically they could not recover even from a mild illness) or terminally ill should not be recruited.
研究组 & 干预措施
Aspirin
Aspirin 150mg once daily
干预措施: Aspirin (Drug)
Losartan
Losartan 100mg once daily. Dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.
干预措施: Losartan (Drug)
Simvastatin
Simvastatin 80mg once daily
干预措施: Simvastatin (Drug)
Aspirin and Losartan
Aspirin 150mg once daily and Losartan 100mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.
干预措施: Aspirin (Drug)
Aspirin and Losartan
Aspirin 150mg once daily and Losartan 100mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.
干预措施: Losartan (Drug)
Aspirin and Simvastatin
Aspirin 150mg once daily and Simvastatin 80mg once daily
干预措施: Aspirin (Drug)
Aspirin and Simvastatin
Aspirin 150mg once daily and Simvastatin 80mg once daily
干预措施: Simvastatin (Drug)
Losartan and Simvastatin
Losartan 100mg once daily and Simvastatin 80mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.
干预措施: Losartan (Drug)
Losartan and Simvastatin
Losartan 100mg once daily and Simvastatin 80mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.
干预措施: Simvastatin (Drug)
Aspirin, Losartan and Simvastatin
Aspirin 150mg once daily, Losartan 100mg once daily and Simvastatin 80mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.
干预措施: Aspirin (Drug)
Aspirin, Losartan and Simvastatin
Aspirin 150mg once daily, Losartan 100mg once daily and Simvastatin 80mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.
干预措施: Losartan (Drug)
Aspirin, Losartan and Simvastatin
Aspirin 150mg once daily, Losartan 100mg once daily and Simvastatin 80mg once daily. Losartan dose may be stopped or reduced if patient is hypotensive and can be restarted anytime during the treatment period.
干预措施: Simvastatin (Drug)
结局指标
主要结局
Death
时间窗: up to 28 days of randomisation
Cause of death will be described
次要结局
- Myocardial infarction(up to 28 days of randomisation)
- Congestive cardiac failure(up to 28 days of randomisation)
- Myocarditis(up to 28 days of randomisation)
- Viral pneumonitis(up to 28 days of randomisation)
- Acute renal failure(up to 28 days of randomisation)
- Sepsis(up to 28 days of randomisation)
- Stroke(up to 28 days of randomisation)
- Severe cardiac arrythmia(up to 28 days of randomisation)
- Respiratory failure including ARDS(up to 28 days of randomisation)
- Gastrointestinal bleeding(up to 28 days of randomisation)
- Receipt of non invasive or mechanical ventilation(up to 28 days of randomisation)
- Ability to self care at hospital discharge(up to 28 days of randomisation)