ISRCTN15851697进行中（未招募）未知
HElping Alleviate the Longer-term consequences of COVID-19 (HEAL-COVID): a national platform trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 1,245
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Greater than or equal to 18 years of age
- •2. Hospitalised patient approaching the end of their admission (estimated planned discharge at any point within the next 5 days)
- •3. SARS-CoV-2 infection-associated disease (laboratory-confirmed SARS-CoV-2 infection on this hospital admission)
- •4. Written informed consent obtained from participant or participant’s legal representative
排除标准
- •Generic exclusion criteria:
- •1. Known hypersensitivity to trial medication (patient will be excluded from specific arm)
- •2. Long-term pre-hospital administration of trial medication (patient will be excluded from specific arm
- •3. Previous medical history of significant complication with trial medication or trial medication drug class
- •4. 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.
- •5. Participant not expected to survive 14 days from hospital discharge
- •Apixaban exclusion criteria:
- •1. Active clinically significant bleeding
- •2. Childs-Pugh C, or worse, chronic liver disease
- •3. Known pregnancy or breast-feeding
- •4. Coagulopathy: INR greater than 1.7 or platelet count below 70
- •5. Lesion or condition considered by the investigator as a significant risk factor for major bleeding. This may include recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities
- •6. Concomitant treatment following discharge with any other anticoagulant agent, including but not limited to unfractionated heparin, low molecular weight heparins (e.g. enoxaparin, dalteparin), heparin derivatives (e.g. fondaparinux), and other oral anticoagulants (e.g. warfarin, rivaroxaban, dabigatran
- •Atorvastatin exclusion criteria:
- •1. Childs-Pugh C, or worse, chronic liver disease
- •2. Unexplained persistent elevation of serum transaminases exceeding five times the upper limit of normal
- •3. Known pregnancy or breast-feeding.
- •4. Treatment with the hepatitis C antivirals glecaprevir/pibrentasvir. Ciclosporin, or HIV protease inhibitors
- •5. Serum creatine kinase concentration exceeding 10 times the upper limit of normal.
- •6. Long-term pre-hospital administration of any statin therapy
研究者
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