Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 18
- 主要终点
- Reduction of suspicion of systemic thrombotic symptomatic events
研究概览
简要总结
The main objective is to evaluate the efficacy and safety of three doses of tinzaparin (prophylactic, intermediate and therapeutic) in hospitalized patients with COVID-19 pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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, PCR and/or Antigens Test + SARS-CoV-2 infection or (presence of infiltrate compatible with Chest X-ray or TC)
- •Patients with, at least, one of the following evolution disease risk criteria:
- •Sat 02<94%
- •Need for oxygen therapy or pAO2/FiO2<300mmHg or estimated PaO2/FiO2 based on SpO2/FiO2<300 mmHg.
- •DD>1000µg/L
- •PCR >150mg/L
- •IL6 >40pg/ml
- •Age > 18 years
- •Weight 50-100 Kg
- •After receiving oral and written information about the study, patient must give Informed Consent duly signed and dated before performing any activity related to the study.
排除标准
- •Patients who need mechanical ventilation (invasive or non-invasive), high flow nasal cannula or admission to ICU at the moment of randomization.
- •Current diagnosis of acute bronchial asthma attack.
- •History or clinical suspicion of pulmonary fibrosis.
- •Current diagnosis or suspicion of pulmonary thromboembolism or deep vein thrombosis.
- •Patients who need anticoagulant treatment due to previous venous or arterial thrombotic disease, or due to atrial fibrillation.
- •Patients with pneumonectomy or lobectomy.
- •Renal failure with Glomerular filtration <30 ml/min/1.73m2
- •Patients with contraindication for anticoagulant treatment.
- •Congenital bleeding disorders.
- •Hypersensitivity to tinzaparin or UFH or some of its excipients.
- •History of heparin-induced thrombocytopenia.
- •Active bleeding or situation that predispose to bleeding.
- •Moderate or severe anaemia (Hb<10 g/dl)
- •Low platelet count < 80000/µl
- •Patients with life expectancy less than 3 months due to primary disease evaluated by the physician.
- •Patients currently intubated or intubated between the screening and the randomization.
研究组 & 干预措施
Tinzaparin 4500 UI/day
Procedure: Tinzaparin 4500 UI/day SC until hospital discharge.
干预措施: Tinzaparin (Drug)
Tinzaparin 100 UI/Kg/day
Procedure: Tinzaparin 100 UI/Kg/day SC until hospital discharge.
干预措施: Tinzaparin (Drug)
Tinzaparin 175 UI/Kg/day
Procedure: Tinzaparin 175 UI/Kg/day SC until hospital discharge.
干预措施: Tinzaparin (Drug)
结局指标
主要结局
Reduction of suspicion of systemic thrombotic symptomatic events
时间窗: 30 days
Reduction of symptomatic thrombotic events: rate of venous thromboembolism confirmed by objective test.
Combined variable that includes outcomes 2, 3 and 4 detailed below
时间窗: 30 days
Combined variable that includes outcomes 2, 3 and 4 detailed below (reduction of suspicion of systemic thrombotic symptomatic events and/or need for mechanical ventilation and/or death at day 30 after randomization).
Use of Mechanical ventilation invasive or non invasive including high flow nasal cannula oxigen
时间窗: 30 days
Mechanical ventilation (invasive or non-invasive) free survival.
Overall survival at 30 days.
时间窗: 30 days
Overall survival at 30 days: number of deaths.
次要结局
- Number of bleedings and adverse reactions(90 days)