A Randomized, Single-blind Study With a Parallel Control Group on the Efficacy and Safety of Bemiparin at Therapeutic Dose vs. Prophylactic Dose in Patients Hospitalized for COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Proportion of patients that worsen
研究概览
简要总结
The 2019 coronavirus disease (Covid-19) is a new disease caused by the SARS-CoV2 virus of which many things are not yet known. Among others, there is a need to define the best therapeutic strategy to treat Covid-19, improving patients survival and reducing complications in its management, for which many different types of treatments are being tested.
The drug being tested in this clinical trial is called bemiparin. Bemiparin is a drug authorized as a prevention and as a treatment for deep vein thrombosis (blood clots in one or more veins, generally in the legs) and venous thromboembolism (when the clot can detach and lodge in other organs such as the lungs). Covid-19 patients have been shown to be at increased risk of developing clotting problems such as those described above.
In this context, this clinical trial is being carried out to find out if certain doses of bemiparin can contribute to better management of the disease.
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
- Single (Participant)
盲法说明
Subjects will be blinded to the dosing regimen (treatment dose or prophylactic dose).
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
- •Informed consent.
- •Age of 18 years or more.
- •Patient with suspected COVID-19 and who meets hospitalization criteria.
- •D-dimer> 500 ng / ml.
- •Clinical characteristics highly compatible with SARS-CoV-2 infection and confirmation by RT-qPCR at baseline or in the second sample in case of a first negative test and clinical suspicion remains.
- •Patient admitted to hospital
排除标准
- •ICU admission criteria.
- •Need for invasive or not invasive mechanical ventilation
- •Creatine clearance <30 ml / min (Cockroft-Gault).
- •Severe liver or pancreatic function disorder.
- •Acute bacterial endocarditis and slow endocarditis.
- •Patient previously anticoagulated (although it is allowed to have received heparin at a previous low dose without time limit).
- •Patient with high hemorrhagic risk due to previous medical-surgical history.
- •Severe thrombocytopenia (<80,000 platelets/ mm3) or known history of heparin-induced thrombocytopenia.
- •Active bleeding or increased risk of bleeding from haemostasis disorders or from organic lesions that are liable to bleed (eg, active peptic ulcer, hemorrhagic stroke, aneurysms, or brain malignancies).
- •Damage or surgical interventions in the central nervous system, eyes and ears that have taken place in the last 2 months.
- •Simultaneous participation in another clinical trial that could have a conflictive interaction with what it is intended to evaluate.
- •Any situation that in the opinion of the researcher could interfere with the treatment or with the evolution of the patient.
研究组 & 干预措施
Experimental - therapeutic bemiparin dose
Sub-cutaneous dose of bemiparin at therapeutic dose for 10 days
干预措施: Bemiparin (Drug)
Control - prophylactic bemiparin dose
Sub-cutaneous dose of bemiparin at prophilactic dose for 10 days
干预措施: Bemiparin (Drug)
结局指标
主要结局
Proportion of patients that worsen
时间窗: Day 10 +/- 1
Combined worsening variable. Presence of any of the following will be considered worseing: 1. Death. 2. ICU admission. 3. Need for either non-invasive or invasive mechanical ventilation. 4. Progression to moderate / severe respiratory distress syndrome according to objective criteria (Berlin definition). 5. Venous thromboembolism (deep vein thrombosis or pulmonary embolism) or arterial (acute myocardial infarction or stroke).
次要结局
- Proportion of subjects that requires admission to the ICU(From study start to day 28)
- Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline(From study start to day 28)
- Clinically relevant major and non major hemorrhages.(From study start to day 28)
- Mortality from any cause at day 28(Day 28)
- Proportion of subjects requiring non-invasive mechanical ventilation(From study start to day 28)
- Proportion of subjects requiring invasive mechanical ventilation.(From study start to day 28)
- Proportion of subjects with some organ failure(From study start to day 28)
- Ferritin score(From study start to day 28)
- D-dimer modification score(From study start to day 28)
- Adverse events (total and serious).(From study start to day 28)
- Proportion of subjects with pathological angioTAC(At day 10 +/-1)
- Related adverse events (total and serious).(From study start to day 28)
- Proportion of subjects with improvement in chest radiography(At day 10 +/-1)
- Proportion and median hospital discharge between patients in both groups.(From study start to day 28)
- Titration score(From study start to day 28)