NCT04466670Unknown2 期
Dynamics of Hemostatic Parameters in COVID-19 and Comparison of Intervention Strategies Through Adaptive Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 379
- 试验地点
- 1
- 主要终点
- Hospital discharge - alive / death
研究概览
简要总结
Hypercoagulability has been demonstrated in COVID-19, leading to respiratory distress and increased mortality. This is an adaptive clinical trial to compare the efficacy and safety of two experimental strategies in patients with COVID-19: ASA or inhaled UFH associated with standard VTE prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Adult ≥18 years of age at time of enrollment
- •Subjects with a positive COVID-19 diagnosis by RT-PCR or serologic testing
- •Subject (or legally authorized representative) must be willing, understanding and able to provide written informed consent.
- •Only at phase 2:
- •onset of symptoms must not exceed 4 weeks
- •ICU patients
- •PaO2 to FiO2 ratio < 200
排除标准
- •Indications for therapeutic anticoagulation
- •History of chronic lung disease oxygen dependent
- •Pregnancy
- •Death considered imminent and inevitable within 24 hours
- •Patients under exclusive palliative care
- •Participation in another trial of investigational drug
- •Body weight < 40 Kg
- •Total bilirubin > 20 mg/dL
- •Severe active bleeding
- •Persistent GI bleeding
- •Known allergy to UFH or LMWH
- •History of heparin-induced thrombocytopenia (HIT) within the past 6 months
- •Exclusion criteria at phase 1
- •Platelet count < 25,000/mm3
- •Bacterial endocarditis
- •Exclusion criteria at phase 2
- •Platelet count < 50,000/mm3
- •History of surgery in the last 30 days
- •Intervention A: allergy to ASA and long-term use of antiplatelet drug
- •Intervention B: inhaled nitric oxide use
研究组 & 干预措施
phase 2B
Experimental
inhaled unfractionated heparin
干预措施: Unfractionated heparin nebulized (Drug)
phase 2A
Experimental
Acetylsalicylic acid
干预措施: acetylsalicylic acid (Drug)
Placebo
Placebo Comparator
Placebo arm for Phase 2A
干预措施: acetylsalicylic acid (Drug)
结局指标
主要结局
Hospital discharge - alive / death
时间窗: 30 days
Number of COVID-19 positive patients who are alive within 30 days of symptoms onset
次要结局
- Length of renal replacement therapy free days(30 days)
- Length of mechanical ventilation free days(30 days)
- Number of documented venous thromboembolism or arterial thrombosis(3 months)
研究者
Vanderson Geraldo Rocha
Full professor
University of Sao Paulo General Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Role of Hematological Parameters in the Stratification of COVID-19 Disease SeverityCovid19NCT04670328FMH College of Medicine and Dentistry101
Unknown
不适用
Hemostatic Profile in Patients Affected by COVID-19Covid19ThrombosisNCT04595110ANNA FALANGA400
Unknown
不适用
Study of Hemostasis in Case of Severe COVID-19COVID-19 InfectionNCT04359992University Hospital, Strasbourg, France50
Unknown
不适用
Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 InfectionCovid-19Endothelial DysfunctionThrombosisCritically IllNCT04357847University Hospital, Rouen100
已完成
不适用
Platelet Aggregation in COVID-19 PatientsCOVID-19NCT06097429Mansoura University75