EUCTR2020-001659-42-ES进行中（未招募）1 期
Pilot study of antithrombin as prophylaxis of acute respiratory distress syndrome in patients with COVID-19
Fundación para la Investigación Biomédica de Córdoba0 个研究点目标入组 46 人开始时间: 2020年4月20日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 and <85 years
- •2. Diagnosis confirmed by COVID-19 PCR
- •3. Radiological image compatible with COVID-19
- •4. Present any of the following clinical-functional criteria considered RISK:
- •4.a. Respiratory distress: Tachypnea> 26 breaths / minute
- •4. b. PaO2 / FiO2 oxygenation index = 300
- •4.c. Alteration of one or more of the following parameters:
- •4.c.i. DD> 1,000 µg / L
- •4.c.ii. Ferritin> 800 ng / mL
- •4.c.iii. Lymphocytes <800 cells / µL
- •4.c.iv. PCR> 100 mg / L
- •4.c.v. LDH> 500 U / L
- •4.c.vi. IL-6> 15 pg / mL
- •5. Direct or delegated verbal informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •1. Signs of active bleeding
- •2. Immunosuppression by cancer or transplant
- •3. Intolerance or allergy to AT or its components
- •4. Pregnancy
研究者
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