NCT04745442已完成2 期
Pilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19
Maimónides Biomedical Research Institute of Córdoba1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年4月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation
研究概览
简要总结
Pilot clinical trial, with a marketed drug -natural component of human plasma-, not approved for this indication, single-center, exploratory, open, randomized, controlled, to study the efficacy and safety of human Antithrombin in patients with confirmed COVID-19 disease and criteria high risk to develop SARS.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 and < 85 years
- •COVID-19 diagnosis confirmed.
- •Radiological image compatible with COVID-19
- •Present any of the following clinical-functional criteria considered RISK:
- •Respiratory distress: Tachypnea > 26 breaths / minute
- •PaO2 / FiO2 oxygenation index # 300
- •Alteration of one or more of the following parameters:
- •c.i. DD> 1,000 µg / L 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 c.vi. IL-6> 15 pg / mL
- •Direct or delegated verbal informed consent
排除标准
- •Signs of active bleeding
- •Immunosuppression by cancer or transplant
- •Intolerance or allergy to AT or its components
- •Pregnancy
研究组 & 干预措施
Best available treatment + Antithrombin
Experimental
The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19.
干预措施: Antithrombin + best available treatment (Drug)
Best available treatment
Active Comparator
The subject will be treated with the best available treatment for COVID-19.
干预措施: Best available treatment (Drug)
结局指标
主要结局
Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation
时间窗: At day 31 after randomization or hospital discharge (whichever occurs first)
Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation
次要结局
- Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.(At 24 and 48 hours.)
- Percentage of patients who suffer any adverse effect related to pharmacological intervention.(One month after pharmacological intervention.)
- Incidence of adverse events related to medication and its administration.(At day 31 after randomization or hospital discharge (whichever occurs first))
- Improvement of the analytical parameters: time (in days) until the tendency to normalization (decrease >= 20%) of DD, ferritin, LDH, PCR and IL-6; the criteria reached before will be used.(At day 31 after randomization or hospital discharge (whichever occurs first))
- Time to radiological improvement in radiological report.(At day 31 after randomization or hospital discharge (whichever occurs first))
- Time (in days) of non-invasive mechanical ventilation.(At day 31 after randomization or hospital discharge (whichever occurs first))
- Time (in days) of invasive mechanical ventilation.(At day 31 after randomization or hospital discharge (whichever occurs first))
- Incidence of B19 parvovirus infection(At day 31 after randomization or hospital discharge (whichever occurs first))
- Bleeding(At day 31 after randomization or hospital discharge (whichever occurs first))
- Time to clinical improvement (decreased risk of developing SARS or death)(At day 31 after randomization or hospital discharge (whichever occurs first))
- Incidence in the appearance of allergic type hypersensitivity(At day 31 after randomization or hospital discharge (whichever occurs first))
- Time (in days) until improvement in oxygenation: - Time until the SpO2 / FiO2 ratio exceeds the worst SpO2 / FiO2 prior to AT treatment.(At day 31 after randomization or hospital discharge (whichever occurs first))
- Mortality rate in hospital and one month after pharmacological intervention.(One month after pharmacological intervention.)
研究者
研究点 (1)
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