Pilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19
2021年2月8日 更新者：Maimónides Biomedical Research Institute of Córdoba
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.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
48
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Córdoba、西班牙、14004
- Hospital Universitario Reina Sofia
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Signs of active bleeding
- Immunosuppression by cancer or transplant
- Intolerance or allergy to AT or its components
- Pregnancy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Best available treatment + Antithrombin
The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19.
|
The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19.
|
|
有源比较器：Best available treatment
The subject will be treated with the best available treatment for COVID-19.
|
The subject will be treated with the best available treatment for COVID-19.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation
大体时间：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
|
At day 31 after randomization or hospital discharge (whichever occurs first)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to clinical improvement (decreased risk of developing SARS or death)
大体时间：At day 31 after randomization or hospital discharge (whichever occurs first)
|
Time (in days) to improvement in the National Early Warning (NEWS) Score 2. Defined as the time, in days, from the start of treatment a two-point improvement on this scale.
|
At day 31 after randomization or hospital discharge (whichever occurs first)
|
|
Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.
大体时间：At 24 and 48 hours.
|
Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.
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At 24 and 48 hours.
|
|
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.
大体时间：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 (in days) until improvement in oxygenation: - Time until the SpO2 / FiO2 ratio exceeds the worst SpO2 / FiO2 prior to AT treatment.
大体时间：At day 31 after randomization or hospital discharge (whichever occurs first)
|
Time until the absence of oxygen need to maintain a basal saturation >= 92%.
|
At day 31 after randomization or hospital discharge (whichever occurs first)
|
|
Time to radiological improvement in radiological report.
大体时间：At day 31 after randomization or hospital discharge (whichever occurs first)
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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.
大体时间：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.
大体时间：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)
|
|
Mortality rate in hospital and one month after pharmacological intervention.
大体时间：One month after pharmacological intervention.
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Mortality rate in hospital and one month after pharmacological intervention.
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One month after pharmacological intervention.
|
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Percentage of patients who suffer any adverse effect related to pharmacological intervention.
大体时间：One month after pharmacological intervention.
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Percentage of patients who suffer any adverse effect related to pharmacological intervention.
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One month after pharmacological intervention.
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Incidence of adverse events related to medication and its administration.
大体时间：At day 31 after randomization or hospital discharge (whichever occurs first)
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Incidence of adverse events related to medication and its administration.
|
At day 31 after randomization or hospital discharge (whichever occurs first)
|
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Incidence in the appearance of allergic type hypersensitivity
大体时间：At day 31 after randomization or hospital discharge (whichever occurs first)
|
Incidence in the appearance of Acne, Generalized urticaria, Chest tightness, Dyspnoea, Hypotension and/or Anaphylaxis.
|
At day 31 after randomization or hospital discharge (whichever occurs first)
|
|
Incidence of B19 parvovirus infection
大体时间：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
大体时间：At day 31 after randomization or hospital discharge (whichever occurs first)
|
Incidence of Bleeding
|
At day 31 after randomization or hospital discharge (whichever occurs first)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ángel Salvatierra, MD、Hospital Universitario Reina Sofia
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年4月27日
初级完成 (实际的)
2020年12月20日
研究完成 (实际的)
2021年1月15日
研究注册日期
首次提交
2021年2月8日
首先提交符合 QC 标准的
2021年2月8日
首次发布 (实际的)
2021年2月9日
研究记录更新
最后更新发布 (实际的)
2021年2月9日
上次提交的符合 QC 标准的更新
2021年2月8日
最后验证
2021年2月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ANTITROMBINA
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 共享时间框架
The information will be provided after the results are published in a journal.
IPD 共享访问标准
Upon request to uicec@imibic.org
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.