Tenecteplase With Concomitant Anticoagulation for Severe Acute Respiratory Failure in Patients With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of Participants Free of Respiratory Failure
研究概览
简要总结
This is a placebo-controlled, double blind, randomized, Phase II dose escalation study intended to evaluate the potential safety and efficacy of tenecteplase for the treatment of COVID-19 associated respiratory failure. The hypothesis is that administration of the drug, in conjunction with heparin anticoagulation, will improve patients' clinical outcomes.
详细描述
Patients with COVID-19 who suffer from acute hypoxemic respiratory failure have a poor prognosis. COVID-19 has been associated with a hyperinflammatory and hypercoagulable state, leading to a range of thromboembolic complications from pulmonary embolism to ischemic stroke. Furthermore, emerging data suggest that the associated acute respiratory failure is, at least in part, due to pulmonary vascular disease caused by micro- and/or macro-emboli, creating pulmonary vascular shunting and dead-space ventilation. In this placebo-controlled, double blind, randomized, Phase II dose escalation study, we plan to evaluate the clinical efficacy and safety of low-dose IV bolus tenecteplase together with anticoagulation compared with control patients on therapeutic anticoagulation alone in hospitalized adults diagnosed with COVID-19 respiratory failure with elevated D-dimer. We believe these patients can be successfully treated without significantly increasing the risk of major bleeding while improving recovery rates, shorten hospitalization time, and perhaps ultimately prove to improve survival.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Patients and study investigators will be blinded to subject treatment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tenecteplase
First 20 patients randomized to treatment will receive tenecteplase 0.25 mg/kg (maximum 25 mg). Last 20 patients randomized to treatment will receive tenecteplase 0.50 mg/kg (maximum 40 mg).
干预措施: Tenecteplase (Drug)
Placebo
Placebo control
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Free of Respiratory Failure
时间窗: 28 Days
The number of patients free of respiratory failure defined as not requiring high flow nasal cannula, non-rebreather, noninvasive positive pressure ventilation, or mechanical ventilation at 28 days
Number of Participants With Occurrences of Bleeding
时间窗: 28 days
Safety as assessed by number of participants with occurrences of intracranial bleeding or major bleeding
次要结局
- Number of Participants With Need for Renal Replacement Therapy(28 days)
- Number of Vasopressor-free Days(28 days)
- Number of Participants With In-hospital Deaths at 14 Days(14 days)
- Number of Participants With Death at 28 Days(28 days)
- Number of Vasopressor Doses at 24 Hours(24 hours and 72 hours)
- P/F Ratio(24 hours and 72 hours)
- Number of ICU-free Days(28 days)
- Hospital Length of Stay(up to 29 days)
- Number of Ventilator-free Days(28 days)
- Number of Respiratory Failure-free Days(28 days)
- Number of Participants With New-onset Renal Failure(28 days)
研究者
Hooman Poor
Assistant Professor of Medicine
Icahn School of Medicine at Mount Sinai