NCT04422509已完成1 期
Lanadelumab for Treatment of COVID-19 Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- oxygen
研究概览
简要总结
So far little is very few drugs have demonstrated positive results for treatment of COVID19.
Recently the researchers have shown that the use of icatibant in COVID-19 results in a potent decrease in oxygen use. Yet the effect of the three dosages as according to the label dose was insufficient to maintain the clinical improvement in a small group of patients. The researchers argue that with the use of lanadelumab a more lasting effect can be reached due to its longer half life.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is SARS-COV2 positive (PCR)
- •Without oxygen a saturation below 90%
- •At least 3L/min oxygen dependent
- •Patient is 16 years and older
排除标准
- •Has previously participated in this study
- •Acute myocardial or cerebral ischemic event at time of enrolment
- •Receiving ACE or ARB inhibitor or comparable drugs that is specified as an intervention in this domain as a usual medication prior to this hospitalization will exclude a patient from receiving that agent
- •A baseline alanine aminotransferase or an aspartate aminotransferase that is more than five times the upper limit of normal
- •Patient is known hypersensitive to full human monoclonal antibodies
- •Patient is pregnant or breast feeding
结局指标
主要结局
oxygen
时间窗: 2 weeks
oxygen use in L/min
次要结局
- adverse events(2 weeks)
研究者
研究点 (4)
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