Annexin A5 in Patients With Severe COVID-19 Disease: A Single Centre, Randomized, Double-blind, Placebo-controlled Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Enrollment
研究概览
简要总结
Randomized, double-blind, placebo-controlled trial comparing 2 doses of SY-005 (recombinant human Annexin A5) to placebo in patients with severe coronavirus 2019 disease in a single hospital centre with 2 intensive care units
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years
- •Positive test for SARS-CoV-2 virus (anytime during current illness episode)
- •Admitted to intensive care for organ failure support (at least one of vasopressor, non-invasive or invasive ventilation)
排除标准
- •Known allergy to any of the ingredients or components of the investigational product
- •Known pregnancy
- •Moribund and not expected to survive beyond 24 hours
- •Known or suspected risk for serious bleeding complications (note that Disseminated Intravascular Coagulopathy (DIC) is an expected finding in patient with sepsis and COVID-19 disease and is not an exclusion criterion on its own)
- •Acute or chronic renal failure (dialysis dependent)
研究组 & 干预措施
Placebo
Normal saline, 50 ml infusion over 30 minutes every 12 hours for 7 days
干预措施: Placebo (Drug)
Low dose
50 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days
干预措施: recombinant human annexin A5 (Drug)
High dose
100 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days
干预措施: recombinant human annexin A5 (Drug)
结局指标
主要结局
Enrollment
时间窗: 12 months
Participants enrolled per site per month with success defined as enrollment \>= 50% of screened eligible patients
Protocol adherence
时间窗: 7 days
Delivery of investigational product within 1 hour of scheduled dose; success defined as \>= 90%
Data completeness
时间窗: 12 months
Case Report Forms completed with \<10% missing data after verification and monitoring
次要结局
- Individual organ function scores at 30 days measured with SOFA(30 days)
- Individual organ function scores at EOT measured with MODS(30 days)
- Organ function at end of treatment measured with SOFA(7 days)
- Elimination half-life of annexin A5 (SY-005)(1 day)
- Ventilator-free days(30 days)
- ICU-free days(30 days)
- Number of participants with persistent organ dysfunction(30 days)
- Number of participants with anti-annexin A5 antibodies(21 days)
- Individual organ function scores at EOT measured with SOFA(30 days)
- Individual organ function scores at 30 days measured with MODS(30 days)
- Mortality at 60 days(60 days)
- Hospital mortality(60 days)
- Plasma annexin A5 levels daily days 1-8 (treatment period) and on day 14(14 days)
- Maximum plasma concentration (Cmax) of annexin A5 (SY-005)(1 day)
- Organ failure(30 days)
- Organ function at end of treatment measured with Multiple Organ Dysfunction Score (MODS)(7 days)
- Number of serious adverse events (SAE)(60 days)