A Phase 3, Prospective, Randomized, Open Label, Comparative, Clinical Study To Evaluate Efficacy And Safety Of Ulinastatin Plus Standard-Of-Care Compared To Standard-Of-Care In Treatment Of Acute Respiratory Distress Syndrome (ARDS) In Hospitalized COVID-19 Infection Patient
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 13
- 主要终点
- 1.Number of days of use of Mechanical Ventilation
研究概览
简要总结
This is prospective,randomized, open label, comparative, clinical study to evaluate efficacy andsafety of Ulinastatin plus Standard-of-care compared to Standard-of-care (SOC) intreatment of acute respiratory distress syndrome (ARDS) in hospitalized COVID-19infection patient.
The patient will be randomized after informed consent to either group A or B. Group A will receive ulinastatin for 7 days with SOC and group B will receive on SOC. The patient will be observed closely for any respiratory dysfunction or other organ dysfunction on drug administration days and day 14 and discharge. The patient will be discharged at investigator’s discretion. The change from baseline values of respiratory functions, inflammatory markers, APACHE Score will be noted. The patient will be telephoned on day 28 to note any morbidity or mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Hospitalized adult aged >18-65 years inclusive 2.Confirmed COVID-19 infection (RT –PCR-test) 3.Symptoms of mild or moderate ARDS (Ref: MoHFW/ ICMR Revised guidelines on clinical management of COVID-19- 31Mar2020).
排除标准
- •1.Patients with history of HIV/HCV/HBV positive or immunocompromised or TB 2.Patients with significant co-morbidities at screening, as judged by the treating Investigator 3.Moribund state in which death is perceived to be imminent (≤48 hours) 4.Known hypersensitivity to any component of the investigational product 5.Pregnant or nursing (lactating) women.
- •6.Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
- •7.Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs/convalescent plasma (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).
- •8.Participation in any other clinical study.
结局指标
主要结局
1.Number of days of use of Mechanical Ventilation
时间窗: 1.Number of days of use of Mechanical Ventilation | 2.Change from baseline in PF ratio (PaO2/FiO2)
2.Change from baseline in PF ratio (PaO2/FiO2)
时间窗: 1.Number of days of use of Mechanical Ventilation | 2.Change from baseline in PF ratio (PaO2/FiO2)
次要结局
- Change in inflammatory markers(Change in Respiratory rate)