A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection
试验速览
- 阶段
- 2 期
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Percent of subjects who have returned to room air
研究概览
简要总结
This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.
详细描述
Cohort 1: It is designed as a two stage, multi-center, randomized, double-blind, two parallel doses, placebo-controlled study that will investigate the efficacy of DAS181 for the treatment of serious IFV in hospitalized patients who suffered from acute hypoxemia requiring supplemental oxygen therapy.
Cohort 2: It is designed as an open-label study that will investigate the efficacy of DAS181 for the treatment of patients with sever IFV but not eligible for Cohort 1 and non-IFV SAD viral infection, e.g. parainfluenza virus, human metapneumovirus, enterovirus and all strains of β-coronaviruses (including but not limited to SARS-CoV-2), with hypoxemia requiring supplemental oxygen therapy.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Stage 2, Ansun will know the dosage.
入排标准
- 年龄范围
- 18 Years 至 —（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
DAS181 SD group Cohort 1, Stage 1
DAS181 SD group 4.5mg/day for 7 or 10 days
干预措施: DAS181 (Drug)
DAS181 HD group Cohort 1, Stage 1
DAS181 HD group 9mg/day for 7 or 10 days.
干预措施: DAS181 (Drug)
Placebo, Cohort 1, Stage 1
Placebo 0mg/day for 7 or 10 days
干预措施: Placebo (Drug)
DAS181 group, Cohort 1, Stage 2
DAS181 4.5mg/day or 9mg/day. Dosage will be determined after completion of stage 1.
干预措施: DAS181 (Drug)
Placebo, Cohort 1, Stage 2
Placebo 0mg/day for 7 or 10 days
干预措施: Placebo (Drug)
DAS181 group, Cohort 2, Stage1 and 2
DAS181 4.5mg/day or 9mg/day for 7 or 10 days
干预措施: DAS181 (Drug)
结局指标
主要结局
Percent of subjects who have returned to room air
时间窗: 7 days
Percent of subjects who have returned to room air
Percent change of subjects return to baseline oxygen requirement
时间窗: 7 days
Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1
次要结局
未报告次要终点