A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With Acute Respiratory Distress Syndrome Associated With COVID-19 (Trial H1: Aviptadil)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 471
- 试验地点
- 40
- 主要终点
- Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90
研究概览
简要总结
This study looks at the safety and effectiveness of Aviptadil in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with Aviptadil plus current standard of care (SOC), or with placebo plus current SOC.
详细描述
This is a treatment trial of the ACTIV-3b/TESICO master protocol (NCT04843761) to evaluate the safety and efficacy of Aviptadil at improving outcomes for patients with acute respiratory failure related to COVID-19.
This protocol will be adaptive, randomized, blinded and initially placebo-controlled. Participants will receive standard of care (SOC) treatment as part of the protocol.
This protocol will be conducted in up to several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.
The protocol is for a Phase 3 study.
Participants will be followed for 90 days following randomization for the primary endpoint and most secondary endpoints. Selected secondary endpoints will be measured at 180 days.
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)
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
- •Refer to the master protocol (NCT04843761)
排除标准
- •Refer to the master protocol (NCT04843761)
- •Additional Exclusion Criteria:
- •Refractory hypotension
- •Severe diarrhea
- •Current C. difficile infection
- •Pregnancy or current breast-feeding
- •End-stage liver disease
研究组 & 干预措施
Aviptadil + SOC
干预措施: Aviptadil (Biological)
Aviptadil + SOC
干预措施: Corticosteroid (Drug)
Placebo + SOC
干预措施: Aviptadil Placebo (Biological)
Placebo + SOC
干预措施: Corticosteroid (Drug)
结局指标
主要结局
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90
时间窗: Status on Day 90
The primary outcome was a 6-category ordinal outcome defining the participant's status at Day 90: (1) at home (defined as the type of residence before hospitalization) and off oxygen (recovered) for at least 77 days, (2) at home and off oxygen for 49-76 days, (3) at home and off oxygen for 1-48 days, (4) not hospitalized but either on supplemental oxygen or not at home, (5) hospitalized or in hospice care, or (6) dead.
次要结局
- Number of Participants Who Died Through Day 90(Through Day 90)
- Number of Participants With a Safety Outcome Through Day 5(Through Day 5)
- Number of Participants With a Safety Outcome Through Day 28(Through Day 28)
- Number of Participants Who Died Through Day 180(Through Day 180)