NCT04472494终止2 期
Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
Bristol-Myers Squibb20 个研究点 分布在 2 个国家目标入组 61 人开始时间: 2020年10月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 61
- 试验地点
- 20
- 主要终点
- Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept administered to hospitalized COVID-19 participants with respiratory compromise.
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
- Double (Participant, 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
- •A confirmed virological diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (by reverse-transcription polymerase chain reaction (RT-PCR)).
- •Hospitalized (or in the Emergency Department awaiting a bed after hospitalization)
- •Respiratory compromise as defined by requirement of oxygen supplementation to maintain oxygen saturation ≥ 93% but not requiring mechanical ventilation
- •Abnormal chest X-ray consistent with COVID-19 and not indicating other serious medical condition that would serve as an exclusionary criteria
- •Women and men must agree to follow specific methods of contraception, if applicable
排除标准
- •Women who are breastfeeding
- •Recent acute infection defined as:
- •i) Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics (not COVID-19 related) ii) Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy
- •History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis)
- •Prior exposure to BMS-188667 (abatacept)
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28
时间窗: From first dose to 28 days post first dose
The percentage of participants on invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal tube (or tracheostomy) or death prior to or on day 28.
次要结局
- Percentage of Participants Who Died(From first dose to 28 days post first dose)
- Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3(Day 28±3)
- Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28(Baseline and on Day 28)
- Percentage of Participants Returned to Room Air on Day 28(Day 28)
- Percentage of Participants Alive and Discharged From the Hospital by Day 28(From day 1 up to day 28)
- Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class(From first dose to 60 days post first dose)
- Percentage of Participants With Serious Adverse Events(From first dose to 60 days post first dose)
研究者
研究点 (20)
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