Abatacept for Patients With COVID-19 and Respiratory Distress
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Mechanical ventilation-free survival
研究概览
简要总结
This is a single-arm open label trial for hospitalized patients with COVID-19 (Coronavirus). The primary endpoint of the study is to assess the requirement for mechanical ventilation in patients who are admitted to the hospital with COVID-19 infection and a Pulse Oxygen Level </= 93% on room air. The primary endpoint analysis will be performed using all enrolled patients.
详细描述
Patients with COVID-19 who are admitted with respiratory distress will be considered for enrollment on this study. Patients will be screened and then if they meet eligibility criteria will be enrolled. Abatacept will be administered on Day 1 at a dose of 10 mg/kg. Patients will then be followed closely through 90 days post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Must be at least 18 years old.
- •Confirmed SARS-CoV-2 infection, confirmed by polymerase chain reaction (PCR) </=4 days prior to enrollment
- •Evidence of respiratory distress including SpO2 </=93% on room air.
- •Radiographic evidence of pulmonary infiltrates.
- •Ability to understand and the willingness to provide informed consent.
排除标准
- •Patients already intubated/mechanically ventilated at screening will not be eligible.
- •Patients with uncontrolled severe bacterial or fungal infections at the time of enrollment.
- •Patients with previously diagnosed autoimmune disorders or who were on immunosuppressive medications prior to developing COVID-19 are not eligible
- •Pregnant or breastfeeding
研究组 & 干预措施
AbataceptTreatment Arm
Enrolled patients who will receive treatment with abatacept
干预措施: Abatacept (Drug)
结局指标
主要结局
Mechanical ventilation-free survival
时间窗: 30 days
Cumulative incidence of mechanical ventilation-free survival at 30 days after initiation of abatacept
次要结局
- Days until pulse oxygen is > 93% on room air(30 days)
- Duration of days on a ventilator(30 days)
- Viral load(28 days)
- Days until supplemental oxygen is no longer required(30 days)
- Duration of fever >= 38°C(30 days)
- Overall survival(90 days)
- Infusion reactions(14 days)
- Secondary infections(90 days)
- Radiographic Improvement(14 days)
- Change in Clinical Status, based on 7-point ordinal scale(14 days)