Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 1
- 主要终点
- Number of Participants Who Are Classified 8 (Dead), 7 (Hospitalized, on Invasive Mechanical Ventilation or ECMO), or 6 (Hospitalized, on Non-invasive Ventilation or High Flow Oxygen Devices) on the NIAID Ordinal Scale
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of vadadustat for the prevention and treatment of acute respiratory distress syndrome (ARDS) in hospitalized patients with Coronavirus Disease 2019 (COVID-19).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Laboratory-confirmed diagnosis of COVID-19 by detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA by Reverse transcription polymerase chain reaction (RT-PCR) from any specimen respiratory
- •Admitted to the hospital within 36 hours
- •Oxygen saturation of hemoglobin by pulse oximetry at room air ≤94%
- •For patients admitted WITH respiratory symptoms, enrollment must occur within 36 hours of hospital admission. If the patient is admitted to the hospital with normal saturations, but develops respiratory symptoms DURING their hospital stay, enrollment may occur within 24 hours of desaturation to 94% or less on room air
- •Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure
排除标准
- •Hypersensitivity to vadadustat or any of its excipients
- •Placed on mechanical ventilation before randomization
- •Hemoglobin above the gender-specific upper limit of normal (ULN) at randomization: 16 g/dL for females and 18 g/dL for males
- •Patients who have erythrocytosis or polycythemia vera
- •Patient taking Probenecid, lopinavir or ritonavir
- •Women who are pregnant or breastfeeding, or positive pregnancy test before randomization
- •Patients not on maintenance dialysis with eGFC < 31 ml/min
- •Patients who have received a solid organ transplant, heart, kidney, liver or lung
- •Patients who are prisoners
- •Patients who are currently Do Not Resuscitate (DNR) or Do Not Intubate (DNI)
- •Patients with modified Rankin scale of 3 or greater
- •Patient who are currently enrolled in any other interventional clinical trial
研究组 & 干预措施
vadadustat
干预措施: vadadustat (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Number of Participants Who Are Classified 8 (Dead), 7 (Hospitalized, on Invasive Mechanical Ventilation or ECMO), or 6 (Hospitalized, on Non-invasive Ventilation or High Flow Oxygen Devices) on the NIAID Ordinal Scale
时间窗: day 14
National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS): 8 - Death 7 - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 6 - Hospitalized, on non-invasive ventilation or high flow oxygen devices 5 - Hospitalized, requiring supplemental oxygen 4 - Hospitalized, not requiring supplemental oxygen - requiring ongoing care (COVID-19 related or otherwise) 3 - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 2 - Not hospitalized, limitation on activities and/or requiring home oxygen 1 - Not hospitalized, no limitations on activities
次要结局
- Number of Participants With a Total Score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) Scale(day 14)
研究者
Bentley J. Bobrow
Professor
The University of Texas Health Science Center, Houston