Crizanlizumab for Treating COVID-19 Vasculopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Soluble P-selectin Level
研究概览
简要总结
The purpose of this trial is to test the efficacy and safety of crizanlizumab in patients hospitalized with COVID-19.
详细描述
Infection with severe acute respiratory syndrome (SARS) coronavirus 2 (CoV-2) causes coronavirus disease 2019 (COVID-19). The clinical course of COVID-19 is variable, and some patients develop severe pneumonia, multi-organ failure, and shock.
Severe COVID-19 is characterized by a hyper-inflammatory and hyper-thrombotic state. We propose that this state is caused by viral injury of the vascular endothelium, leading to endothelial release of von Willebrand Factor (VWF) and P-selectin, which in turn drive thrombosis and vascular inflammation.
Crizanlizumab is a monoclonal antibody that targets P-selectin. Crizanlizumab can decrease inflammation by binding to P-selectin, blocking leucocyte and platelet adherence to the vessel wall.
We now plan to test the safety and efficacy of crizanlizumab in decreasing biomarkers of inflammation and thrombosis in a placebo-controlled, double-blind randomized clinical trial
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
- •Willing to provide written informed consent
- •Willing to comply with all study procedures and be available for the duration of the study
- •Male or female ≥ 18 years of age
- •SARS-CoV-2 infection (COVID-19) within the past 10 d documented by laboratory test (nucleic acid test (NAT) or reverse transcriptase-polymerase chain reaction (RT-PCR))
- •Currently hospitalized
- •Symptoms of acute respiratory infection (at least one of the following: cough, fever > 37.5°C, dyspnea, sore throat, anosmia),
- •Radiographic evidence of pulmonary infiltrates
- •Requiring supplemental oxygen or the peripheral capillary oxygenation saturation (SpO2) < 94% on room air at screening
- •Elevated D-Dimer > 0.49 mg/L
- •Negative pregnancy test for females of childbearing potential
排除标准
- •Use of home oxygen at baseline
- •Current use of mechanical ventilation
- •Inability to provide consent
- •Do not intubate status
- •Prisoner or incarcerated
- •Pregnancy or Breast Feeding
- •Participation in other interventional therapy trials for COVID-
- •International normalized ratio (INR) > 3 or activated partial thromboplastin time (aPTT) > 60
研究组 & 干预措施
Crizanlizumab
Crizanlizumab is a monoclonal antibody targeting P-selectin. Crizanlizumab 5.0 mg/kg in 100 ml IV once.
干预措施: Crizanlizumab (Drug)
Placebo Saline
0.9% saline 100 ml IV once.
干预措施: 0.9% saline (Other)
结局指标
主要结局
Soluble P-selectin Level
时间窗: Day 3 after randomization or day of hospital discharge, whichever is earlier
Level of soluble P-selectin in ng/mL.
次要结局
- D-dimer Level(Day 14 after randomization)
- Time to Hospital Discharge(Up to 30 days after randomization)
- Safety of Crizanlizumab as Assessed by Adverse Events(Up to day 14 after randomization)
- Soluble P-selectin Level(Day 14 after randomization)
- VWF Level(Day 14 after randomization)
- CRP Level(Day 14 after randomization)
- Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials(Days 3, 7 and 14 after randomization)