Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of the Efficacy and Safety of Intravenous Pamrevlumab, a Monoclonal Antibody Against Connective Tissue Growth Factor (CTGF), in Hospitalized Patients With Acute COVID-19 Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- FibroGen
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28
研究概览
简要总结
This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab when compared with placebo in participants who are hospitalized with acute COVID-19 disease.
详细描述
This is a randomized, double-blind, placebo-controlled, phase 2, proof-of-concept study to evaluate the efficacy and safety of IV pamrevlumab, a monoclonal antibody, against connective-tissue growth factor (CTGF), in participants hospitalized with acute COVID-19 disease.
All concomitant medications, including approved and non-approved treatments for COVID-19 (such as, hydroxychloroquine or interleukin 6 [IL-6] inhibitors), as well as supplemental oxygenation needs, will be collected and recorded. In addition, the following will be collected and recorded: documentation of Severe Acute Respiratory Syndrome coronavirus (SARS-Cov-2) infection, documentation of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (such as a Do Not Resuscitate/Do Not Intubate [DNR/DNI] order or a resource limitation).
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed SARS-CoV-2 infection
- •Respiratory compromise requiring hospitalization for COVID-19 disease as evidenced by at least one (or more) of the following criteria:
- •Interstitial pneumonia on chest x-ray or high-resolution computed tomography (findings of consolidation or ground glass opacities), OR
- •Peripheral capillary oxygen saturation < 94% on room air, OR
- •Requiring non-invasive supplemental oxygen (such as, nasal cannula, face mask) to maintain SpO2
- •Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) use at time of randomization
- •Not participating in another clinical trial for the treatment of COVID-19 disease through Day 28
排除标准
- •Female participants who are pregnant or nursing
- •Participation in a clinical trial with another investigational drug for COVID-19 disease
- •Anticipated discharge from the hospital or transfer to another hospital or long-term care facility which is not a study site within 72 hours of randomization
- •History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
研究组 & 干预措施
Pamrevlumab
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
干预措施: Pamrevlumab (Drug)
Placebo
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28
时间窗: Day 28
次要结局
- Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14(Day 14)
- Number of Participants With All-cause Mortality(up to Day 28)
- Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO)(up to Day 28)
- Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28(Day 28)
- Days on Mechanical Ventilation and/or ECMO(up to Day 28)
- Time to Mechanical Ventilation/ECMO or All-cause Mortality(up to Day 28)
- Change in (Non-invasive) Oxygen Supplementation Requirements(up to Day 28)
- Time to Recovery as Based on a Modified 8-Point Ordinal Scale(Day 28)
- Changes in Pressure of Arterial Oxygen to Fractional Inspired Oxygen Concentration (PaO2/FiO2) Ratio, Both as Categorical and Continuous Variables(up to Day 28)
- Time to Death From Any Cause(up to Day 28)
- Change in Resting Peripheral Oxygen Saturation (SpO2) Adjusted by FiO2(up to Day 28)