NCT04369469终止3 期
A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared With Best Supportive Care in Patients With COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 202
- 试验地点
- 75
- 主要终点
- Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29
研究概览
简要总结
This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Participants were randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the participants) or BSC alone (1/3 of the participants). BSC consisted of medical treatment and/or medical interventions per routine hospital practice.
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
- 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
- •Males or female participants ≥ 18 years of age and ≥ 40 kilograms at the time of providing informed consent.
- •Confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 infection (for example, via polymerase chain reaction and/or antibody test) presenting as severe COVID-19 requiring hospitalization.
- •Severe pneumonia, acute lung injury, or acute respiratory distress syndrome confirmed by computed tomography or X-ray at Screening or within the 3 days prior to Screening, as part of the participant's routine clinical care.
- •Respiratory distress requiring mechanical ventilation, which can be either invasive (requiring endotracheal intubation) or noninvasive (with continuous positive airway pressure or bilevel positive airway pressure).
- •Female participants of childbearing potential and male participants with female partners of childbearing potential must follow protocol specified contraception guidance for avoiding pregnancy for 8 months after treatment with the study drug.
排除标准
- •Participant was not expected to survive for more than 24 hours.
- •Participant was on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening.
- •Severe pre-existing cardiac disease (that is, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias).
- •Participant had an unresolved Neisseria meningitidis infection.
- •Used the following medications and therapies:
- •Current treatment with a complement inhibitor or
- •Intravenous immunoglobulin within 4 weeks prior to randomization on Day 1
- •Treatment with investigational therapy in a clinical study within 30 days before randomization, or within 5 half-lives of that investigational therapy, whichever was greater. Exceptions:
- •Investigational therapies were allowed if received as part of BSC through an expanded access protocol or emergency approval for the treatment of COVID-
- •Investigational antiviral therapies (such as remdesivir) were allowed even if received as part of a clinical study.
- •Female participants who were breastfeeding or who have a positive pregnancy test result at Screening.
- •History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins.
- •Participant who was not currently vaccinated against Neisseria meningitidis, unless the participant agrees to receive prophylactic treatment with appropriate antibiotics for at least 8 months after the last infusion of study drug or until at least 2 weeks after the participant receives vaccination against Neisseria meningitidis.
结局指标
主要结局
Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29
时间窗: Day 29
Survival (based on all-cause mortality) in Participants in the ITT Population at Day 29 was analyzed. The result for the survival was estimated survival combined over all imputations.
次要结局
- Number Of Days Free Of Mechanical Ventilation At Day 29(Day 29)
- Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29(Baseline, Day 29)
- Number of Days the Participants Were Alive and Not in the Hospital(Day 1 through Day 29)
- Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90(Up to Day 60 and Up to Day 90)
- Number of Days the Participants Were Alive and Not in ICU(Day 1 through Day 29)
- Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29(Baseline, Day 29)
- Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29(Day 1 and Day 29)
- Change From Baseline In Terminal Complement Complex C5b-9 At Day 29(Baseline, Day 29)
- Change From Baseline In Serum Free Complement Component 5 Concentrations At Day 29(Baseline, Day 29)
研究者
研究点 (75)
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