NCT04629703已完成3 期
Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 45
- 主要终点
- Number of days on oxygen from randomization on Day 1 to Day 29
研究概览
简要总结
The study is a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.
详细描述
The primary objective of this study is:
To evaluate the efficacy of fostamatinib when used in combination with standard of care (SOC) in subjects hospitalized with COVID- 19 and requiring oxygen supplementation, as measured by days on oxygen.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age at screening.
- •The subject or a legally authorized representative has provided written informed consent.
- •Hospitalized COVID-19 subjects without respiratory failure who are either not receiving any oxygen therapy or are receiving supplemental oxygen via mask or nasal prongs.
- •Male or non-pregnant, non-lactating female subjects with SARS-CoV-2 infection documented by a hospital approved diagnostic test (eg, a Food and Drug Administration authorized test in the US) within 7 days prior to randomization.
排除标准
- •Pregnant or lactating female of childbearing potential.
- •Use of extracorporeal membrane oxygenation (ECMO).
- •Uncontrolled hypertension (systolic blood pressure [BP] ≥160 mmHg and/or diastolic BP ≥100 mmHg), unstable angina, congestive heart failure of New York Heart Association classification III or IV, serious cardiac arrhythmia requiring treatment at screening.
- •History of myocardial infarction within 1 month prior to screening.
研究组 & 干预措施
Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
Active Comparator
Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
干预措施: Fostamatinib (Drug)
Placebo (twice daily for 14 days) + Standard of Care
Placebo Comparator
Placebo (twice daily for 14 days) + Standard of Care
干预措施: Placebo (Drug)
结局指标
主要结局
Number of days on oxygen from randomization on Day 1 to Day 29
时间窗: 29 days
Number of days on oxygen from randomization on Day 1 to Day 29
次要结局
- Proportion of subjects alive by Day 60 and oxygen free on Day 29(60 days)
- Mean change from baseline over time in clinical status score using the 8-point ordinal scale, to the average from Day 5 through Day 15.(10 days)
- All-cause mortality by Day 29.(29 days)
- Number of days in the ICU from randomization on Day 1 to Day 29(29 days)
- Time to first sustained hospital discharge by Day 29. (A discharge is defined as sustained when no readmission occurs by Day 29 after the discharge).(29 days)
- All-cause mortality by Day 60(60 days)
- Proportion of subjects alive by Day 29 and oxygen free on Day 29.(29 days)
研究者
研究点 (45)
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