A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 10
- 主要终点
- Time to Breathing Room Air
研究概览
简要总结
The primary objective of this study was to evaluate if the addition of zanubrutinib to supportive care increases the respiratory failure-free survival rate at Day 28 in participants hospitalized for Corona Virus Disease 2019 (COVID-19) and pulmonary distress not receiving mechanical ventilation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization for COVID-19 infection
- •Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR)
- •Participant requires supplemental oxygen for pulmonary distress related to COVID-19 infection, and has been on supplemental oxygen for no more than 96 hours from time of screening
排除标准
- •Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
- •On a Bruton's tyrosine kinase (BTK) inhibitor
- •Planned or concurrent use of a host modifiers/immune-based therapies or anti-CD20 monoclonal antibody treatment
- •Participants with prior of current hematologic malignancy or solid tumor malignancy with treatment within 6 months prior to study entry
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Zanubrutinib + Supportive Care
Participants received zanubrutinib plus supportive care
干预措施: Zanubrutinib (Drug)
Zanubrutinib + Supportive Care
Participants received zanubrutinib plus supportive care
干预措施: Supportive Care (Drug)
Placebo + Supportive Care
Participants received placebo plus supportive care alone
干预措施: Supportive Care (Drug)
Placebo + Supportive Care
Participants received placebo plus supportive care alone
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Breathing Room Air
时间窗: Up to 7 months
Time to return to breathing room air is defined as the time from randomization date to the earliest time where the participant is stable on room air without supplemental oxygen. Total follow-up time in days is the total time of all participants from the randomization date to the first event date or Day 28 if there is no event. The rate was calculated as total number of events in which a participant returned to breathing room air on or before Day 28 divided by the total follow-up time in days.
Number of Participants With Respiratory Failure-free Survival
时间窗: Up to Day 28
Number of participants with respiratory failure-free survival, defined as not having died or gone into respiratory failure on or before Day 28
次要结局
- Number of Participants With All-cause Mortality(Up to Day 28)
- Duration of Mechanical Ventilation(Up to Day 28)
- Number of Participants Discharged Alive From the ICU(Up to Day 28)
- Number of Participants Experiencing Respiratory Failure or Death(Up to Day 28)
- Number of Participants With Adverse Events(Up to 7 months)
- Number of Participants Discharged Alive(Up to Day 28)
- Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale(Up to Day 28)
- Duration of Hospitalization(Up to Day 28)
- PaO2:FiO2 Ratio(Baseline, Day 7, Day 14, Day 21 and Day 28)