NCT05624450招募中3 期
A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 3,527
- 试验地点
- 482
- 主要终点
- Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
研究概览
简要总结
The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.
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
- Triple (Participant, Care Provider, 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
- •Adult participants ≥ 18 years old at the time of signing the informed consent form.
- •Patients hospitalised with viral lung infection.
- •Hypoxaemia requiring treatment with supplemental O
- •Hypoxaemia is defined as:
- •SpO2 ≤ 90% OR
- •SpO2 ≤ 92% AND one or both of the following:
- •Radiographic infiltrates by CXR/CT compatible with viral lung infection per investigator judgement.
- •Use of accessory muscles of respiration or RR (respiratory rate) >
- •- Patient remains hypoxaemic at randomisation requiring treatment with supplemental oxygen.
排除标准
- •Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or evidence of septic shock. Bacterial co-infection is allowed, unless, in the opinion of the investigator, bacterial infection defines the severity of the participant's condition.
- •Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology.
- •Ongoing IMV/ECMO at randomisation.
研究组 & 干预措施
Tozorakimab
Experimental
Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab.
干预措施: Tozorakimab (Drug)
Placebo
Placebo Comparator
Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1435) will receive matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
时间窗: by Day 28
To evaluate the effect of tozorakimab versus placebo as an add on to Standard of Care (SoC) in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO.
次要结局
- Proportion of participants who die(by Day 28)
- Number of days alive and outside of Intensive Care Unit (ICU)(over 28 day period)
- Number of days alive and free of supplemental oxygen(over 28 day period)
- Time to death or progression to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)(over 28 day and 60 day period)
- Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)(by Day 60)
- Time to death (all cause)(over 28 day and 60 day period)
- Number of days alive and free of Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)(over 28 day and 60 day period)
- Number of days alive and ventilator free(over 28 day and 60 day period)
- Proportion of participants with Intensive Care Unit (ICU) admission or death(by Day 60)
- Proportion of participants alive and discharged(by Day 60)
- Time to discharge(over 28 day and 60 day period)
- Time to being off supplemental oxygen(over 28 day and 60 day period)
- World Health Organization (WHO) 10-category ordinal Clinical Progression Scale(by Day 60)
- Presence of anti-drug antibodies(over 60 day period)
- Baseline serum interleukin-33/soluble Suppression of Tumorgenicity 2 (IL-33/sST2) complex levels relative to primary endpoint(Day 1)
- Proportion of participants who die(by Day 60)
- Proportion of participants with Intensive Care Unit (ICU) admission or death(by Day 28)
- Proportion of participants alive and discharged(by Day 28)
研究者
研究点 (482)
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