2023-507031-38-00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 (TILIA)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 828
- 试验地点
- 108
- 主要终点
- Proportion of participants who die or progress to IMV/ECMO by Day 28
研究概览
简要总结
To evaluate the effect of tozorakimab versus placebo as add on to SoC in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO by Day 28
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up
- 盲法
- Double (Monitor, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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 >
- •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.
- •The following malignancies: - Solid tumours with metastases (Stage IV). - Lymphoma/leukaemia not in complete remission. - Malignancies treated with chemotherapy and/or immunomodulatory drugs within the past 2 months.
结局指标
主要结局
Proportion of participants who die or progress to IMV/ECMO by Day 28
Proportion of participants who die or progress to IMV/ECMO by Day 28
次要结局
- 1. Proportion of participants who die by Day 60
- 2. Number of days alive and outside of ICU over 28 day period
- 3. Number of days alive and free of supplemental oxygen over 28 day period
- 4. Time to death or progression to IMV/ECMO
- 5. Proportion of participants who die or progress to IMV/ECMO by Day 60
- 6. Time to death (all cause)
- 7. Proportion of participants who die by Day 28
- 8. Number of days alive and free of IMV/ECMO over 28 day and 60 day period
- 9. Number of days alive and ventilator free over 28 day and 60 day period
- 10. Proportion of participants with ICU admission or death by Day 28 and Day 60
- 11. Proportion of participants alive and discharged by Day 28 and Day 60
- 12. Time to discharge
- 13. Time to being off supplemental oxygen
- 14. WHO CPS score rank-based comparison
- 15. Presence of anti-drug antibodies
- 16. Baseline serum biomarker levels relative to primary endpoint
研究者
AstraZeneca Clinical Study Information Center
Scientific
Astrazeneca AB
研究点 (108)
Loading locations...
相似试验
招募中
3 期
Study of durvalumab or placebo administered with radiation therapy for patients with early stage non-small cell lung cancer
Study of osimertinib administered after radiation therapy in patients with early stage non-small cell lung cancer harboring an EGFR mutation2024-512667-31-00AstraZeneca AB148
已完成
2 期
Phase II, Open-Label Study of preliminary efficacy of Sitravatinib in Combination with Tislelizumab in Patients with Metastatic Uveal Melanoma with liver metastases.2024-519451-29-00Grupo Espanol Multidisciplinar De Melanoma16
招募中
3 期
A Study to Evaluate how Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) whose Current Treatment is not Working Efficiently2024-519709-37-00Regeneron Pharmaceuticals Inc.8
招募中
3 期
A clinical study of zilovertamab vedotin in people with large B-cell lymphoma (MK-2140-010)2024-515566-13-00Merck Sharp & Dohme LLC265
尚未招募
2 期
Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, Single-arm, Multicenter Clinical StudyNCT07264010Nanfang Hospital, Southern Medical University87