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).

AstraZeneca AB0 个研究点目标入组 2,902 人开始时间: 2022年12月13日最近更新: 2024年2月26日

适应症

试验速览

暂无简介。

•1. Adult participants = 18 years old at the time of signing the informed consent form.
•2. Patients hospitalised with viral lung infection.
•3. Hypoxaemia requiring treatment with supplemental O2
•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 > 22.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1451
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1451

•1. Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or pulmonary sepsis. Bacterial co-infection is allowed, unless, in the opinion of the investigator, bacterial infection defines the severity of the participant’s condition.
•2. Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology.
•3. Ongoing or impending IMV/ECMO at randomisation.
•4. 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.

发起方