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

Ageishi Yuji0 个研究点目标入组 2,902 人开始时间: 2023年2月8日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•Adult participants 18 years old or more at the time of signing the informed consent form.
•- Patients hospitalised with viral lung infection.
•- Hypoxaemia requiring treatment with supplemental O2. Hypoxaemia is defined as:
•- SpO2 90% or less OR
•- SpO2 92% or less AND one or both of the following:
•o Radiographic infiltrates by Chest X-ray/CT scan compatible with viral lung infection per investigator judgement.
•o Use of accessory muscles of respiration or respiratory rate over 22/minute.

•- 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.
•- Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology.
•- Ongoing IMV/ECMO at randomisation.

发起方

Ageishi Yuji