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 sites0 target enrollmentMarch 11, 2024

Overview

No summary available.

Registry

who.int

Start Date

March 11, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•1\.Adult participants \= 18 years old at the time of signing the ICF.
•Type of Participant and Disease Characteristics:
•2\.Patients hospitalised with viral lung infection. Note: Suspected viral aetiology is acceptable to meet this criterion.
•3\.Hypoxaemia requiring treatment with supplemental O2\. Hypoxaemia is defined as:
•?SpO2 \= 90% OR
•?SpO2 \= 92% AND one or both of the following:
•oRadiographic infiltrates by Chest X\-ray/CT scan compatible with viral lung infection per investigator judgement.
•oUse of accessory muscles of respiration or respiratory rate \> 22/minute.
•Note: Patients receiving oxygen \> 6 L/min or non\-invasive ventilation will be considered
•to have met this inclusion criterion regardless of SpO2 levels. A documented pre\-hospital

•Medical Conditions:
•1Known 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.
•2Hypoxaemia caused primarily by extrapulmonary insult (eg, multiorgan failure, shock, or sepsis) or by lung injury of noninfective aetiology (eg, trauma, chemical injury, etc).
•3Ongoing IMV/ECMO at randomisation.
•4Any comorbid condition that, in the opinion of the investigator, is likely to result in death within 3 months from randomisation.
•5Anticipated recovery and discharge from the hospital within 24 hours of randomisation.
•6Active tuberculosis defined as disease requiring current treatment.
•7Known unstable cardiovascular disease (eg, unstable chronic heart failure NYHA III\-IV, recent myocardial infarction or stroke within 3 months, uncontrolled ventricular arrhythmia, or cardiogenic pulmonary oedema which is driving the severity of the hypoxaemia, that in the investigator’s judgement may put the participant at risk or negatively affect the outcome of the study).
•8Known absolute neutrophil count \= 1\.0 x 109/L.
•9Known untreated HIV. Known history of active hepatitis B or C (treated and controlled hepatitis and HIV are allowed).