Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA)
Viral Lung Infection and Acute Respiratory Failure
About this trial
This is an interventional treatment trial for Viral Lung Infection and Acute Respiratory Failure focused on measuring Acute Respiratory Failure, Acute Respiratory Distress Syndrome, Viral lung infection, Tozorakimab, Supplemental Oxygen, IL-33, COVID-19, SARS-CoV-2, Coronavirus Infections, Virus Diseases, SARS Coronavirus, MEDI3506, Respiratory Tract Infections, Infections, Lung Diseases, Influenza
Eligibility Criteria
Inclusion Criteria: 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 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 (respiratory rate) > 22. Exclusion Criteria: 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.
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Tozorakimab
Placebo
Approximately 2902 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1451) will receive a single dose of tozorakimab.
Approximately 2902 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1451) will receive matching placebo.