Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

Overview

The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.

Eligibility

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.