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

Phase 3

Recruiting

• Conditions: Viral Lung Infection

• Registration Number: JPRN-jRCT2041220138
• Lead Sponsor: Ageishi Yuji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-08
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2902

Inclusion Criteria

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) [ Time Frame: by Day 28 ]<br>To evaluate the effect of tozorakimab versus placebo as an add on to Standard of Care (SoC) in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO by Day 28.