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

JRCT ID: jRCT2041220138

Registered date:08/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Viral Lung Infection
• Date of first enrollment: 10/05/2023
• Target sample size: 2902
• Countries of recruitment: Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Colombia,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hong Kong,Japan,Hungary,Japan,India,Japan,Israel,Japan,Italy,Japan,Malaysia,Japan,Mexico,Japan,Peru,Japan,Philippines,Japan,Poland,Japan,Rumania,Japan,Saudi Arabia,Japan,Slovakia,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Egypt,Japan,Thailand,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan,Vietnam,Japan
• Study type: Interventional

Intervention(s)

Drug: Tozorakimab/Placebo
Single IV dose of tozorakimab or matching placebo on Day 1.
Other Name: MEDI3506

Outcome(s)

Primary Outcome

Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) [ Time Frame: by Day 28 ]
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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT05624450