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

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Viral Lung Infection and Acute Respiratory Failure

Treatments: Drug: Tozorakimab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05624450

D9185C00001

2023-507031-38-00 (Registry Identifier)

2022-003107-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 2,870 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

• Patient remains hypoxaemic at randomisation requiring treatment with supplemental oxygen.

Exclusion criteria

• Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or evidence of septic shock. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,870 participants in 2 patient groups, including a placebo group

Tozorakimab

Experimental group

Description:

Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab.

Treatment:

Drug: Tozorakimab

Placebo

Placebo Comparator group

Description:

Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1435) will receive matching placebo.

Treatment:

Drug: Placebo