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

A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen - TILIA

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041220138

Enrollment

135

Registered

2023-02-08

Start date

2023-05-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Viral Lung Infection

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Peru, Philippines, Poland, Rumania, Saudi Arabia, South Africa, Spain, Sweden, Taiwan

Contacts

Public ContactYuji Ageishi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026