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Recruiting Phase 3

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

NCT05624450 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2022-12-13
Last updated
2026-10-02

Condition(s) studied

Viral Lung Infection and Acute Respiratory Failure

Investigational drug(s) / intervention(s)

Tozorakimab →Placebo

Tozorakimab: Single IV dose of tozorakimab on Day 1.

Placebo: Single IV dose of matching placebo on Day 1.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) — 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.

Trial sites (471)

FacilityCityRegionStatus
Research Site Birmingham Alabama Not Yet Recruiting
Research Site Mobile Alabama Recruiting
Research Site Phoenix Arizona Completed
Research Site Phoenix Arizona Withdrawn
Research Site Tucson Arizona Recruiting
Research Site Chula Vista California Withdrawn
Research Site Fresno California Recruiting
Research Site La Mesa California Withdrawn
Research Site Los Angeles California Withdrawn
Research Site Newport Beach California Recruiting
Research Site Torrance California Recruiting
Research Site Colorado Springs Colorado Recruiting
Research Site Denver Colorado Withdrawn
Research Site Washington D.C. District of Columbia Recruiting
Research Site Bradenton Florida Completed
Research Site Bradenton Florida Withdrawn
Research Site Gainesville Florida Recruiting
Research Site Jacksonville Florida Recruiting
Research Site Lakeland Florida Recruiting
Research Site Miami Florida Withdrawn
Research Site South Pasadena Florida Completed
Research Site St. Petersburg Florida Withdrawn
Research Site Tampa Florida Recruiting
Research Site Atlanta Georgia Withdrawn
Research Site Boise Idaho Recruiting
Research Site Chicago Illinois Completed
Research Site Elmhurst Illinois Withdrawn
Research Site Evanston Illinois Recruiting
Research Site Fort Wayne Indiana Withdrawn
Research Site Iowa City Iowa Withdrawn
Research Site Kansas City Kansas Withdrawn
Research Site Louisville Kentucky Recruiting
Research Site Baton Rouge Louisiana Recruiting
Research Site New Orleans Louisiana Withdrawn
Research Site Shreveport Louisiana Completed
Research Site Annapolis Maryland Recruiting
Research Site Silver Spring Maryland Completed
Research Site Springfield Massachusetts Completed
Research Site Worcester Massachusetts Completed
Research Site Detroit Michigan Recruiting

+ 431 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05624450 on ClinicalTrials.gov ↗ ← All trials in Italy