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Tozorakimab for Viral Lung Infection Requiring Oxygen

This study is testing a drug called tozorakimab for people hospitalized with a viral lung infection who need extra oxygen. Researchers want to see if tozorakimab, given as a single IV dose, can help prevent death or the need for more advanced breathing support like a ventilator (Invasive Mechanical Ventilation or IMV) or a heart-lung machine (Extracorporeal Membrane Oxygenation or ECMO). You might be able to join if you are an adult (18 or older) with a viral lung infection and low oxygen levels (hypoxemia) requiring supplemental oxygen. The study will compare tozorakimab to a placebo (an inactive substance). The main goal is to see how many people die or need IMV/ECMO by Day 28. The study aims to enroll 3527 participants, but its current recruitment status is unclear.

Study design
This interventional study is designed to compare tozorakimab to a placebo in about 3527 participants.
What's involved
Participants will receive a single IV dose of either tozorakimab or placebo on Day 1.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to see if they die or need advanced breathing support by Day 28.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05624450

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~3,527 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:TozorakimabPlacebo

At a glance

Recruiting sites
245 of 468 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
Measured over by Day 28

Conditions

Viral Lung Infection and Acute Respiratory Failure

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Acute Respiratory Distress SyndromeAcute Respiratory FailureCOVID-19 InfectionInfluenzaViral Infection

Where it's being run

468 sites across 75 states
Japan46
China42
Brazil20
India17
United Kingdom15
France13
Germany12
Malaysia12

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • 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.