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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Viral Lung Infection and Acute Respiratory Failure

In brief

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.

Key facts

Study ID

NCT05624450

Run by

AstraZeneca

People needed

3527

Starts

2022-12-13

Expected to finish

2027-11-04

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Royal Oak, Michigan, United States (enrolling)
• Research Site — Winston-Salem, North Carolina, United States (enrolling)
• Research Site — Louisville, Kentucky, United States (enrolling)
• Research Site — Detroit, Michigan, United States (enrolling)
• Research Site — Kansas City, Missouri, United States (enrolling)
• Research Site — New York, New York, United States (enrolling)
• Research Site — Tucson, Arizona, United States (enrolling)
• Research Site — Evanston, Illinois, United States (enrolling)
• Research Site — Baton Rouge, Louisiana, United States (enrolling)
• Research Site — Annapolis, Maryland, United States (enrolling)
• Research Site — Saint Paul, Minnesota, United States (enrolling)
• Research Site — Washington D.C., District of Columbia, United States (enrolling)
• Research Site — Mobile, Alabama, United States (enrolling)
• Research Site — St Louis, Missouri, United States (enrolling)
• Research Site — Gainesville, Florida, United States (enrolling)
• Research Site — Jacksonville, Florida, United States (enrolling)
• Research Site — Lakeland, Florida, United States (enrolling)
• Research Site — Newport Beach, California, United States (enrolling)
• Research Site — Torrance, California, United States (enrolling)
• Research Site — Phoenix, Arizona, United States (enrolling)
• Research Site — Tampa, Florida, United States (enrolling)
• Research Site — Colorado Springs, Colorado, United States (enrolling)
• Research Site — Boise, Idaho, United States (enrolling)
• Research Site — Fresno, California, United States (enrolling)
• Research Site — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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