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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Tozorakimab (drug)
- Placebo (drug)
Sponsor: AstraZeneca · Participants: 3,527 · Started: Dec 13, 2022
Contact the study team
- AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479
Official record on ClinicalTrials.gov — NCT05624450
Locations in the U.S.
Conditions
- Respiratory Distress Syndrome
- Post-COVID Conditions (Long COVID)
- COVID-19 and Coronavirus Infections
- Viral Infections
- Respiratory Tract Infections
- Lung Diseases
- Flu
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.