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Evaluating Tozorakimab for Patients with Viral Lung Infections Needing 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

Phase 3 Interventional AstraZeneca · NCT05624450

This study is testing if a new drug called tozorakimab can help adults with viral lung infections who need extra oxygen feel better and avoid serious complications.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2870 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionstozorakimab
Locations451 sites (Mobile, Alabama and 450 other locations)
Trial IDNCT05624450 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of tozorakimab, an investigational drug, as an additional treatment for adults hospitalized with viral lung infections who require supplemental oxygen. The study will compare the effects of tozorakimab against a placebo to determine its impact on preventing death or the need for invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Participants must be experiencing hypoxaemia and meet specific criteria related to their respiratory condition. The trial is designed to provide insights into the potential benefits of tozorakimab in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are hospitalized with viral lung infections and require supplemental oxygen due to hypoxaemia.

Not a fit: Patients with known fungal or parasitic lung infections, or those whose hypoxaemia is caused by non-infective lung injury, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce mortality and the need for invasive respiratory support in patients with severe viral lung infections.

How similar studies have performed: Other studies have explored treatments for viral lung infections, but the specific use of tozorakimab in this context is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Mobile, Alabama and 450 other locations

+401 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Viral Lung Infection and Acute Respiratory FailureAcute Respiratory FailureAcute Respiratory Distress SyndromeViral lung infectionTozorakimabSupplemental OxygenIL-33COVID-19
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.