Recruiting
Phase 3

Tozorakimab

Sponsor:

AstraZeneca

Code:

NCT05624450

Conditions

Viral Lung Infection and Acute Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tozorakimab

Placebo

Study Details

Brief 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.

Conditions

Viral Lung Infection and Acute Respiratory Failure

Study ID

NCT05624450

Start date

Dec 13, 2022

Status verified date

Aug, 2026

Completion date

Nov 4, 2027

Anticipated

Primary completion date

Nov 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

3527 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tozorakimab

Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab.

placebo comparator: Placebo

Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1435) will receive matching placebo.

Interventions

Tozorakimab

Single IV dose of tozorakimab on Day 1.

Placebo

Single IV dose of matching placebo on Day 1.

Primary outcome measure

  • Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) [ Time Frame: by Day 28 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Mobile, Alabama, United States, 36608

Research Site

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Tucson, Arizona, United States, 85719

Research Site

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Fresno, California, United States, 93701

Research Site

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Newport Beach, California, United States, 92663

Research Site

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Torrance, California, United States, 90505

Research Site

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Colorado Springs, Colorado, United States, 80909

Research Site

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Washington D.C., District of Columbia, United States, 20037

Research Site

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Gainesville, Florida, United States, 32611

Research Site

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Jacksonville, Florida, United States, 32224

Research Site

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Lakeland, Florida, United States, 33805

Research Site

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Tampa, Florida, United States, 33617

Research Site

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Boise, Idaho, United States, 83702

Research Site

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Evanston, Illinois, United States, 60201

Research Site

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Louisville, Kentucky, United States, 40202

Research Site

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Baton Rouge, Louisiana, United States, 70808

Research Site

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Annapolis, Maryland, United States, 21401

Research Site

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Detroit, Michigan, United States, 48202

Research Site

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Royal Oak, Michigan, United States, 48073

Research Site

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Saint Paul, Minnesota, United States, 55101

Research Site

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Kansas City, Missouri, United States, 64108

Research Site

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St Louis, Missouri, United States, 63110

Research Site

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New York, New York, United States, 10039

Research Site

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Winston-Salem, North Carolina, United States, 27157

Research Site

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Columbus, Ohio, United States, 43210

Research Site

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Oklahoma City, Oklahoma, United States, 73104

Research Site

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Greenville, South Carolina, United States, 29605

Research Site

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Dallas, Texas, United States, 75204

Research Site

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El Paso, Texas, United States, 79905

Research Site

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Salt Lake City, Utah, United States, 84107

Research Site

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Charlottesville, Virginia, United States, 22908

Research Site

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Calgary, Alberta, Canada, T2N 1N4

Research Site

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Brampton, Ontario, Canada, L6R 3J9

Research Site

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Ottawa, Ontario, Canada, K1H 8L6

Research Site

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Ottawa, Ontario, Canada, K1Y 4E9

Research Site

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Toronto, Ontario, Canada, M4N 3M5

Research Site

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Lévis, Quebec, Canada, G6V 3Z1

Research Site

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Montreal, Quebec, Canada, H1T 2M4

Research Site

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Montreal, Quebec, Canada, H2W 1S6

Research Site

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Montreal, Quebec, Canada, H2X 3E4

Research Site

Recruiting

Québec, Quebec, Canada, G1V 4G5

Research Site

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

More Information

Sponsor

AstraZeneca

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • Acute Respiratory Failure
  • Acute Respiratory Distress Syndrome
  • Viral lung infection
  • Tozorakimab
  • Supplemental Oxygen
  • IL-33
  • COVID-19
  • SARS-CoV-2
  • Coronavirus Infections
  • Virus Diseases
  • SARS Coronavirus
  • MEDI3506
  • Respiratory Tract Infections
  • Infections
  • Lung Diseases
  • Influenza

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-28.