Evaluating Tozorakimab for Patients with Viral Lung Infections Needing Oxygen
Official title: 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
Run by AstraZeneca · NCT05624450 · Data updated 2026-11-12
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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3527 (estimated) |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | tozorakimab |
| Locations | 473 sites (Birmingham, Alabama and 472 other locations) |
| Status | Recruiting |
| Started | December 13, 2022 |
| Main results expected | November 4, 2027 |
| Study ends | November 4, 2027 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT05624450 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are hospitalized with viral lung infections and require supplemental oxygen due to hypoxaemia.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Mobile, Alabama, United States Recruiting -
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Tucson, Arizona, United States Recruiting -
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Fresno, California, United States Recruiting -
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Newport Beach, California, United States Recruiting -
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Torrance, California, United States Recruiting -
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Colorado Springs, Colorado, United States Recruiting
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Washington D.C., District of Columbia, United States Recruiting -
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Gainesville, Florida, United States Recruiting -
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Jacksonville, Florida, United States Recruiting -
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Lakeland, Florida, United States Recruiting -
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Evanston, Illinois, United States Recruiting -
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Louisville, Kentucky, United States Recruiting -
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Baton Rouge, Louisiana, United States Recruiting -
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Kansas City, Missouri, United States Recruiting -
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Columbus, Ohio, United States Recruiting -
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Toledo, Ohio, United States Recruiting -
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Oklahoma City, Oklahoma, United States Recruiting -
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Greenville, South Carolina, United States Recruiting -
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Salt Lake City, Utah, United States Recruiting -
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Charlottesville, Virginia, United States Recruiting -
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La Plata, Argentina Recruiting -
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Munro, Argentina Recruiting -
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Adelaide, Australia Recruiting -
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Bedford Park, Australia Recruiting -
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Port Macquarie, Australia Recruiting -
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South Brisbane, Australia Recruiting -
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Kortrijk, Belgium Recruiting -
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Ottignies, Belgium Recruiting -
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Roeselare, Belgium Recruiting -
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Yvoir, Belgium Recruiting -
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Campinas, Brazil Recruiting -
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Caxias do Sul, Brazil Recruiting -
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Jaú, Brazil Recruiting -
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Natal, Brazil Recruiting -
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Passo Fundo, Brazil Recruiting -
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Porto Alegre, Brazil Recruiting -
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Rio de Janeiro, Brazil Recruiting -
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São Caetano do Sul, Brazil Recruiting
+423 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Long-term safety of Tozorakimab in COPD patients with prior exacerbations
This study tests two long-term dosing regimens of tozorakimab in people with COPD who have a history of flare-ups and who completed earlier studies.
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Assessing the effects of tozorakimab in adults with uncontrolled asthma
This study is testing a new asthma treatment called tozorakimab to see if it can help adults who still have asthma problems despite using their current medications.
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Different doses of Ingavirin Forte capsules for adults with influenza or other acute respiratory infections.
This trial will see if different doses of Ingavirin Forte capsules help adults (18–65) with PCR-confirmed influenza or other acute respiratory viral infections.
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Efficacy and safety of Raphamin for treating respiratory infections in children
This study is testing if a new medicine called Raphamin can help children aged 3 to 12 with respiratory infections feel better and recover faster.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.