Clinical trial Recruiting at 238 sites Phase 3 Interventional Ages 18 and up

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

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment3527 (estimated)
SponsorAstraZeneca
Industry-sponsored
Drugs / interventionstozorakimab
Locations473 sites (Birmingham, Alabama and 472 other locations)
StatusRecruiting
StartedDecember 13, 2022
Main results expectedNovember 4, 2027
Study endsNovember 4, 2027
Registry record updatedOctober 30, 2026
Trial IDNCT05624450 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

  • Research Site
    Mobile, Alabama, United States
    Recruiting
  • Research Site
    Tucson, Arizona, United States
    Recruiting
  • Research Site
    Fresno, California, United States
    Recruiting
  • Research Site
    Newport Beach, California, United States
    Recruiting
  • Research Site
    Torrance, California, United States
    Recruiting
  • Research Site
    Colorado Springs, Colorado, United States
    Recruiting
Show 44 more locations
  • Research Site
    Washington D.C., District of Columbia, United States
    Recruiting
  • Research Site
    Gainesville, Florida, United States
    Recruiting
  • Research Site
    Jacksonville, Florida, United States
    Recruiting
  • Research Site
    Lakeland, Florida, United States
    Recruiting
  • Research Site
    Tampa, Florida, United States
    Recruiting
  • Research Site
    Boise, Idaho, United States
    Recruiting
  • Research Site
    Evanston, Illinois, United States
    Recruiting
  • Research Site
    Louisville, Kentucky, United States
    Recruiting
  • Research Site
    Baton Rouge, Louisiana, United States
    Recruiting
  • Research Site
    Annapolis, Maryland, United States
    Recruiting
  • Research Site
    Detroit, Michigan, United States
    Recruiting
  • Research Site
    Royal Oak, Michigan, United States
    Recruiting
  • Research Site
    Saint Paul, Minnesota, United States
    Recruiting
  • Research Site
    Kansas City, Missouri, United States
    Recruiting
  • Research Site
    St Louis, Missouri, United States
    Recruiting
  • Research Site
    New York, New York, United States
    Recruiting
  • Research Site
    Winston-Salem, North Carolina, United States
    Recruiting
  • Research Site
    Columbus, Ohio, United States
    Recruiting
  • Research Site
    Toledo, Ohio, United States
    Recruiting
  • Research Site
    Oklahoma City, Oklahoma, United States
    Recruiting
  • Research Site
    Greenville, South Carolina, United States
    Recruiting
  • Research Site
    Dallas, Texas, United States
    Recruiting
  • Research Site
    El Paso, Texas, United States
    Recruiting
  • Research Site
    Salt Lake City, Utah, United States
    Recruiting
  • Research Site
    Charlottesville, Virginia, United States
    Recruiting
  • Research Site
    Buenos Aires, Argentina
    Recruiting
  • Research Site
    La Plata, Argentina
    Recruiting
  • Research Site
    Munro, Argentina
    Recruiting
  • Research Site
    Adelaide, Australia
    Recruiting
  • Research Site
    Bedford Park, Australia
    Recruiting
  • Research Site
    Port Macquarie, Australia
    Recruiting
  • Research Site
    South Brisbane, Australia
    Recruiting
  • Research Site
    Kortrijk, Belgium
    Recruiting
  • Research Site
    Ottignies, Belgium
    Recruiting
  • Research Site
    Roeselare, Belgium
    Recruiting
  • Research Site
    Yvoir, Belgium
    Recruiting
  • Research Site
    Campinas, Brazil
    Recruiting
  • Research Site
    Caxias do Sul, Brazil
    Recruiting
  • Research Site
    Jaú, Brazil
    Recruiting
  • Research Site
    Natal, Brazil
    Recruiting
  • Research Site
    Passo Fundo, Brazil
    Recruiting
  • Research Site
    Porto Alegre, Brazil
    Recruiting
  • Research Site
    Rio de Janeiro, Brazil
    Recruiting
  • Research Site
    São Caetano do Sul, Brazil
    Recruiting

+423 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.