Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

Purpose

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.

Condition

  • Viral Lung Infection and Acute Respiratory Failure

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or pulmonary sepsis. 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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tozorakimab 		Approximately 2902 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1451) will receive a single dose of tozorakimab.
  • Drug: Tozorakimab
    Single IV dose of tozorakimab on Day 1.
    Other names:
    • MEDI3506
Placebo Comparator
Placebo 		Approximately 2902 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1451) will receive matching placebo.
  • Drug: Placebo
    Single IV dose of matching placebo on Day 1.

Recruiting Locations

Research Site
Phoenix, Arizona 85013

Research Site
Tucson, Arizona 85719

Research Site
Chula Vista, California 91911

Research Site
Fresno, California 93701

Research Site
Newport Beach, California 92663

Research Site
Torrance, California 90505

Research Site
Washington, District of Columbia 20037

Research Site
Bradenton, Florida 34209

Research Site
Lakeland, Florida 33805

Research Site
Atlanta, Georgia 30322

Research Site
Boise, Idaho 83702

Research Site
Chicago, Illinois 60612

Research Site
Elmhurst, Illinois 60126

Research Site
Evanston, Illinois 60201

Research Site
Fort Wayne, Indiana 46804

Research Site
Iowa City, Iowa 52242

Research Site
Kansas City, Kansas 66160

Research Site
New Orleans, Louisiana 70121

Research Site
Shreveport, Louisiana 71103

Research Site
Annapolis, Maryland 21401

Research Site
Silver Spring, Maryland 20910

Research Site
Springfield, Massachusetts 01199

Research Site
Worcester, Massachusetts 01655

Research Site
Detroit, Michigan 48202

Research Site
Columbia, Missouri 65212

Research Site
Brooklyn, New York 11203

Research Site
New York, New York 10039

Research Site
Potsdam, New York 13676

Research Site
Chapel Hill, North Carolina 27514

Research Site
Greenville, North Carolina 27834

Research Site
Winston-Salem, North Carolina 27157

Research Site
Providence, Rhode Island 02903

Research Site
Sioux Falls, South Dakota 57105

Research Site
Dallas, Texas 75203

Research Site
Houston, Texas 77030

Research Site
Charlottesville, Virginia 22908

Research Site
Green Bay, Wisconsin 54311

Research Site
Milwaukee, Wisconsin 53295

More Details

NCT ID
NCT05624450
Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com