Print

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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. - 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

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 2870 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab.
  • Drug: Tozorakimab
    Single IV dose of tozorakimab on Day 1.
    Other names:
    • MEDI3506
Placebo Comparator
Placebo 		Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1435) will receive matching placebo.
  • Drug: Placebo
    Single IV dose of matching placebo on Day 1.

Recruiting Locations

Research Site
Mobile, Alabama 36608

Research Site
Phoenix, Arizona 85008

Research Site
Tucson, Arizona 85719

Research Site
Fresno, California 93701

Research Site
Newport Beach, California 92663

Research Site
Torrance, California 90505

Research Site
Colorado Springs, Colorado 80909

Research Site
Washington D.C., District of Columbia 20037

Research Site
Gainesville, Florida 32611

Research Site
Jacksonville, Florida 32224

Research Site
Lakeland, Florida 33805

Research Site
Tampa, Florida 33617

Research Site
Boise, Idaho 83702

Research Site
Evanston, Illinois 60201

Research Site
Louisville, Kentucky 40202

Research Site
Baton Rouge, Louisiana 70808

Research Site
Annapolis, Maryland 21401

Research Site
Detroit, Michigan 48202

Research Site
Royal Oak, Michigan 48073

Research Site
Saint Paul, Minnesota 55101

Research Site
Kansas City, Missouri 64108

Research Site
St Louis, Missouri 63110

Research Site
New York, New York 10039

Research Site
Winston-Salem, North Carolina 27157

Research Site
Columbus, Ohio 43210

Research Site
Oklahoma City, Oklahoma 73104

Research Site
Greenville, South Carolina 29605

Research Site
Dallas, Texas 75204

Research Site
El Paso, Texas 79905

Research Site
Salt Lake City, Utah 84107

Research Site
Charlottesville, Virginia 22908

More Details

NCT ID
NCT05624450
Status
Recruiting
Sponsor
AstraZeneca

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.