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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 4076598, Alabama 4829764 36608

Research Site
Phoenix 5308655, Arizona 5551752 85008

Research Site
Phoenix 5308655, Arizona 5551752 85013

Research Site
Tucson 5318313, Arizona 5551752 85719

Research Site
Chula Vista 5336899, California 5332921 91911

Research Site
Fresno 5350937, California 5332921 93701

Research Site
Los Angeles 5368361, California 5332921 90027

Research Site
Newport Beach 5376890, California 5332921 92663

Research Site
Torrance 5403022, California 5332921 90505

Research Site
Colorado Springs 5417598, Colorado 5417618 80909

Research Site
Washington D.C. 4140963, District of Columbia 4138106 20037

Research Site
Bradenton 4148708, Florida 4155751 34209

Research Site
Gainesville 4156404, Florida 4155751 32611

Research Site
Jacksonville 4160021, Florida 4155751 32224

Research Site
Lakeland 4161438, Florida 4155751 33805

Research Site
Tampa 4174757, Florida 4155751 33617

Research Site
Atlanta 4180439, Georgia 4197000 30322

Research Site
Boise 5586437, Idaho 5596512 83702

Research Site
Elmhurst 4891010, Illinois 4896861 60126

Research Site
Evanston 4891382, Illinois 4896861 60201

Research Site
Fort Wayne 4920423, Indiana 4921868 46804

Research Site
Iowa City 4862034, Iowa 4862182 52242

Research Site
Kansas City 4273837, Kansas 4273857 66160

Research Site
Louisville 4299276, Kentucky 6254925 40202

Research Site
Baton Rouge 4315588, Louisiana 4331987 70808

Research Site
New Orleans 4335045, Louisiana 4331987 70121

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Shreveport 4341513, Louisiana 4331987 71103

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Annapolis 4347242, Maryland 4361885 21401

Research Site
Silver Spring 4369596, Maryland 4361885 20910

Research Site
Springfield 4951788, Massachusetts 6254926 01199

Research Site
Worcester 4956184, Massachusetts 6254926 01655

Research Site
Detroit 4990729, Michigan 5001836 48202

Research Site
Royal Oak 5007804, Michigan 5001836 48073

Research Site
Saint Paul 5045360, Minnesota 5037779 55101

Research Site
Columbia 4381982, Missouri 4398678 65212

Research Site
Kansas City 4393217, Missouri 4398678 64108

Research Site
St Louis 4407066, Missouri 4398678 63110

Research Site
Brooklyn 5110302, New York 5128638 11203

Research Site
New York 5128581, New York 5128638 10039

Research Site
Potsdam 5132103, New York 5128638 13676

Research Site
Chapel Hill 4460162, North Carolina 4482348 27514

Research Site
Greenville 4469160, North Carolina 4482348 27834

Research Site
Winston-Salem 4499612, North Carolina 4482348 27157

Research Site
Columbus 4509177, Ohio 5165418 43210

Research Site
Oklahoma City 4544349, Oklahoma 4544379 73104

Research Site
Corvallis 5720727, Oregon 5744337 97330

Research Site
Greenville 4580543, South Carolina 4597040 29605

Research Site
Sioux Falls 5231851, South Dakota 5769223 57105

Research Site
Dallas 4684888, Texas 4736286 75203

Research Site
Dallas 4684888, Texas 4736286 75204

Research Site
El Paso 5520993, Texas 4736286 79905

Research Site
Salt Lake City 5780993, Utah 5549030 84107

Research Site
Charlottesville 4752031, Virginia 6254928 22908

Research Site
Green Bay 5254962, Wisconsin 5279468 54311

Research Site
Milwaukee 5263045, Wisconsin 5279468 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

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.