RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-12-13
Study Completion:2025-03-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05624450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult participants ≥ 18 years old at the time of signing the informed consent form.
  2. * Patients hospitalised with viral lung infection.
  3. * Hypoxaemia requiring treatment with supplemental O2.
  1. * 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.
  2. * Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology.
  3. * Ongoing IMV/ECMO at randomisation.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Research Site
Mobile, Alabama, 36608
United States
Research Site
Phoenix, Arizona, 85008
United States
Research Site
Phoenix, Arizona, 85013
United States
Research Site
Tucson, Arizona, 85719
United States
Research Site
Chula Vista, California, 91911
United States
Research Site
Fresno, California, 93701
United States
Research Site
La Mesa, California, 91942
United States
Research Site
Los Angeles, California, 90027
United States
Research Site
Newport Beach, California, 92663
United States
Research Site
Torrance, California, 90505
United States
Research Site
Colorado Springs, Colorado, 80909
United States
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Denver, Colorado, 80206
United States
Research Site
Washington, District of Columbia, 20037
United States
Research Site
Bradenton, Florida, 34209
United States
Research Site
Bradenton, Florida, 34209
United States
Research Site
Gainesville, Florida, 32611
United States
Research Site
Lakeland, Florida, 33805
United States
Research Site
Miami, Florida, 33144
United States
Research Site
Saint Petersburg, Florida, 33709
United States
Research Site
South Pasadena, Florida, 33707
United States
Research Site
Tampa, Florida, 33617
United States
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Atlanta, Georgia, 30322
United States
Research Site
Boise, Idaho, 83702
United States
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Chicago, Illinois, 60612
United States
Research Site
Elmhurst, Illinois, 60126
United States
Research Site
Evanston, Illinois, 60201
United States
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Fort Wayne, Indiana, 46804
United States
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Iowa City, Iowa, 52242
United States
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Kansas City, Kansas, 66160
United States
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Louisville, Kentucky, 40202
United States
Research Site
Baton Rouge, Louisiana, 70808
United States
Research Site
New Orleans, Louisiana, 70121
United States
Research Site
Shreveport, Louisiana, 71103
United States
Research Site
Annapolis, Maryland, 21401
United States
Research Site
Silver Spring, Maryland, 20910
United States
Research Site
Springfield, Massachusetts, 01199
United States
Research Site
Worcester, Massachusetts, 01655
United States
Research Site
Detroit, Michigan, 48202
United States
Research Site
Detroit, Michigan, 48202
United States
Research Site
Royal Oak, Michigan, 48073
United States
Research Site
Saint Paul, Minnesota, 55101
United States
Research Site
Columbia, Missouri, 65212
United States
Research Site
Saint Louis, Missouri, 63110
United States
Research Site
Brooklyn, New York, 11203
United States
Research Site
New York, New York, 10016
United States
Research Site
New York, New York, 10039
United States
Research Site
Potsdam, New York, 13676
United States
Research Site
Chapel Hill, North Carolina, 27514
United States
Research Site
Greenville, North Carolina, 27834
United States
Research Site
Winston-Salem, North Carolina, 27157
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Oklahoma City, Oklahoma, 73104
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Providence, Rhode Island, 02903
United States
Research Site
Greenville, South Carolina, 29601
United States
Research Site
Sioux Falls, South Dakota, 57105
United States
Research Site
Dallas, Texas, 75203
United States
Research Site
Dallas, Texas, 75204
United States
Research Site
El Paso, Texas, 79905
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Houston, Texas, 77090
United States
Research Site
Salt Lake City, Utah, 84107
United States
Research Site
Charlottesville, Virginia, 22908
United States
Research Site
Green Bay, Wisconsin, 54311
United States
Research Site
Milwaukee, Wisconsin, 53295
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-13
Study Completion Date2025-03-17

Study Record Updates

Study Start Date2022-12-13
Study Completion Date2025-03-17

Terms related to this study

Keywords Provided by Researchers

  • Acute Respiratory Failure
  • Acute Respiratory Distress Syndrome
  • Viral lung infection
  • Tozorakimab
  • Supplemental Oxygen
  • IL-33
  • COVID-19
  • SARS-CoV-2
  • Coronavirus Infections
  • Virus Diseases
  • SARS Coronavirus
  • MEDI3506
  • Respiratory Tract Infections
  • Infections
  • Lung Diseases
  • Influenza

Additional Relevant MeSH Terms

  • Viral Lung Infection and Acute Respiratory Failure