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

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.

Conditions

Viral Lung Infection and Acute Respiratory Failure

Study Overview

Study Details

Study overview

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.

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

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

Condition
Viral Lung Infection and Acute Respiratory Failure
Intervention / Treatment

-

Contacts and Locations

Mobile

Research Site, Mobile, Alabama, United States, 36608

Phoenix

Research Site, Phoenix, Arizona, United States, 85008

Phoenix

Research Site, Phoenix, Arizona, United States, 85013

Tucson

Research Site, Tucson, Arizona, United States, 85719

Chula Vista

Research Site, Chula Vista, California, United States, 91911

Fresno

Research Site, Fresno, California, United States, 93701

La Mesa

Research Site, La Mesa, California, United States, 91942

Los Angeles

Research Site, Los Angeles, California, United States, 90027

Newport Beach

Research Site, Newport Beach, California, United States, 92663

Torrance

Research Site, Torrance, California, United States, 90505

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2025-03-17