NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Viral Lung Infection and Acute Respiratory Failure

Interventions: Tozorakimab, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (464)

Mobile, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Chula Vista, California, United States
Fresno, California, United States
La Mesa, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Torrance, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Bradenton, Florida, United States
Bradenton, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Lakeland, Florida, United States
Miami, Florida, United States
South Pasadena, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Elmhurst, Illinois, United States
Evanston, Illinois, United States
Fort Wayne, Indiana, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
+ 434 more on CT.gov