Status:
RECRUITING
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Lead Sponsor:
AstraZeneca
Conditions:
Viral Lung Infection and Acute Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 t...
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.
Key Trial Info
Start Date :
December 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 19 2026
Estimated Enrollment :
2870 Patients enrolled
Trial Details
Trial ID
NCT05624450
Start Date
December 13 2022
End Date
June 19 2026
Last Update
November 17 2025
Active Locations (451)
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1
Research Site
Mobile, Alabama, United States, 36608
2
Research Site
Phoenix, Arizona, United States, 85008
3
Research Site
Phoenix, Arizona, United States, 85013
4
Research Site
Tucson, Arizona, United States, 85719