Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory FailureThe 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation 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.
Study Location
Research Site
Research SiteNew Westminster, British Columbia
Canada
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Research Site
Research SiteLevis, Quebec
Canada
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Research Site
Research SiteSaskatoon, Saskatchewan
Canada
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Research Site
Research SiteCalgary, Alberta
Canada
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Research Site
Research SiteToronto, Ontario
Canada
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Research Site
Research SiteMontreal, Quebec
Canada
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Research Site
Research SiteWinnipeg, Manitoba
Canada
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Research Site
Research SiteMontreal, Quebec
Canada
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Research Site
Research SiteBrampton, Ontario
Canada
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Research Site
Research SiteMontreal, Quebec
Canada
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- Study Sponsored By
- AstraZeneca
- Participants Required
- More Information
- Study ID:
NCT05624450