Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tozorakimab
DrugSingle IV dose of tozorakimab on Day 1.
Placebo
DrugSingle IV dose of matching placebo on Day 1.
Treatment groups
3,527 Participants
are divided into 2 treatment groupsGroup A: TozorakimabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
To evaluate the effect of tozorakimab versus placebo as an add on to Standard of Care (SoC) in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO.
Time frame
by Day 28Secondary outcomes
1
Proportion of participants who die
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on all-cause mortality.
Time frame
by Day 602
Number of days alive and outside of Intensive Care Unit (ICU)
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU stay.
Time frame
over 28 day period3
Number of days alive and free of supplemental oxygen
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on the duration of oxygen supplementation.
Time frame
over 28 day period4
Time to death or progression to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on prolonging time to death or IMV/ECMO.
Time frame
over 28 day and 60 day periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov