Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
- Conditions
- Viral Lung Infection and Acute Respiratory Failure
- Interventions
- Drug: Placebo
- Registration Number
- NCT05624450
- Lead Sponsor
- AstraZeneca
- 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 to IMV/ECMO.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2870
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tozorakimab Tozorakimab Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab. Placebo Placebo Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1435) will receive matching placebo.
- Primary Outcome Measures
Name Time Method Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) by Day 28 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.
- Secondary Outcome Measures
Name Time Method Proportion of participants who die by Day 28 To evaluate the effect of Tozorakimab versus Placebo as add-on to Standard of Care (SoC) on prolonging time to death.
Number of days alive and outside of Intensive Care Unit (ICU) over 28 day period To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU stay.
Number of days alive and free of supplemental oxygen over 28 day period To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on the duration of oxygen supplementation.
Time to death or progression to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) over 28 day and 60 day period To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on prolonging time to death or IMV/ECMO.
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) by Day 60 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 to death (all cause) over 28 day and 60 day period To evaluate the effect of Tozorakimab versus Placebo as add-on to Standard of Care (SoC) on prolonging time to death.
Number of days alive and free of Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) over 28 day and 60 day period To evaluate the effect of Tozorakimab versus placebo as add-on to Standard of Care (SoC) on ventilator use.
Number of days alive and ventilator free over 28 day and 60 day period To evaluate the effect of Tozorakimab versus placebo as add-on to Standard of Care (SoC) on ventilator use.
Proportion of participants with Intensive Care Unit (ICU) admission or death by Day 60 To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU admissions.
Proportion of participants alive and discharged by Day 60 To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
Time to discharge over 28 day and 60 day period To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
Time to being off supplemental oxygen over 28 day and 60 day period To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.
World Health Organization (WHO) 10-category ordinal Clinical Progression Scale by Day 60 To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on clinical status as assessed by the Investigator using WHO 10-category ordinal Clinical Progression Scale (0 least severe to 10 most severe).
Presence of anti-drug antibodies over 60 day period To evaluate the immunogenicity (presence of tozorakimab anti-drug antibodies in blood serum) in participants with viral lung infection requiring supplemental oxygen.
Baseline serum interleukin-33/soluble Suppression of Tumorgenicity 2 (IL-33/sST2) complex levels relative to primary endpoint Day 1 To evaluate the use of baseline serum IL-33/sST2 complex levels (U/mL) to predict treatment response with tozorakimab versus placebo as add on to Standard of Care (SoC).
Trial Locations
- Locations (1)
Research Site
🇻🇳Hue, Vietnam