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

Phase 3RecruitingNCT05624450

AstraZeneca2,870 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

2,870

Conditions

Viral Lung Infection and Acute Respiratory Failure

Interventions

TozorakimabDRUG

Single IV dose of tozorakimab on Day 1.

PlaceboDRUG

Single IV dose of matching placebo on Day 1.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (451)

Outcomes

Primary Outcomes

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 28

Secondary Outcomes

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 60

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 period

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 period

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 period

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 add-on to Standard of Care (SoC) on prolonging time to death or IMV/ECMO.

Time frame: by Day 60

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

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Research Site

Mobile, Alabama, United States

RECRUITING

Research Site

Phoenix, Arizona, United States

RECRUITING

Research Site

Phoenix, Arizona, United States

RECRUITING

Research Site

Tucson, Arizona, United States

RECRUITING

Research Site

Chula Vista, California, United States

RECRUITING

Research Site

Fresno, California, United States

RECRUITING

Research Site

La Mesa, California, United States

WITHDRAWN

Research Site

Los Angeles, California, United States

RECRUITING

Research Site

Newport Beach, California, United States

RECRUITING

Research Site

Torrance, California, United States

RECRUITING

...and 441 more locations

Time to death (all cause)

To evaluate the effect of Tozorakimab versus Placebo as add-on to Standard of Care (SoC) on prolonging time to death.

Time frame: over 28 day and 60 day period

Proportion of participants who die

To evaluate the effect of Tozorakimab versus Placebo as add-on to Standard of Care (SoC) on prolonging time to death.

Time frame: by Day 28

Number of days alive and free of 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 ventilator use.

Time frame: over 28 day and 60 day period

Number of days alive and ventilator free

To evaluate the effect of Tozorakimab versus placebo as add-on to Standard of Care (SoC) on ventilator use.

Time frame: over 28 day and 60 day period

Proportion of participants with Intensive Care Unit (ICU) admission or death

To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU admissions.

Time frame: by Day 28

Proportion of participants with Intensive Care Unit (ICU) admission or death

To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU admissions.

Time frame: by Day 60

Proportion of participants alive and discharged

To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.

Time frame: by Day 28

Proportion of participants alive and discharged

To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.

Time frame: by Day 60

Time to discharge

To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.

Time frame: over 28 day and 60 day period

Time to being off supplemental oxygen

To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.

Time frame: over 28 day and 60 day period

World Health Organization (WHO) 10-category ordinal Clinical Progression Scale

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).

Time frame: by Day 60

Presence of anti-drug antibodies

To evaluate the immunogenicity (presence of tozorakimab anti-drug antibodies in blood serum) in participants with viral lung infection requiring supplemental oxygen.

Time frame: over 60 day period

Baseline serum interleukin-33/soluble Suppression of Tumorgenicity 2 (IL-33/sST2) complex levels relative to primary endpoint

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).

Time frame: Day 1