Health Condition 1: J398- Other specified diseases of upperrespiratory tract
Conditions
Interventions
Intervention1: Tozorakimab: 150 mg/mL, Single dose 300 mg (2 mL) given at randomisation (1-time dose), IV injection
Control Intervention1: Placebo: Matching volume (2 mL) to Tozorakimub and single dos
Sponsors
AstraZeneca Pharma India Ltd
AstraZeneca AB
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: Age 1. Adult participants >= 18 years old at the time of signing the ICF. Type of Participant and Disease Characteristics 2. Patients hospitalised with viral lung infection. Note: Suspected viral aetiology is acceptable to meet this criterion. 3. Hypoxaemia requiring treatment with supplemental O2, consistent with WHO Clinical Progression Scale for Disease Progression score of 5 and 6. Note: Hypoxemia is defined as SpO2 6 L/min or non-invasive ventilation will be considered to have met this inclusion criterion regardless of SpO2 levels. 4. 5.
Exclusion criteria
Exclusion criteria: Medical Conditions 1 Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or pulmonary sepsis. Bacterial co infection is allowed, unless, in the opinion of the investigator, bacterial infection defines the severity of the participants condition. 2 Hypoxaemia caused primarily by extrapulmonary insult (eg, multiorgan failure, shock, or sepsis) or by lung injury of non infective aetiology (eg, trauma, chemical injury, etc). 3 Ongoing or impending IMV/ECMO at randomisation (ie, WHO Clinical Progression Scale score >= 7). 4 Any comorbid condition that, in the opinion of the investigator, is likely to result in death within 3 months from randomisation. 5 Anticipated recovery and discharge from the hospital within 24 hours of randomisation. 6 Active tuberculosis defined as requiring current treatment. 7 Known unstable cardiovascular disease (eg, unstable chronic heart failure NYHA III-IV, recent myocardial infarction or stroke within 3 months, or uncontrolled ventricular arrythmia) that in the investigator s judgement may put the participant at risk or negatively affect the outcome of the study. 8 Known absolute neutrophil count 9 Untreated HIV. Known history of active hepatitis B or C (treated and controlled hepatitis is allowed). 10 Known history of active severe inflammatory bowel disease or colitis (including Crohn disease or ulcerative colitis). 11 Malignancy, current or within the past 5 years, except for adequately treated non invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment. 12 Any disorder that is not stable in the opinion of the investigator, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious (including risk factors for viral lung infection), endocrine, metabolic, haematological, immune, psychiatric, or major physical impairment and could: a. affect the safety of the participant throughout the study, b. influence the findings of the study or their interpretation, c. impede the participant s ability to complete the entire duration of the study. Prior/Concomitant Therapy 13 Use of long-term oxygen therapy for pre-existing conditions. 14 Chronic treatment with TNF inhibitors, Janus kinase inhibitors or interferon gamma. Wash-out period of 4 weeks or 5 half-lives (whichever is longer) is required prior to enrolment. 15 Current treatment with any investigational medication. Wash-out period of 4 weeks or 5 half-lives (whichever is longer) is required prior to prior to enrolment. 16 Participants who have previously received tozorakimab. 17 Known history of: a. anaphylaxis to any other biologic therapy, b. severe reaction to any medication including biologic agents or human gamma globulin therapy, c. allergy or reaction to any component of the study intervention formulation. Contraception 18 Pregnant and lactating participants. 19 Male participants who are sexually active with a FOCBP and participants that are FOCBP who are sexually active with a male partner, unless they agree to use highly effective contraceptive methods from enrolment throughout the study and until at least 14 weeks after last dose of IP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of tozorakimab versus placebo as add on to SoC in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO by Day 60Timepoint: Proportion of participants who die or progress to IMV/ECMO by Day 60 (WHO CPS score â?¥ 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of tozorakimab versus placebo as add-on to SoC on all-cause mortality by Day 60Timepoint: Proportion of participants who die by Day 60;To evaluate the effect of tozorakimab versus placebo as add-on to SoC on ICU stayTimepoint: Number of days alive and outside of ICU over 60 day period;To evaluate the effect of tozorakimab versus placebo as add-on to SoC on the duration of oxygen supplementationTimepoint: Number of days alive and free of supplemental oxygen over 60 day period;To evaluate the effect of tozorakimab versus placebo as add-on to SoC on prolonging time to death or IMV/ECMOTimepoint: Time to death or progression to IMV/ECMO Proportion of participants who die or progress to IMV/ECMO by Day 28 ;To evaluate the effect of tozorakimab versus placebo as add-on to SoC on prolonging time to deathTimepoint: Time to death (all cause) Proportion of participants who die by Day 28 ;To evaluate the effect of tozorakimab versus placebo as add-on to SoC on ventilator useTimepoint: Number of days alive and free of IMV/ECMO (WHO CPS score 7) over 60 day period Number of days alive and ventilator free (WHO CPS score 6) over 60 day period;To evaluate the effect of tozorakimab versus placebo as add-on to SoC on ICU admissionsTimepoint: Proportion of participants with ICU admission or death by Day 60 Proportion of participants with ICU admission or death by Day 28 ;To evaluate the effect of tozorakimab versus placebo as add-on to SoC on duration of hospitalisationTimepoint: Proportion of participants alive and discharged by Day 28 Proportion of participants alive and discharged by Day 60 Time to discharge (time to WHO CPS score â?¤ 3) Time to being off supplemental oxygen (time to WHO CPS score â?¤ 4) ;To evaluate the effect of tozorakimab as add-on to SoC on clinical status as assessed by the Investigator using WHO 10-category ordinal Clinical Progression Scale by Day 60Timepoint: WHO Clinical Progression Scale rank-based comparison - 60 Day | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Peru, Philippines, Poland, Republic of Korea, Romania, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactMr Tapankumar M Shah
AstraZeneca Pharma India Ltd.
Outcome results
None listed