A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA)

Conditions

Severe viral lung infections

Brief summary

Proportion of participants who die or progress to IMV/ECMO by Day 28

Detailed description

1. Proportion of participants who die by Day 60, 2. Number of days alive and outside of ICU over 28 day period, 3. Number of days alive and free of supplemental oxygen over 28 day period, 4. Time to death or progression to IMV/ECMO, 5. Proportion of participants who die or progress to IMV/ECMO by Day 60, 6. Time to death (all cause), 7. Proportion of participants who die by Day 28, 8. Number of days alive and free of IMV/ECMO over 28 day and 60 day period, 9. Number of days alive and ventilator free over 28 day and 60 day period, 10. Proportion of participants with ICU admission or death by Day 28 and Day 60, 11. Proportion of participants alive and discharged by Day 28 and Day 60, 12. Time to discharge, 13. Time to being off supplemental oxygen, 14. WHO CPS score rank-based comparison, 15. Presence of anti-drug antibodies, 16. Baseline serum biomarker levels relative to primary endpoint

Related papers

No related papers found yet.

Interventions

DRUGTozorakimab-placebo

DRUGTozorakimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants who die or progress to IMV/ECMO by Day 28	—

Secondary

Measure	Time frame
1. Proportion of participants who die by Day 60, 2. Number of days alive and outside of ICU over 28 day period, 3. Number of days alive and free of supplemental oxygen over 28 day period, 4. Time to death or progression to IMV/ECMO, 5. Proportion of participants who die or progress to IMV/ECMO by Day 60, 6. Time to death (all cause), 7. Proportion of participants who die by Day 28, 8. Number of days alive and free of IMV/ECMO over 28 day and 60 day period, 9. Number of days alive and ventilator free over 28 day and 60 day period, 10. Proportion of participants with ICU admission or death by Day 28 and Day 60, 11. Proportion of participants alive and discharged by Day 28 and Day 60, 12. Time to discharge, 13. Time to being off supplemental oxygen, 14. WHO CPS score rank-based comparison, 15. Presence of anti-drug antibodies, 16. Baseline serum biomarker levels relative to primary endpoint	—

Measure

Time frame

1. Proportion of participants who die by Day 60, 2. Number of days alive and outside of ICU over 28 day period, 3. Number of days alive and free of supplemental oxygen over 28 day period, 4. Time to death or progression to IMV/ECMO, 5. Proportion of participants who die or progress to IMV/ECMO by Day 60, 6. Time to death (all cause), 7. Proportion of participants who die by Day 28, 8. Number of days alive and free of IMV/ECMO over 28 day and 60 day period, 9. Number of days alive and ventilator free over 28 day and 60 day period, 10. Proportion of participants with ICU admission or death by Day 28 and Day 60, 11. Proportion of participants alive and discharged by Day 28 and Day 60, 12. Time to discharge, 13. Time to being off supplemental oxygen, 14. WHO CPS score rank-based comparison, 15. Presence of anti-drug antibodies, 16. Baseline serum biomarker levels relative to primary endpoint

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Countries

Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Poland, Romania, Slovakia, Spain, Sweden

Outcome results

None listed