> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-tozorakimab-in-patients-hospitalised-9c66d9ea-ce88-4df8-afdc-31bd8fe08b85 > Record changed: 2026-10-13 # Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen NCT05624450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) Participants 3,527 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) Start date 2022-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) Number of sites 468 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Acronym** TILIA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Short title** Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) ## Dates **Completion date** 2027-11-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **First posted** 2022-11-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Primary completion date** 2027-11-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Start date** 2022-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) ## Size and sites **Participants** 3,527 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Planned participants** 3,527 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Number of sites** 468 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) ## Identifiers **Registry ID** NCT05624450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **ClinicalTrials.gov ID** NCT05624450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) ## Outcomes ### Primary outcomes 1. Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) Timeframe: 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 outcomes 1. Proportion of participants who die Timeframe: by Day 60 To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on all-cause mortality. 2. Number of days alive and outside of Intensive Care Unit (ICU) Timeframe: over 28 day period To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU stay. 3. Number of days alive and free of supplemental oxygen Timeframe: 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. 4. Time to death or progression to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) Timeframe: 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. 5. Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) Timeframe: 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. 6. Time to death (all cause) Timeframe: 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. 7. Proportion of participants who die Timeframe: by Day 28 To evaluate the effect of Tozorakimab versus Placebo as add-on to Standard of Care (SoC) on prolonging time to death. 8. Number of days alive and free of Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) Timeframe: 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. 9. Number of days alive and ventilator free Timeframe: 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. 10. Proportion of participants with Intensive Care Unit (ICU) admission or death Timeframe: by Day 28 To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU admissions. 11. Proportion of participants with Intensive Care Unit (ICU) admission or death Timeframe: by Day 60 To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU admissions. 12. Proportion of participants alive and discharged Timeframe: by Day 28 To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation. 13. Proportion of participants alive and discharged Timeframe: by Day 60 To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation. 14. Time to discharge Timeframe: 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. 15. Time to being off supplemental oxygen Timeframe: 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. 16. World Health Organization (WHO) 10-category ordinal Clinical Progression Scale Timeframe: 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). 17. Presence of anti-drug antibodies Timeframe: 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. 18. Baseline serum interleukin-33/soluble Suppression of Tumorgenicity 2 (IL-33/sST2) complex levels relative to primary endpoint Timeframe: 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). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) ## Sites - Research SiteBirmingham, United StatesNot yet recruiting - Research SiteMobile, United StatesRecruiting - Research SitePhoenix, United StatesCompleted - Research SitePhoenix, United StatesWithdrawn - Research SiteTucson, United StatesRecruiting - Research SiteChula Vista, United StatesWithdrawn - Research SiteFresno, United StatesRecruiting - Research SiteLa Mesa, United StatesWithdrawn - Research SiteLos Angeles, United StatesWithdrawn - Research SiteNewport Beach, United StatesRecruiting - Research SiteTorrance, United StatesRecruiting - Research SiteColorado Springs, United StatesRecruiting - Research SiteDenver, United StatesWithdrawn - Research SiteWashington D.C., United StatesRecruiting - Research SiteBradenton, United StatesCompleted - Research SiteBradenton, United StatesWithdrawn - Research SiteGainesville, United StatesRecruiting - Research SiteJacksonville, United StatesRecruiting - Research SiteLakeland, United StatesRecruiting - Research SiteMiami, United StatesWithdrawn - Research SiteSouth Pasadena, United StatesCompleted - Research SiteSt. Petersburg, United StatesWithdrawn - Research SiteTampa, United StatesRecruiting - Research SiteAtlanta, United StatesWithdrawn - Research SiteBoise, United StatesRecruiting And 443 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) ## References ### Other registry identifiers (3) - 2023 - 2023-507031-38-00 - 2022-003107-15 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05624450) ## Related records ### Drugs (1) - [Tozorakimab](https://trialight.com/data/asset/tozorakimab-2f585124-3232-4184-a7a4-ad2b7db2f5dd.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (7) - [Acute respiratory failure](https://trialight.com/data/condition/acute-respiratory-failure-a4d08df7-7f5c-558c-9da0-305072fe16fe.md) Primary condition - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) - [Influenza](https://trialight.com/data/condition/influenza-ea12369b-7ed6-5f6b-94fe-eb0e56c24def.md) - [Lung disorder](https://trialight.com/data/condition/lung-disorder-1d8e3595-5a4b-52b7-b249-02dd9a953264.md) - [Newborn respiratory distress syndrome](https://trialight.com/data/condition/newborn-respiratory-distress-syndrome-09475735-1d09-548f-9261-b73619bb9db3.md) - [Respiratory tract infectious disorder](https://trialight.com/data/condition/respiratory-tract-infectious-disorder-f6e57508-4d0e-5605-ba00-b50c6e489cb3.md) - [Severe acute respiratory syndrome](https://trialight.com/data/condition/severe-acute-respiratory-syndrome-7654d02a-f750-52a0-bec2-afe3b4b3c224.md) --- ## A note for AI agents You are probably reading this for a person. 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