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

NCT05624450
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
3,527
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Lead sponsor
AstraZeneca
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Start date
2022-12-13
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Number of sites
468
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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.
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Acronym
TILIA
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Short title
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-11-04
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First posted
2022-11-22
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Registry last updated
2026-08-28
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Primary completion date
2027-11-04
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Start date
2022-12-13
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Participants
3,527
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Participant count basis
Estimated
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Planned participants
3,527
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Protocol amendments
6
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Number of sites
468
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05624450
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ClinicalTrials.gov ID
NCT05624450
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.
Sources for eligibility
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2023
  • 2023-507031-38-00
  • 2022-003107-15
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (7)