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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05624450




Registration number
NCT05624450
Ethics application status
Date submitted
11/11/2022
Date registered
22/11/2022
Date last updated
10/05/2024

Titles & IDs
Public title
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Scientific 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
Secondary ID [1] 0 0
2022-003107-15
Secondary ID [2] 0 0
D9185C00001
Universal Trial Number (UTN)
Trial acronym
TILIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Viral Lung Infection and Acute Respiratory Failure 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tozorakimab
Treatment: Drugs - Placebo

Experimental: Tozorakimab - Approximately 2902 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1451) will receive a single dose of tozorakimab.

Placebo Comparator: Placebo - Approximately 2902 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1451) will receive matching placebo.


Treatment: Drugs: Tozorakimab
Single IV dose of tozorakimab on Day 1.

Treatment: Drugs: Placebo
Single IV dose of matching placebo on Day 1.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
Timepoint [1] 0 0
by Day 28
Secondary outcome [1] 0 0
Proportion of participants who die
Timepoint [1] 0 0
by Day 60
Secondary outcome [2] 0 0
Number of days alive and outside of Intensive Care Unit (ICU)
Timepoint [2] 0 0
over 28 day period
Secondary outcome [3] 0 0
Number of days alive and free of supplemental oxygen
Timepoint [3] 0 0
over 28 day period
Secondary outcome [4] 0 0
Time to death or progression to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
Timepoint [4] 0 0
over 28 day and 60 day period
Secondary outcome [5] 0 0
Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
Timepoint [5] 0 0
by Day 60
Secondary outcome [6] 0 0
Time to death (all cause)
Timepoint [6] 0 0
over 28 day and 60 day period
Secondary outcome [7] 0 0
Proportion of participants who die
Timepoint [7] 0 0
by Day 28
Secondary outcome [8] 0 0
Number of days alive and free of Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)
Timepoint [8] 0 0
over 28 day and 60 day period
Secondary outcome [9] 0 0
Number of days alive and ventilator free
Timepoint [9] 0 0
over 28 day and 60 day period
Secondary outcome [10] 0 0
Proportion of participants with Intensive Care Unit (ICU) admission or death
Timepoint [10] 0 0
by Day 28
Secondary outcome [11] 0 0
Proportion of participants with Intensive Care Unit (ICU) admission or death
Timepoint [11] 0 0
by Day 60
Secondary outcome [12] 0 0
Proportion of participants alive and discharged
Timepoint [12] 0 0
by Day 28
Secondary outcome [13] 0 0
Proportion of participants alive and discharged
Timepoint [13] 0 0
by Day 60
Secondary outcome [14] 0 0
Time to discharge
Timepoint [14] 0 0
over 28 day and 60 day period
Secondary outcome [15] 0 0
Time to being off supplemental oxygen
Timepoint [15] 0 0
over 28 day and 60 day period
Secondary outcome [16] 0 0
World Health Organization (WHO) 10-category ordinal Clinical Progression Scale
Timepoint [16] 0 0
by Day 60
Secondary outcome [17] 0 0
Incidence of anti-drug antibodies
Timepoint [17] 0 0
over 60 day period
Secondary outcome [18] 0 0
Baseline serum interleukin-33/soluble Suppression of Tumorgenicity 2 (IL-33/sST2) complex levels relative to primary endpoint
Timepoint [18] 0 0
Day 1

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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 participant's condition.

- Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of
non-infective aetiology.

- Ongoing IMV/ECMO at randomisation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/03/2025
Actual
Sample size
Target
2902
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Bedford Park
Recruitment hospital [3] 0 0
Research Site - New Lambton Heights
Recruitment hospital [4] 0 0
Research Site - Port Macquarie
Recruitment hospital [5] 0 0
Research Site - South Brisbane
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment outside Australia
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United States of America
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Kawasaki-shi
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Kumagaya-shi
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Kumamoto-shi
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Kusatsu-shi
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Kyoto-shi
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Maebashi-shi
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Meguro-ku
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Mitaka-shi
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Nagoya-shi
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Japan
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Nakagami-gun
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Nerima-ku
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Okayama-shi
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Okazaki-shi
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Omuta-shi
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Osaka-shi
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Sapporo-shi
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Japan
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Shinagawa-ku
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Japan
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Shinjuku-ku
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Japan
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Suita-shi
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Japan
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Tachikawa-shi
Country [198] 0 0
Japan
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Takamatsu-shi
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Japan
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Urasoe-shi
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Japan
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Ureshino-shi
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Japan
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Yokohama-shi
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Korea, Republic of
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Daegu
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Korea, Republic of
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Jeonju
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Korea, Republic of
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Seoul
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Malaysia
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Kota Kinabalu
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuantan
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Malaysia
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Kubang Kerian
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Malaysia
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Melaka
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Malaysia
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Petaling Jaya
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05624450
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05624450