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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05624450
Ethics application status
Date submitted
11/11/2022
Date registered
22/11/2022

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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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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Shinagawa-ku
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Shinjuku-ku
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Suita-shi
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Tachikawa-shi
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Takamatsu-shi
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Urasoe-shi
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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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Hue

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05624450