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

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05624450
Collaborator
(none)
2,352
Enrollment
180
Locations
2
Arms
16.9
Anticipated Duration (Months)
13.1
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2352 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 13, 2022
Anticipated Primary Completion Date :
May 9, 2024
Anticipated Study Completion Date :
May 9, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tozorakimab

Up to approximately 2352 participants will be randomized in a 1:1 ratio. Arm 1 (n=up to approximately 1176) will receive a single dose of tozorakimab.

Drug: Tozorakimab
Single IV dose of tozorakimab or matching placebo on Day 1.
Other Names:
  • MEDI3506

    		•
    Placebo Comparator: Placebo

    Up to approximately 2352 participants will be randomized in a 1:1 ratio. Arm 2 (n=up to approximately 1176) will receive matching placebo.

    Drug: Placebo
    Single IV dose of tozorakimab or matching placebo on Day 1.

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO) [by Day 60]

      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 Outcome Measures

    1. Proportion of participants who die [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) [over 60 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 [over 60 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 IMV/ECMO [over 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) [by Day 28]

      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) [over 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 [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) [over 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 [over 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 [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 [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 [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 [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 [over 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 [over 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 [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. Incidence of anti-drug antibodies [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 [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    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 or impending IMV/ECMO at randomisation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Mobile Alabama United States 36608
    2 Research Site Chula Vista California United States 91911
    3 Research Site Newport Beach California United States 92663
    4 Research Site Torrance California United States 90505
    5 Research Site Washington District of Columbia United States 20037
    6 Research Site Bradenton Florida United States 34209
    7 Research Site Saint Petersburg Florida United States 33709
    8 Research Site Atlanta Georgia United States 30322
    9 Research Site Boise Idaho United States 83702
    10 Research Site Chicago Illinois United States 60612
    11 Research Site Elmhurst Illinois United States 60126
    12 Research Site Evanston Illinois United States 60201
    13 Research Site Fort Wayne Indiana United States 46804
    14 Research Site Iowa City Iowa United States 52242
    15 Research Site Shreveport Louisiana United States 71103
    16 Research Site Annapolis Maryland United States 21401
    17 Research Site Silver Spring Maryland United States 20910
    18 Research Site Detroit Michigan United States 48202
    19 Research Site Brooklyn New York United States 11203
    20 Research Site New York New York United States 10039
    21 Research Site Potsdam New York United States 13676
    22 Research Site Chapel Hill North Carolina United States 27514
    23 Research Site Winston-Salem North Carolina United States 27157
    24 Research Site Portland Oregon United States 97239
    25 Research Site Providence Rhode Island United States 02903
    26 Research Site Sioux Falls South Dakota United States 57105
    27 Research Site Dallas Texas United States 75203
    28 Research Site Houston Texas United States 77030
    29 Research Site Houston Texas United States 77090
    30 Research Site Milwaukee Wisconsin United States 53295
    31 Research Site Ciudad Autónoma de Buenos Aires Argentina C1046
    32 Research Site New Lambton Heights Australia 2305
    33 Research Site South Brisbane Australia 4101
    34 Research Site Ottignies Belgium 1340
    35 Research Site Rio de Janeiro Brazil 21040-900
    36 Research Site Pernik Bulgaria 2300
    37 Research Site Pleven Bulgaria 5800
    38 Research Site Sofia Bulgaria 1000
    39 Research Site Sofia Bulgaria 1154
    40 Research Site Sofia Bulgaria 1606
    41 Research Site Varna Bulgaria 9010
    42 Research Site Calgary Alberta Canada T2N 1N4
    43 Research Site Montreal Quebec Canada H1T 2M4
    44 Research Site Quebec Canada G1V 4G5
    45 Research Site Bogota DC Colombia 111121
    46 Research Site Floridablanca Colombia 681004
    47 Research Site Medellin Colombia 050021
    48 Research Site Soledad Colombia 083001
    49 Research Site Villavicencio Colombia 500001
    50 Research Site Benesov Czechia 256 01
    51 Research Site Brno Czechia 625 00
    52 Research Site Kolin Czechia 280 02
    53 Research Site Kyjov Czechia 697 01
    54 Research Site Mlada Boleslav Czechia 293 01
    55 Research Site Praha 10 Czechia 100 34
    56 Research Site Praha 5 Czechia 150 30
    57 Research Site Aalborg Denmark 9000
    58 Research Site Copenhagen Ø Denmark 2100
    59 Research Site Hvidovre Denmark 2650
    60 Research Site Kolding Denmark 6000
    61 Research Site København Denmark 2400
    62 Research Site Vejle Denmark 7100
    63 Research Site Angers France 49033
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    65 Research Site Montpellier Cedex 5 France 34295
    66 Research Site Nantes Cedex 1 France 44800
    67 Research Site Orléans Cedex 2 France 45100
    68 Research Site Strasbourg Cedex France 67098
    69 Research Site Strasbourg France 67091
    70 Research Site Berlin Germany 10117
    71 Research Site Hannover Germany 30625
    72 Research Site Kiel Germany 24105
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    74 Research Site Leverkusen Germany 51375
    75 Research Site München Germany 81675
    76 Research Site Rostock Germany 18057
    77 Research Site Hong Kong Hong Kong
    78 Research Site Balassagyarmat Hungary 2660
    79 Research Site Budapest Hungary 1082
    80 Research Site Budapest Hungary 1121
    81 Research Site Győr Hungary 9024
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    83 Research Site Nyíregyháza Hungary 4400
    84 Research Site Pécs Hungary 7624
    85 Research Site Ahmedabad India 380054
    86 Research Site Ahmedabad India 382415
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    88 Research Site Chennai India 600113
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    94 Research Site Pune India 411030
    95 Research Site Thane India 401107
    96 Research Site Beer Sheva Israel 8410101
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    98 Research Site Petah Tikva Israel 4941492
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    100 Research Site Rehovot Israel 76100
    101 Research Site Arezzo Italy 52100
    102 Research Site Brescia Italy 25123
    103 Research Site Napoli Italy 80131
    104 Research Site Rozzano Italy 20089
    105 Research Site Torino Italy 10149
    106 Research Site Kasuga-shi Japan 816-0864
    107 Research Site Okazaki-shi Japan 444-0827
    108 Research Site Shinjuku-ku Japan 162-8655
    109 Research Site Suita-shi Japan 565-0871
    110 Research Site Daegu Korea, Republic of 42415
    111 Research Site Jeonju Korea, Republic of 54907
    112 Research Site Seoul Korea, Republic of 143-729
    113 Research Site Kuala Lumpur Malaysia 59100
    114 Research Site Kuantan Malaysia 25200
    115 Research Site Kubang Kerian Malaysia 16150
    116 Research Site Petaling Jaya Malaysia 47500
    117 Research Site Pulau Pinang Malaysia 10450
    118 Research Site Sarawak Miri Malaysia 98000
    119 Research Site Shah Alam Malaysia 40000
    120 Research Site Guadalajara Mexico 44340
    121 Research Site Monterrey Mexico 64460
    122 Research Site Tlalpan Mexico 14050
    123 Research Site Cusco Peru CUSCO 01
    124 Research Site el Agustino Peru LIMA 10
    125 Research Site Lima Peru 15088
    126 Research Site Lima Peru LIMA 01
    127 Research Site Lima Peru LIMA 1
    128 Research Site Lima Peru LIMA 31
    129 Research Site Piura Peru 05
    130 Research Site Cebu Philippines 6000
    131 Research Site Iloilo City Philippines
    132 Research Site Manila Philippines 1000
    133 Research Site Quezon City Philippines 1100
    134 Research Site Quezon City Philippines 1109
    135 Research Site Chrzanów Poland 32-500
    136 Research Site Rzeszów Poland 35-241
    137 Research Site Warszawa Poland 01-138
    138 Research Site Jeddah Saudi Arabia 21423
    139 Research Site Riyadh Saudi Arabia 11426
    140 Research Site Riyadh Saudi Arabia 12231
    141 Research Site Riyadh Saudi Arabia 12372
    142 Research Site Bratislava Slovakia 82606
    143 Research Site Košice Slovakia 04001
    144 Research Site Trnava Slovakia 91775
    145 Research Site Barcelona Spain 08036
    146 Research Site Madrid Spain 28034
    147 Research Site Malaga Spain 29010
    148 Research Site Palma de Mallorca Spain 07010
    149 Research Site Santander Spain 39008
    150 Research Site Lund Sweden 22185
    151 Research Site Stockholm Sweden 18288
    152 Research Site Umeå Sweden 90185
    153 Research Site Västerås Sweden 72189
    154 Research Site Kaohsiung Taiwan 80756
    155 Research Site Taichung Taiwan 40705
    156 Research Site Taipei Taiwan 0116
    157 Research Site Taipei Taiwan 10002
    158 Research Site Taipei Taiwan 112
    159 Research Site Taoyuan Taiwan 333
    160 Research Site Bangkok Thailand 10400
    161 Research Site Bangkok Thailand 10700
    162 Research Site Chiang Mai Thailand 50200
    163 Research Site Khon-Kaen Thailand 40002
    164 Research Site Ankara Turkey 06800
    165 Research Site Diyarbakir Turkey 21280
    166 Research Site Istambul Turkey 34899
    167 Research Site Istanbul Turkey 34069
    168 Research Site Izmir Turkey 35110
    169 Research Site Malatya Turkey 44280
    170 Research Site Bristol United Kingdom BS105NB
    171 Research Site Dundee United Kingdom DD1 9SY
    172 Research Site Hampshire United Kingdom SO16 6YD
    173 Research Site Leeds United Kingdom LS9 7TF
    174 Research Site Leicester United Kingdom LE3 9QP
    175 Research Site London United Kingdom W6 8RF
    176 Research Site Oxford United Kingdom OX3 9DU
    177 Research Site Prescot United Kingdom L35 5DR
    178 Research Site Tyne And Wear United Kingdom NE29 8NH
    179 Research Site Wythenshawe United Kingdom M23 9LT
    180 Research Site Hanoi Vietnam 100000

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT05624450
    Other Study ID Numbers:
    • D9185C00001
    • 2022-003107-15
    First Posted:
    Nov 22, 2022
    Last Update Posted:
    Feb 2, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    Acute Respiratory Failure
    Acute Respiratory Distress Syndrome
    Viral lung infection
    Tozorakimab
    Supplemental Oxygen
    IL-33
    COVID-19
    SARS-CoV-2
    Coronavirus Infections
    Virus Diseases
    SARS Coronavirus
    MEDI3506
    Respiratory Tract Infections
    Infections
    Lung Diseases
    Influenza
    Additional relevant MeSH terms:
    Infections
    Respiratory Insufficiency

    Study Results

    No Results Posted as of Feb 2, 2023