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CTRI Number  CTRI/2023/09/058035 [Registered on: 26/09/2023] Trial Registered Prospectively
Last Modified On: 25/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA). 
Scientific Title of Study   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 (TILIA). 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
D9185C00001 Protocol V3.0 dated 22 Aug 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Mr Tapankumar M Shah 
Designation  Senior Director, Asia Area Cluster Head, Site Management & Monitoring  
Affiliation  AstraZeneca Pharma India Ltd. 
Address  Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road, Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  9535104975  
Fax    
Email  Tapankumar.Shah@astrazeneca.com  
 
Details of Contact Person
Public Query  
Name  Mr Tapankumar M Shah 
Designation  Senior Director, Asia Area Cluster Head, Site Management & Monitoring  
Affiliation  AstraZeneca Pharma India Ltd. 
Address  Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road, Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  9535104975  
Fax    
Email  Tapankumar.Shah@astrazeneca.com  
 
Source of Monetary or Material Support  
AstraZeneca AB 151 85 Sodertalje, Sweden 
 
Primary Sponsor  
Name  AstraZeneca Pharma India Ltd 
Address  Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, OuterRing Road, Bangalore – 560045, 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
AstraZeneca AB  151 85 Sodertalje, Sweden 
 
Countries of Recruitment     Argentina
Australia
Austria
Brazil
Bulgaria
Canada
Chile
China
Colombia
Czech Republic
Denmark
France
Germany
Hong Kong
Hungary
India
Israel
Italy
Japan
Malaysia
Mexico
Peru
Philippines
Poland
Republic of Korea
Romania
Saudi Arabia
Slovakia
South Africa
Spain
Sweden
Taiwan
Thailand
Turkey
United Kingdom
United States of America
Viet Nam  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Reshma Tewari  Artemis Hospital  Dept. of Critical Care Sector 51, Gurugram, PIN 122001
Gurgaon
HARYANA 		 9958402254

reshma@artemishospitals.com 
Dr Ajay Godse  Bhakti Vedanta Hospital and Research Institute  Dept. of Pulmonary Medicine, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road, Mira Bhayandar, PIN 401107
Mumbai
MAHARASHTRA 		 9820452037

drajaygodse@gmail.com 
Dr Shivakumar Iyer  Bharati Vidyapeeth (Deemed to be University)  Bharati Vidyapeeth Bhavan, Lal Bahadur Shastri Rd, Joshi Wada, Sadashiv Peth, Pune, Maharashtra 411030
Pune
MAHARASHTRA 		 9822051719

suchetashiva@gmail.com 
Dr Parthiv Mehta  Central United Hospital  Dept of Pulmonary Medicine Mangalam Arcade, Odhav Rd, Opposite Odhav Talav B.R.T.S Bus stop, G I D C Industrial Area, Odhav, Ahmedabad, PIN 382415
Ahmadabad
GUJARAT 		 7575004800

parthiv@cuhindia.com 
Dr Sudhir Prasad  Gleneagles Aware Hospitals  Nagarjuna Sagar Rd, Laxmi Enclave, Bhagya Nagar, Bairamalguda, Hyderabad, Telangana 500035
Hyderabad
TELANGANA 		 9704176506

drsudhirprasad@gmail.com 
Dr Jayprakash Appajigol  KLES Dr. Prabhakar Kore Hospital & Medical Research Center  Dept. of General Medicine, NH Service Road, Basava Circle, Chikodi, Nehru Nagar, Belagavi, PIN 590010
Belgaum
KARNATAKA 		 9844595659

jayaprakashappajigol@gmail.com 
Dr Nitesh Shah  Marengo CIMS Hospital  Dept of Pulmonary and Respiratory Medicine, Off Science City Road, Science City, Panchamrut Bunglows II, Sola, PIN 380060
Ahmadabad
GUJARAT 		 9825027487

dr.nitesh.shah@maregoasia.com 
Dr Arun Dewan  Max Smart Hospital  Max Smart Super Speciality Hospital, Saket (A unit of Gujarmal Modi Hospital and Research Centre for Medical Sciences) Mandir Marg, Press Enclave Road, Saket, New Delhi-110017
New Delhi
DELHI 		 9810091290

arun.dewan@maxhealthcare.com 
Dr Anand Jaiswal  Medanta - The medicity  Dept. of Respiratory & Sleep Medicine Medanta - The medicity, CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122001
Gurgaon
HARYANA 		 9818237391

anand.jaiswal@medanta.org 
Dr Atul Gogia  Sir Ganga Ram Hospital  Sir Ganga Ram Hospital Marg, Old Rajinder Nagar, New Rajinder Nagar, New Delhi, Delhi 110060
New Delhi
DELHI 		 9891003450

atulgogs@gmail.com 
Dr Rohit Kumar  VMMC & Safdarjung Hospital  Department of Pulmonary, Critical Care & Sleep Medicine, VMMC & Safdarjung Hospital NH 48, near AIIMS Hospital, Ansari Nagar West, New Delhi, Delhi 110029
New Delhi
DELHI 		 9911218081

dr.rohitkumar@mail.com 
Dr Poongulali Selvamuthu  Voluntary Health Services VHS Infectious Disease Medical Centre   Department of Infectious Disease SH 49A, Pallipattu, Tharamani, Chennai, PIN 600113
Chennai
TAMIL NADU 		 9940560019

poongulali@cartcrs.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Artemis Health Sciences Institutional Ethics Committee   Approved 
Bhaktivedanta Hospital Ethics Committee Bhaktivedanta Hospital and Research   Approved 
Ethics Committee Sir Gangaram Hospital  Approved 
Institutional ethics committee Care Institute of Medical Sciences   Approved 
Institutional Ethics Committee Gleneagles Global Hospitals  Approved 
Institutional ethics committee KLE University KLE Dr.PK Hospital and MRC  Approved 
Institutional Ethics Committee Bharati Vidyapeeth Deemed University  Approved 
Institutional ethics committee The Voluntary Health Services Multi speciality Hospital & Research Centre  Approved 
Institutional ethics committee VMMC & Safdarjung  Approved 
Max Health Care Ethics Committee   Approved 
Medanta Institutional Ethics Committee (MIEC)   Approved 
SHREY HOSPITAL INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J398||Other specified diseases of upperrespiratory tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Matching volume (2 mL) to Tozorakimub and single dose given at randomisation (1-time dose) 
Intervention  Tozorakimab  150 mg/mL, Single dose 300 mg (2 mL) given at randomisation (1-time dose), IV injection 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
Age
1. Adult participants ≥ 18 years old at the time of signing the ICF.
Type of Participant and Disease Characteristics
2. Patients hospitalised with viral lung infection. Note: Suspected viral aetiology is acceptable to meet this criterion.
3. Hypoxaemia requiring treatment with supplemental O2, consistent with WHO Clinical Progression Scale for Disease Progression score of 5 and 6.
Note: Hypoxemia is defined as SpO2 ≤ 94% on room air at screening, or documented SpO2 ≤ 94% prior to initiation of oxygen therapy. Patients receiving oxygen > 6 L/min or non-invasive ventilation will be considered to have met this inclusion criterion regardless of SpO2 levels.
4. ≤ 36 hours since admission to hospital.
5. ≤ 14 days since onset of respiratory viral infection symptoms.
 
 
ExclusionCriteria 
Details  Medical Conditions
1 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 participants condition.
2 Hypoxaemia caused primarily by extrapulmonary insult (eg, multiorgan failure, shock, or sepsis) or by lung injury of non infective aetiology (eg, trauma, chemical injury, etc).
3 Ongoing or impending IMV/ECMO at randomisation (ie, WHO Clinical Progression Scale score ≥ 7).
4 Any comorbid condition that, in the opinion of the investigator, is likely to result in death within 3 months from randomisation.
5 Anticipated recovery and discharge from the hospital within 24 hours of randomisation.
6 Active tuberculosis defined as requiring current treatment.
7 Known unstable cardiovascular disease (eg, unstable chronic heart failure NYHA III-IV, recent myocardial infarction or stroke within 3 months, or uncontrolled ventricular arrythmia) that in the investigator s judgement may put the participant at risk or negatively affect the outcome of the study.
8 Known absolute neutrophil count ≤ 1.0 x 109/L.
9 Untreated HIV. Known history of active hepatitis B or C (treated and controlled hepatitis is allowed).
10 Known history of active severe inflammatory bowel disease or colitis (including Crohn disease or ulcerative colitis).
11 Malignancy, current or within the past 5 years, except for adequately treated non invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment.
12 Any disorder that is not stable in the opinion of the investigator, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious (including risk factors for viral lung infection), endocrine, metabolic, haematological, immune, psychiatric, or major physical impairment and could:
a. affect the safety of the participant throughout the study,
b. influence the findings of the study or their interpretation,
c. impede the participant s ability to complete the entire duration of the study.

Prior/Concomitant Therapy
13 Use of long-term oxygen therapy for pre-existing conditions.
14 Chronic treatment with TNF inhibitors, Janus kinase inhibitors or interferon gamma. Wash-out period of 4 weeks or 5 half-lives (whichever is longer) is required prior to enrolment.
15 Current treatment with any investigational medication. Wash-out period of 4 weeks or 5 half-lives (whichever is longer) is required prior to prior to enrolment.
16 Participants who have previously received tozorakimab.
17 Known history of:
a. anaphylaxis to any other biologic therapy,
b. severe reaction to any medication including biologic agents or human gamma globulin therapy,
c. allergy or reaction to any component of the study intervention formulation.

Contraception
18 Pregnant and lactating participants.
19 Male participants who are sexually active with a FOCBP and participants that are FOCBP who are sexually active with a male partner, unless they agree to use highly effective contraceptive methods from enrolment throughout the study and until at least 14 weeks after last dose of IP.

Other Exclusions
20 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
Inability of the participant to understand and/or comply with study procedures and/or attend all telephone calls and follow-up visit in the opinion of the investigator.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of tozorakimab versus placebo as add on to SoC in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO by Day 60  Proportion of participants who die or
progress to IMV/ECMO by Day 60 (WHO CPS score ≥ 7) 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of tozorakimab versus placebo as add-on to SoC on all-cause mortality by Day 60  Proportion of participants who die by Day 60 
To evaluate the effect of tozorakimab versus placebo as add-on to SoC on ICU stay  Number of days alive and outside of ICU over 60 day period 
To evaluate the effect of tozorakimab versus placebo as add-on to SoC on the duration of oxygen supplementation  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 SoC on prolonging time to death or IMV/ECMO  Time to death or progression to IMV/ECMO
Proportion of participants who die or progress to IMV/ECMO by Day 28
 
To evaluate the effect of tozorakimab versus placebo as add-on to SoC on prolonging time to death  Time to death (all cause)
Proportion of participants who die by Day 28
 
To evaluate the effect of tozorakimab versus placebo as add-on to SoC on ventilator use   Number of days alive and free of IMV/ECMO (WHO CPS score 7) over 60 day period
Number of days alive and ventilator free (WHO CPS score 6) over 60 day period 
To evaluate the effect of tozorakimab versus placebo as add-on to SoC on ICU admissions  Proportion of participants with ICU admission or death by Day 60
Proportion of participants with ICU admission or death by Day 28
 
To evaluate the effect of tozorakimab versus placebo as add-on to SoC on duration of hospitalisation  Proportion of participants alive and discharged by Day 28
Proportion of participants alive and discharged by Day 60
Time to discharge (time to WHO CPS score ≤ 3)
Time to being off supplemental oxygen (time to WHO CPS score ≤ 4)
 
To evaluate the effect of tozorakimab as add-on to SoC on clinical status as assessed by the Investigator using WHO 10-category ordinal Clinical Progression Scale by Day 60  WHO Clinical Progression Scale rank-based comparison - 60 Days 
To evaluate the PK and immunogenicity of tozorakimab in participants with viral lung infection requiring supplemental oxygen  PK: Serum tozorakimab concentrations
Immunogenicity: Incidence of ADA - 60 Days
 
To evaluate the use of baseline IL-33/sST2 levels to predict treatment response with tozorakimab versus placebo as add on to SoC  Baseline serum IL-33/sST2 relative to primary endpoint - 60 Days 
 
Target Sample Size   Total Sample Size="2352"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 24/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/11/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is 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.

The primary outcome is the proportion of participants who die or progress to invasive mechanical ventilation (IMV) / extracorporeal membrane oxygenation (ECMO) by Day 60 (WHO clinical progression scale score ≥ 7). Study intervention will be administered on Day 1. The participants status will be recorded daily while in hospital. Upon discharge, the participant will be followed up by phone on Day 14 and Day 28. Final on-site visit will be performed on Day 60.

 

The study initially plans to randomise up to approximately 2352 participants (ie, 1176 per treatment arm), although the final sample size will be determined by when the required number of events are observed. Recruitment will continue until approximately 375 primary endpoint events are expected for the primary population or until after an interim analysis has triggered an early stop. Randomisation will be stratified by known viral positivity at randomisation (SARS‑CoV‑2 versus other virus versus indeterminate), and region.

Participants will be randomised in a 1:1 ratio to receive a single IV injection of tozorakimab 300 mg or matching IV injection of placebo within 36 hours from the admission to hospital.

The study intervention will be administered in addition to standard of care (SoC) treatments. Study participants will continue receiving SoC based on local guidelines throughout the study.

To evaluate the effect of tozorakimab versus placebo as add on to SoC in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO by Day 60. 
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