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Tozorakimab for Viral Pneumonia (TILIA Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Hypoxaemia requiring treatment with supplemental O2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 28 day and 60 day period

Awards & highlights

TILIA Trial Summary

This trial tests a new drug to see if it prevents death or mechanical ventilation in patients with severe lung infection.

Who is the study for?

This trial is for adults over 18 hospitalized with a viral lung infection needing extra oxygen but not on mechanical ventilation or ECMO. They must have low blood oxygen levels and signs of the infection on chest scans, use extra muscles to breathe, or have a high respiratory rate.Check my eligibility

What is being tested?

The study tests Tozorakimab's effectiveness when added to standard care in preventing death or the need for intensive breathing support (IMV/ECMO) in patients with severe viral lung infections requiring supplemental oxygen.See study design

What are the potential side effects?

While specific side effects of Tozorakimab are not listed here, similar medications can cause reactions at the injection site, fever, fatigue, headaches, and potential impacts on immune response.

TILIA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have low oxygen levels and signs of a lung infection or difficulty breathing.

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I need extra oxygen to help me breathe.

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I am 18 years or older.

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I am in the hospital due to a lung infection caused by a virus.

TILIA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 28 day and 60 day period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over 28 day and 60 day period

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 28 day and 60 day period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Baseline serum interleukin-33/soluble Suppression of Tumorgenicity 2 (IL-33/sST2) complex levels relative to primary endpoint

Incidence of anti-drug antibodies

Number of days alive and free of Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)

+12 more

TILIA Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TozorakimabExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

0 / 4Eligibility criteria met

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Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,609,794 Total Patients Enrolled

Media Library

Tozorakimab Clinical Trial Eligibility Overview. Trial Name: NCT05624450 — Phase 3

Tozorakimab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05624450 — Phase 3

Viral Pneumonia Research Study Groups: Tozorakimab, Placebo

Viral Pneumonia Clinical Trial 2023: Tozorakimab Highlights & Side Effects. Trial Name: NCT05624450 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met for a person to enroll in this trial?

"This research protocol calls for 2352 participants who are between 18 and 65 years of age and have acute respiratory failure."

Answered by AI

Is the age range for this trial limited to younger participants or can persons over 35 years of age also participate?

"As stipulated by the study's inclusion criteria, only individuals aged 18 and older are eligible to participate. The upper age limit is also set at 18 years old."

Answered by AI

What are the safety risks associated with Tozorakimab usage?

"Tozorakimab has been demonstrated to be a safe drug, earning it a score of 3 due to the presence of clinical evidence both supporting its efficacy and safety."

Answered by AI

What is the geographical scope of this experiment?

"Currently, 29 different medical centres are enrolling for this study. These sites span from Newport Beach to Torrance and Washington D.C., among other locations. Choosing the closest clinic is advised in order to reduce travel needs if you decide to partake in the trial."

Answered by AI

Are there any active openings for prospective participants in this trial?

"Affirmative. According to the clinicaltrials.gov website, this study is presently seeking applicants; it was initially posted on December 13th 2022 and has had a recent update on December 19th 2022. In total, 29 sites need to recruit 2352 participants for the trial."

Answered by AI

What is the total number of participants engaged in this experiment?

"Affirmative, clinicaltrials.gov attests to this experimental study's active recruitment process. First posted on December 13th 2022 and last updated December 19th 2022, the trial seeks 2352 participants from 29 sites across the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05624450.

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