What side effects are associated with this type of intervention?

Common treatments for viral pneumonia, particularly those involving monoclonal antibodies like Tozorakimab, often aim to reduce inflammation. Known side effects of these treatments can include infusion-related reactions (such as fever, chills, and rash), increased risk of infections, and potential hypersensitivity reactions. Other side effects may include fatigue, headache, and gastrointestinal issues like nausea and diarrhea. It is important to monitor patients for these adverse effects and manage them appropriately.

What prior FDA approvals exist?

The FDA has approved several treatments for viral pneumonia, particularly in the context of COVID-19. Monoclonal antibodies such as tocilizumab and sarilumab, which target the IL-6 receptor to reduce inflammation, have been used to treat severe cases of COVID-19 pneumonia. These treatments are similar to Tozorakimab, which targets IL-33 to reduce inflammation. Additionally, antiviral drugs like remdesivir have been approved to reduce the severity and duration of viral pneumonia caused by COVID-19.

What other types of research exist?

Promising alternatives to Tozorakimab for viral pneumonia patients in 2024 may include Tofacitinib, a Janus kinase inhibitor, which has shown efficacy in treating inflammatory lung conditions. Other monoclonal antibodies targeting different inflammatory pathways could also be considered.

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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 28 day and 60 day period

Awards & highlights

Pivotal Trial

Summary

This trial is testing tozorakimab, a medication that may help people with severe viral lung infections who need extra oxygen. The goal is to see if it can prevent death or the need for advanced breathing support. Tozorakimab works by reducing harmful inflammation in the lungs.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My low oxygen levels are due to a non-infectious lung injury or an external cause.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

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

Number of days alive and free of supplemental oxygen

+12 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TozorakimabExperimental Treatment1 Intervention

Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab.

Group II: PlaceboPlacebo Group1 Intervention

Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1435) will receive matching placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tozorakimab

2024

Completed Phase 1

~50

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for viral pneumonia often include antiviral medications, supportive care, and in some cases, monoclonal antibodies. Monoclonal antibodies, like Tozorakimab, target specific components of the immune response to reduce inflammation. Tozorakimab targets IL-33, a cytokine involved in the inflammatory process, thereby potentially reducing lung inflammation and preventing progression to severe respiratory failure. This is crucial for viral pneumonia patients as excessive inflammation can lead to complications such as acute respiratory distress syndrome (ARDS), prolonged hospitalization, and increased mortality. By modulating the immune response, monoclonal antibodies can help manage symptoms and improve outcomes in viral pneumonia.

Association between tocilizumab, sarilumab and all-cause mortality at 28 days in hospitalised patients with COVID-19: A network meta-analysis.Mycobacterium abscessus complex: A Review of Recent Developments in an Emerging Pathogen.Acalabrutinib monotherapy in patients with Waldenström macroglobulinemia: a single-arm, multicentre, phase 2 study.