Eligibility

Local study conflicts

Inclusion Criteria:

  1. Age 18 years old or above and:

    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;
    Hypoxaemia is defined as either
    1. SpO2 ≤ 90%
      OR
    2. SpO2 ≤ 92% AND one or both of the following:
      • Radiographic infiltrates by Chest X-ray/CT scan compatible with viral lung infection per investigator judgement.
      • Use of accessory muscles of respiration or respiratory rate > 22/minute.

        Note: Patients receiving oxygen > 6 L/min or non-invasive ventilation will be considered to have met this inclusion criterion regardless of SpO2 levels.
        Patients receiving oxygen 3-6L/min will be considered to have met this inclusion criterion if their SpO2 level is ≤96%.
        A documented pre-hospital SpO2 (related to the episode) is acceptable, eg, from the ambulance report.

    4. And both of:

  4. ≤ 36 hours since admission to hospital. (Refer to Section 4.1.2 for more details.)
  5. ≤ 14 days since onset of respiratory viral infection symptoms.

    6. And additional criteria that must be met:

  6. Patient remains hypoxaemic at time of randomisation, requiring treatment with supplemental oxygen. One of the following must apply:
    • Requiring oxygen > 6 L/min or non-invasive ventilation regardless of SpO2 levels
      OR
    • SpO2 ≤ 96% while receiving oxygen 3-6 L/min
      OR
    • SpO2 ≤ 92% while receiving oxygen < 3 L/min (including room air)

Exclusion Criteria:

Medical conditions
  1. Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or evidence of septic shock. Bacterial co-infection is allowed, unless, in the opinion of the investigator, bacterial infection defines the severity of the participant’s condition (see Appendix J).
  2. Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of noninfective aetiology (eg, trauma, chemical injury, etc).
  3. Ongoing IMV/ECMO at randomisation.
  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 disease requiring current treatment.
  7. Known unstable cardiovascular disease (eg, chronic heart failure NYHA Class IV, recent myocardial infarction or stroke within 3 months, uncontrolled ventricular arrhythmia, or cardiogenic pulmonary oedema, which is driving the severity of the hypoxaemia, 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. Known untreated HIV. Known history of active hepatitis B or C (treated and controlled hepatitis and HIV are allowed).
  10. Known history of active severe inflammatory bowel disease or colitis (including Crohn’s disease or ulcerative colitis).
  11. The following malignancies:
    • Solid tumours with metastases (Stage IV)
    • Lymphoma/leukaemia not in complete remission
    • Malignancies treated with chemotherapy and/or immunomodulatory drugs within the past 2 months
  12. Transplant patients at risk of organ rejection, or those on long-term immunosuppressive treatment for the transplant. Treatment with corticosteroids is allowed.
  13. 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:
    • affect the safety of the participant throughout the study
    • influence the findings of the study or their interpretation
    • impede the participant’s ability to complete the entire duration of the study
Prior/Concomitant Therapy
  1. Use of long-term oxygen therapy for pre-existing conditions.
  2. 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.)
  3. Current treatment with any investigational medication. Wash-out period of 4 weeks or 5 half-lives (whichever is longer) is required prior to enrolment.
  4. Participants who have previously received tozorakimab.
  5. Known history of:
    • anaphylaxis to any biologic therapy
    • severe reaction to any medication, including biologic agents or human gamma globulin therapy

If the patient is eligible:

Inform the patient that they may be eligible for the TILIA-A study.

Gain verbal agreement in principle before proceeding further. Explain:



Step-by-Step Guide to Recruitment:

In the working hours of the research team:




Links for further information:

Link to trial site