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JXR MEDI ASHB TILIA

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study 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 (TILIA)
Protocol number OCR43584
ClinicalTrials.gov ID NCT05624450
Phase Phase 3

Eligibility

Inclusion Criteria:

  • Adult participants 鈮� 18 years old at the time of signing the informed consent form.

  • Patients hospitalised with viral lung infection.

  • Hypoxaemia requiring treatment with supplemental O2.

Hypoxaemia is defined as:

SpO2 鈮� 90% OR

SpO2 鈮� 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.

  • Patient remains hypoxaemic at randomisation requiring treatment with supplemental oxygen.

Exclusion Criteria:

  • 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.

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

  • Ongoing IMV/ECMO at randomisation.

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.