Infectious Disease Clinical Trials
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA)
Learn moreWhat is the purpose of this study?
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.
Eligibility
- Adult participants ≥ 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 ≤ 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.
- Patient remains hypoxaemic at randomisation requiring treatment with supplemental oxygen.
- 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.
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
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
- Disease Type/ConditionViral Lung Infection and Acute Respiratory Failure
- Principal InvestigatorPhilip A. Robinson, MD
- Co-InvestigatorsGrace M. Lozinski, MD, Philip Robinson, MD
- Age GroupAdult, Older Adult
- PhaseIII
- ClinicalTrials.gov IDNCT05624450
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org
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