EUCTR2022-003107-15-BGActive, not recruitingPhase 1
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).
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 2,902
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Adult participants = 18 years old at the time of signing the informed consent form.
- •2. Patients hospitalised with viral lung infection.
- •3. 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 > 22.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1451
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1451
Exclusion Criteria
- •1. Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or pulmonary sepsis. Bacterial co-infection is allowed, unless, in the opinion of the investigator, bacterial infection defines the severity of the participant’s condition.
- •2. Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology.
- •3. Ongoing IMV/ECMO at randomisation.
- •4. 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.
Investigators
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