EUCTR2022-003107-15-BG
Active, not recruiting
Phase 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).
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AstraZeneca AB
- Enrollment
- 2902
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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