JPRN-jRCT2041220138
Recruiting
Phase 3
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
Ageishi Yuji0 sites2,902 target enrollmentFebruary 8, 2023
ConditionsViral Lung Infection
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Viral Lung Infection
- Sponsor
- Ageishi Yuji
- Enrollment
- 2902
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult participants 18 years old or more 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 less OR
- •\- SpO2 92% or less AND one or both of the following:
- •o Radiographic infiltrates by Chest X\-ray/CT scan compatible with viral lung infection per investigator judgement.
- •o Use of accessory muscles of respiration or respiratory rate over 22/minute.
Exclusion Criteria
- •\- 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.
- •\- Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non\-infective aetiology.
- •\- Ongoing IMV/ECMO at randomisation.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 3
Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease with a History of ExacerbationsCOPDJPRN-jRCT2041230113Ageishi Yuji55
Active, not recruiting
Phase 1
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA).EUCTR2022-003107-15-BGAstraZeneca AB2,902
Active, not recruiting
Phase 1
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA).EUCTR2022-003107-15-SKAstraZeneca AB2,902
Recruiting
Phase 3
Efficacy and Safety of MEDI3506 in Symptomatic Chronic Obstructive Pulmonary Disease with a History of ExacerbationsCTRI/2022/03/040954AstraZeneca AB
Active, not recruiting
Phase 1
Study to assess efficacy, safety, and tolerability of MEDI3506 in symptomatic chronic obstructive pulmonary disease (COPD) with a history of exacerbations.Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 21.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2021-003771-34-FRAstraZeneca AB1,272