Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA).

Phase 1

• Conditions: Severe viral lung infections; MedDRA version: 21.1Level: PTClassification code 10001053Term: Acute respiratory failureSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2022-003107-15-IT
• Lead Sponsor: ASTRAZENECA AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-02
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2352

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
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 1176
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1176

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 or impending IMV/ECMO at randomisation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified