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-BG
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-30
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2902

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.

Study & Design

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