Status:

RECRUITING

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

Lead Sponsor:

AstraZeneca

Conditions:

Viral Lung Infection and Acute Respiratory Failure

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression t...

Eligibility Criteria

Inclusion Criteria:

  • Adult participants ≥ 18 years old 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

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 (respiratory rate) > 22.

- Patient remains hypoxaemic at randomisation requiring treatment with supplemental oxygen.

Exclusion Criteria:

  • Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or evidence of septic shock. 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.

Key Trial Info

Start Date :

December 13 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 19 2026

Estimated Enrollment :

2870 Patients enrolled

Trial Details

Trial ID

NCT05624450

Start Date

December 13 2022

End Date

June 19 2026

Last Update

November 17 2025

Active Locations (451)

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Page 1 of 113 (451 locations)

1

Research Site

Mobile, Alabama, United States, 36608

2

Research Site

Phoenix, Arizona, United States, 85008

3

Research Site

Phoenix, Arizona, United States, 85013

4

Research Site

Tucson, Arizona, United States, 85719