Study identifier:D9185C00001
ClinicalTrials.gov identifier:NCT05624450
EudraCT identifier:2022-003107-15
CTIS identifier:2023-507031-38-00
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
Viral lung infection and acute respiratory failure
Phase 3
No
Tozorakimab, Placebo
All
2870
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
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 to IMV/ECMO.
Location
Status
Location
Boise, ID, United States, 83702
Status
Recruiting
Location
Brooklyn, NY, United States, 11203
Status
Recruiting
Location
Benesov, Czech Republic, 256 01
Status
Recruiting
Location
Pulau Pinang, Malaysia, 10450
Status
Recruiting
Location
Diyarbakir, Turkey, 21280
Status
Recruiting
Location
Portland, OR, United States, 97239
Status
Withdrawn
Location
Leeds, United Kingdom, LS9 7TF
Status
Recruiting
Location
el Agustino, Peru, LIMA 10
Status
Withdrawn
Arms | Assigned Interventions |
---|---|
Experimental: Tozorakimab Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab. | Drug: Tozorakimab Single IV dose of tozorakimab on Day 1. Other Name: MEDI3506 |
Placebo Comparator: Placebo Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1435) will receive matching placebo. | Drug: Placebo Single IV dose of matching placebo on Day 1. |
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