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Clazakizumab in Life-threatening COVID-19
NCT04343989Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2020
- Primary completion
- Feb 2021
- Countries
- 1
- Sponsor
- NYU Langone Health
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- clazakizumab
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 2, randomised, double-blind trial of clazakizumab in coronavirus disease 2019 (COVID-19) (3 arms), sponsored by NYU Langone Health. Primary endpoints: Ventilator Free Survival at 28 days and Number of Serious Adverse Events Associated With High and Low Dose of Clazakizumab at 60 days. Started Mar 2020; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Clazakizumab 25 mg
Clazakizumab 25 mg IV
Clazakizumab 12.5 mg
Clazakizumab 12.5 mg IV (Dropped in Phase III)
Placebo
Placebo IV
03
Endpoints
Primary
Ventilator Free Survival
Number of Serious Adverse Events Associated With High and Low Dose of Clazakizumab
Secondary
Overall Patient Survival
Number of Participants With Change in Clinical Status
Number of Clazakizumab-expected Adverse Events
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