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Aralast NP in Hospitalized COVID-19 Pneumonia
NCT04675086Phase 3
Key facts
- Status
- Withdrawn
- Start
- Jan 2021
- Primary completion
- Sep 2021
- Countries
- 1
- Sponsor
- Blessing Corporate Services, Inc.
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- COVID-19 pneumonia
01
Overview
Phase 3, randomised, open-label trial of alpha1-proteinase inhibitor in COVID-19 pneumonia (2 arms), sponsored by Blessing Corporate Services, Inc. Primary endpoint: Duration of new non-invasive ventilation or high flow oxygen use at 365 Days. Planned start Jan 2021; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedOpen-label
Aralast NP + Antiviral + SOC
Aralast NP infusions on Days 1, 3, 5, 7, 9, 17 + Remdesivir + SOC
Antiviral + SOC
Remdesivir + SOC
03
Who it enrols
Hospitalized adults with lab-confirmed COVID-19 and pneumonia on supplemental oxygen/NIV with PO2/FiO2 < 300 and elevated inflammatory markers. Excludes patients on mechanical ventilation at screening, those with A1AT deficiency, or those receiving other investigational drugs.
04
Endpoints
Primary
Duration of new non-invasive ventilation or high flow oxygen use
Secondary
Clinical status on a 7-point ordinal scale
Percentage change in cytokine levels
Percentage change in oxygen requirements including PEEP and FiO2
Percentage of subjects that required mechanical ventilation
Percent of patients with a SOFA score between 0-6
Percent of mortality
Need, dosage and duration of vasopressors
Number of Days fever free
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