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Alteplase in COVID-19 ARDS
NCT04640194Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2020
- Primary completion
- Jul 2022
- Countries
- 13
- Sponsor
- Boehringer Ingelheim
- Modality
- rProtein (Recombinant Protein), Biologic
- Drugs
- alteplase
- Conditions
- acute respiratory distress syndrome (ARDS)coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, open-label trial of alteplase in acute respiratory distress syndrome (ARDS) and coronavirus disease 2019 (COVID-19) (7 arms), sponsored by Boehringer Ingelheim. Primary endpoint: Time to Clinical Improvement or Hospital Discharge at 28 days. Started Dec 2020; status: completed.
02
Design
7 arms- Study design
- RandomizedOpen-label
Part 1: Low Dose
Alteplase 0.3 mg/kg load + 0.02 mg/kg/h for 5 days + SOC
Part 1: High Dose
Alteplase 0.6 mg/kg load + 0.04 mg/kg/h for 5 days + SOC
Part 1: SOC
Standard of Care alone
Part 2: High Dose (NIV)
Alteplase High Dose + SOC (NIV stratum)
Part 2: SOC (NIV)
Standard of Care alone (NIV stratum)
Part 2: High Dose (IMV)
Alteplase High Dose + SOC (IMV stratum)
1 more in the full profile.
03
Who it enrols
Adult patients with COVID-19 related ARDS (PaO2/FiO2 100-300), on NIV or mechanical ventilation <48h, with elevated D-dimer and normal fibrinogen.
04
Endpoints
Primary
Time to Clinical Improvement or Hospital Discharge
Secondary
Number of Subjects With Major Bleeding Events (MBE)
All Cause Mortality at Day 28
Number of Subjects With Treatment Failure
Number of Ventilator-free Days
Number of Subjects With Improvement of SOFA Score by >=2 Points
Daily Average PaO2/FiO2 Ratio Change From Baseline
Number of Oxygen-free Days
Length of Hospital Stay
05
Results
Not all primary endpoints met
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