Phase 3
N=104
A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19
Acute Respiratory Distress Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04640194 ↗Enrolled (actual)
104
Serious AEs
50.0%
Results posted
Mar 2024
Primary outcome: Primary: Time to Clinical Improvement or Hospital Discharge up to Day 28 — NA; 19.0; NA; 22.0 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Standard of care (Procedure); Alteplase low dose (Drug); Alteplase high dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Clinical Improvement or Hospital Discharge up to Day 28 |
NA; 19.0; NA; 22.0; NA; 25.5 | — |
| SECONDARY Number of Subjects With Major Bleeding Events (MBE) at Day 6 |
1; 4; 0; 2; 0; 2 | — |
| SECONDARY All Cause Mortality at Day 28 |
2; 3; 6; 1; 2; 2 | 0.2419 |
| SECONDARY Number of Subjects With Treatment Failure at Day 28 |
8; 8; 11; 6; 3; 5 | 0.2523 |
| SECONDARY Number of Ventilator-free Days at Day 28 |
10.6; 11.8; 7.5 | — |
| SECONDARY Number of Subjects With Improvement of Sequential (Sepsis-related) Organ Failure Assessment (SOFA) Score by ≥2 Points at Day 6 |
4; 2; 6 | — |
| SECONDARY Daily Average PaO2/FiO2 Ratio Change From Baseline to Day 6 |
32.2; 58.5; 7.5 | — |
| SECONDARY Number of Oxygen-free Days up to Day 28 |
7.0; 4.5; 0.0; 0.0 | — |
| SECONDARY Length of Hospital Stay up to Day 28 |
28.0; 24.0; 28.0; 28.0 | 0.9856 |
| SECONDARY Worst PaO2/FiO2 Ratio Change From Baseline to Day 6 |
70.8; 0.0; -10.9; 3.4 | 0.0603 |
Summary
This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study. The purpose of the study is to find out whether a medicine called alteplase helps people get better faster.
The study has 2 parts. In the first part, participants are put into 3 groups by chance. Participants in 2 of the groups get 2 different doses of alteplase, in addition to standard treatment.
Participants in the third group get standard treatment. In the second part of the study, participants are put into 2 groups by chance. One group gets alteplase and standard treatment. The other group gets only standard treatment. Alteplase is given as an infusion into a vein. In both study parts, treatments are given for 5 days. Doctors monitor patients and check whether their breathing problems improve. They compare results between the groups after 1 month.
Participants are in the study for 3 months.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years (or above legal age, e.g. UK ≥16 years)
- ARDS with PaO2*/FiO2 ratio >100 and ≤300, either on non-invasive ventilator support, OR on mechanical ventilation ( 48 hours after admission
- Planned interventions during the first 5 days after randomisation, such as surgery, insertion of central catheter or arterial line, drains, etc.
- Patients with known hypersensitivity to the active substance alteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients
- Significant bleeding disorder at present or within the past 3 months, known haemorrhagic diathesis
- Patients receiving effective oral anticoagulant treatment, e.g. vitamin K antagonists with International normalised ratio (INR) >1.3, or any direct oral anticoagulant within the past 48 hours Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT04640194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.