Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Alteplase plus SOC: Initial i.v. infusion of alteplase 0.6 mg per kg over 2 hours (Day 1) immediately followed by daily i.v. infusion of 0.04 mg per kg per hour over 12 hours (starting
Sponsors
Boehringer Ingelheim International GmbH
PAREXEL International Clinical Research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients participating in Part 1 are not eligible for Part 2 2) Age greater than equal to 18 years (or above legal age) 3) ARDS with PaO2/FiO2 ratio greater than 100 and less than or equal to 300, either on noninvasive ventilator support, OR on mechanical ventilation (less than 48 hours since intubation) 3a) With bilateral opacities in chest X-ray or CT scan (not fully explained by effusions, lobar/lung collapse, or nodules) 3b) With respiratory failure (not fully explained by cardiac failure/fluid overload) or estimation of PaO2/FiO2 from pulse oximetry (SpO2/FiO2) 4) SARS-CoV-2 positive (laboratory-confirmed RT-PCR test) 5) Fibrinogen level � upper limit of normal 6) D-Dimer greater than equal to 3-fold of upper limit of normal (ULN) according to local laboratory 7) Signed and dated written informed consent in accordance with ICH Good Clinical Practice (GCP) and local legislation prior to admission to the trial
Exclusion criteria
Exclusion criteria: 1 Massive confirmed pulmonary embolism (PE) with haemodynamic instability at trial entry 2 Indication for therapeutic dosages of anticoagulants at trial entry 3 Mechanical ventilation for longer than 48 hours 4 Chronic pulmonary disease i.e. with known forced expiratory volume in 1 second (FEV1) 5 Has a Do-Not-Intubate (DNI) or Do-Not-Resuscitate (DNR) order 6 In the opinion of the investigator, is not expected to survive for > 48 hours after screening. 7 Planned interventions during the first 5 days after randomisation, such as surgery, insertion of central catheter or arterial line, drains, etc 8 Further criteria apply to exclude patients at higher risk of bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to clinical improvement or hospital discharge Time from randomisation to either an improvement of two points on the 11-point WHO Clinical Progression Scale or discharge from the hospital, whichever comes first. The WHO Clinical Progression Scale ranges from 0 to 10. A higher score indicates a worsening of the patient statusTimepoint: Up to day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause mortalityTimepoint: At Day 28;Length of hospital stayTimepoint: Up to Day 28;Major bleeding events (MBE)Timepoint: Up to Day 6;Number of oxygen-free daysTimepoint: Up to Day 28;PaO2/FiO2 ratio (or inferred PaO2/FiO2 ratio from SpO2) change PaO2: partial oxygen pressure in arterial blood FiO2: fraction of inspired oxygen SpO2: Oxygen saturationTimepoint: From baseline to end of Day 6;Treatment failureTimepoint: At Day 28 | — |
Countries
Argentina, Austria, Belgium, Brazil, Denmark, France, Germany, India, Italy, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Tunisia, Turkey, Ukraine
Contacts
Public ContactDr Annappa Kamath
PAREXEL International Clinical Research Private Limited
Outcome results
None listed