COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002913-16/PL

Boehringer Ingelheim Pharma GmbH & Co. KG - CT Disclosure & Data Transparency

clintriage.rdg@boehringer-ingelheim.com

2021-12-20

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Age ≥ 18 years (or above legal age) 2. ARDS with PaO2*/FiO2 ratio >100 and ≤300 , either on non-invasive ventilator support, OR on mechanical ventilation (<48 hours since intubation), with bilateral opacities in chest X-ray or CT scan (not fully explained by effusions, lobar/lung collapse, or nodules) with respiratory failure (not fully explained by cardiac failure/fluid overload) *or estimation of PaO2/FiO2 from pulse oximetry (SpO2/FiO2) 3. SARS-CoV-2 positive (laboratory-confirmed RT-PCR test) 4. Fibrinogen level ≥ lower limit of normal 5. D-Dimer ≥ upper limit of normal (ULN) according to local laboratory 6. Signed and dated written informed consent in accordance with ICH Good Clinical Practice (GCP) and local legislation prior to admission to the trial.

1. Massive confirmed PE with haemodynamic instability at trial entry, or any (suspected or confirmed) PE that is expected to require therapeutic dosages of anticoagulants during the treatment period 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 FEV1 <50%, requiring home oxygen, or oral steroid therapy or hospitalisation for exacerbation within 12 months, or significant chronic pulmonary disease in the Investigator’s opinion, or primary pulmonary arterial hypertension 5. Has a Do-Not-Intubate (DNI) or Do-Not-Resuscitate (DNR) order 6. In the opinion of the investigator not expected to survive for > 48 hours after screening. 7. Planned interventions during the first 5 days after randomization, such as surgery, insertion of central catheter or arterial line, drains, etc. 8. Known hypersensitivity to the active substance alteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients 9. Significant bleeding disorder at present or within the past 6 months, known haemorrhagic diathesis 10. Patients receiving effective oral anticoagulant treatment, e.g. vitamin K antagonists with INR >1.3, or any direct oral anticoagulant within the past 48 hours 11. Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) 12. History or evidence or suspicion of intracranial haemorrhage including sub-arachnoid haemorrhage 13. Severe uncontrolled arterial hypertension (according to the investigator`s judgement) 14. Major surgery or significant trauma in the past 10 days, recent trauma to head or cranium 15. Cardiac arrest and/or cardiopulmonary resuscitation during the current hospital stay 16. Obstetrical delivery within the past 10 days 17. Severe hepatic dysfunction i.e. Child-Pugh B and C, including biopsy confirmed hepatic cirrhosis, portal hypertension, hepatic encephalopathy, or active hepatitis 18. Bacterial endocarditis, pericarditis 19. Acute pancreatitis 20. Documented ulcerative gastro-intestinal disease during the last 3 months 21. Severe heart failure (New York Heart Association Class IV) 22. Arterial aneurysms, arterial/venous malformations 23. Malignancy (Stage IV) with increased bleeding risk Further criteria apply.

2

Boehringer Ingelheim RCV GmbH & Co KG

18

100

Argentina;Australia;Austria;Belgium;Brazil;Colombia;Denmark;Egypt;France;Germany;India;Italy;Mexico;Netherlands;Poland;Portugal;Romania;Russia;South Africa;Spain;Tunisia;Turkey

Severe disease at enrollment

6: Severe disease at enrollment

20

1) Time to clinical improvement or hospital discharge up to Day 28, defined as the time from randomization to either an improvement of two points on the 11-point WHO Clinical Progression Scale or discharge from the hospital, whichever comes first.

Declared number of arm (2.0) differs from found arms (1.0)

Phase 2/Phase 3

[{"arm_notes": "New Type treatment : ALTEPLASE", "treatment_id": 71, "treatment_name": "Alteplase", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]