The TRISTARDS trial - ThRombolysIS Therapy for ARDS A study to test whether different doses of alteplase help people with severe breathing problems because of COVID 19.

The TRISTARDS trial - ThRombolysIS Therapy for ARDS A Phase IIb/III operationally seamless, open-label, randomised, sequential, parallel-group adaptive study to evaluate the efficacy and safety of daily intravenous alteplase treatment given up to 5 days on top of standard of care (SOC) compared with SOC alone, in patients with acute respiratory distress syndrome (ARDS) triggered by COVID-19.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002913-16-PT

Enrollment

270

Registered

2020-11-13

Start date

2020-12-17

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory distress syndrome caused by Covid-19 MedDRA version: 21.1 Level: PT Classification code 10001052 Term: Acute respiratory distress syndrome System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Alteplase Powder and Solvent for Solution for Injection/Infusion (TPA-05, 50 mg/vial) Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Proposed INN: ALT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years (or above legal age, e.g. UK =16 years) 2. ARDS with PaO2*/FiO2 ratio >100 and =300 , either on non-invasive ventilator support, OR on mechanical ventilation (=65 years) yes F.1.3.1 Number of subjects for this age range 178

Exclusion criteria

Exclusion criteria: 1. Massive confirmed pulmonary embolism (PE) with haemodynamic instability at trial entry 2. Patients on mechanical ventilation for longer than 48 hours 3. Chronic pulmonary disease i.e. with known forced expiratory volume in 1 second (FEV1) 48 hours after admission 6. Patients with known hypersensitivity to the active substance alteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients 7. Significant bleeding disorder at present or within the past 3 months, known haemorrhagic diathesis 8. 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 9. Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) 10. History or evidence or suspicion of intracranial haemorrhage including sub-arachnoid haemorrhage 11. Severe uncontrolled arterial hypertension (according to the investigator`s judgement) 12. Major surgery or significant trauma in the past 10 days, recent trauma to head or cranium 13. Cardiac arrest and/or cardiopulmonary resuscitation during the current hospital stay 14. Obstetrical delivery within the past 10 days 15. Severe hepatic dysfunction, including biopsy confirmed hepatic cirrhosis, portal hypertension, hepatic encephalopathy, or active hepatitis 16. Bacterial endocarditis, pericarditis 17. Acute pancreatitis 18. Documented ulcerative gastro-intestinal disease during the last 3 months 19. Severe heart failure (New York Heart Association Class IV) 20. Arterial aneurysms, arterial/venous malformations 21. Malignancy (Stage IV) 22. Haemorrhagic stroke or stroke of unknown origin at any time 23. Ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 months Further criteria apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and safety of intravenous alteplase in ARDS triggered by COVID-19.;Secondary Objective: Not applicable;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: 1) up to day 28	—

Measure

Time frame

Main Objective: To evaluate the efficacy and safety of intravenous alteplase in ARDS triggered by COVID-19.;Secondary Objective: Not applicable;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: 1) up to day 28

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Secondary

Measure	Time frame
Secondary end point(s): 1) All cause mortality at Day 28 2) Number of ventilator-free days from start of treatment to Day 28 3) Improvement of Sequential (sepsis-related) Organ Failure Assessment (SOFA) score by =2 points from baseline to end of Day 6 4) Major bleeding events (MBE) (according to International Society on Thrombosis and Haemostasis [ISTH] definition until Day 6 5) Daily average PaO2/FiO2 ratio (or inferred PaO2/FiO2 ratio from SpO2) change from baseline to Day 6 6) All-cause mortality or on mechanical ventilation at Day 28 ;Timepoint(s) of evaluation of this end point: 1) Day 28 2) Day 28 3) Day 6 4) Day 6 5) Day 6 5) Day 28	—

Measure

Time frame

Secondary end point(s): 1) All cause mortality at Day 28 2) Number of ventilator-free days from start of treatment to Day 28 3) Improvement of Sequential (sepsis-related) Organ Failure Assessment (SOFA) score by =2 points from baseline to end of Day 6 4) Major bleeding events (MBE) (according to International Society on Thrombosis and Haemostasis [ISTH] definition until Day 6 5) Daily average PaO2/FiO2 ratio (or inferred PaO2/FiO2 ratio from SpO2) change from baseline to Day 6 6) All-cause mortality or on mechanical ventilation at Day 28 ;Timepoint(s) of evaluation of this end point: 1) Day 28 2) Day 28 3) Day 6 4) Day 6 5) Day 6 5) Day 28

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Countries

Austria, Belgium, Brazil, China, Denmark, France, Germany, Italy, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, United Kingdom

Contacts

Public ContactCT Disclosure & Data Transparency

Boehringer Ingelheim Pharma GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com498002430127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026