Tenecteplase in Patients With COVID-19

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, ARDS, thrombolysis, tenecteplase Read More

Inclusion Criteria

• Patient/legally authorized representative has completed the Informed Consent Form
• Age ≥18 years
• Ability to comply with the study protocol, in the investigator's judgment
• Respiratory failure secondary to COVID-19 requiring mechanical ventilation for no greater than 24 hours, or high-flow nasal cannula (HFNC),non-rebreather (NRB) mask or non-invasive positive pressure ventilation (NIPPV) for no greater than 48 hours
• Confirmed infection with SARS-CoV-2 virus (PCR positive within 14 days)
• Elevated D-dimer (>6 times upper limit of normal within past 72 hours)
• For patient who are intubated >12 hours prior to randomization or with any evidence of neurologic deficit a head CT within 12 hours demonstrating no evidence of acute or subacute infarct or hemorrhage

Exclusion Criteria

• Current participation in another investigational drug study within the prior 7 days
• Known hypersensitivity or allergy to any ingredients of tenecteplase
• Active internal bleeding
• Known bleeding diathesis
• Use of one of the new oral anticoagulants within the last 48 hours (dabigatran, rivaroxaban, apixaban, edoxaban)
• Treatment with a thrombolytic within the last 3 months prior to randomization (exception for the use of Cathflo alteplase for occlusions of central venous catheters)
• Baseline platelet count <80,000/L (results must be available prior to treatment)
• Baseline blood glucose >400 mg/dL (22.20 mmol/L)
• Baseline blood glucose <50 mg/dL needs to be normalized prior to randomization
• Intracranial or intraspinal surgery or trauma within 2 months
• Other, non-COVID-19 related, serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months
• History of acute ischemic stroke in the last 90 days
• History of intracranial bleeding, including hemorrhagic stroke
• Presumed septic embolus; suspicion of bacterial endocarditis
• Mechanical ventilation > 24 hours, HFNC, NRB, NIPPV, or any combination, for greater than 48 hours
• Mechanical ventilation, HFNC, NRB, or NIPVV (for reasons other than obstructive sleep apnea) within the prior 30 days (excluding 48 hours prior to randomization)
• Moribund status suggesting imminent vascular collapse and inability to survive > 72 hours (investigator determination)
• Uncontrolled hypertension defined as systolic BP > 180 mm Hg and/or diastolic BP > 110 mm Hgb
• Age > 75 years
• History of traumatic brain injury within 2 months
• Recent head trauma with fracture or brain injury
• History of Heparin Induced Thrombocytopenia (HIT) and/or other hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency
• INR > 2 or recent oral anticoagulant therapy with INR >1.7
• Pregnancy or lactation within the prior 30 days; women of childbearing age (<55 years old) should have documentation of a negative pregnancy test
• Chronic liver disease defined as > Childs-Pugh Class B
• Atrial fibrillation, mitral stenosis, or known left heart thrombosis
• Any other condition that, in the opinion of the investigator, precludes administration of tenecteplase or poses a significant hazard to the patient receives tenecteplase