Tenecteplase in Patients With COVID-19

ID#: NCT04505592

Age: 18 - 75 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: September 25, 2020

End Date: April 01, 2021

Contact Information:
Denise Balili, MS
212-241-3374
Lisa Genadry
212-241-9018
Summary:

This is a placebo-controlled, double blind, randomized, Phase II dose escalation study intended to evaluate the potential safety and efficacy of tenecteplase for the treatment of COVID-19 associated respiratory failure. The hypothesis is that administration of the drug, in conjunction with heparin anticoagulation, will improve patients' clinical outcomes.

Eligibility:

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