Status:
COMPLETED
Tenecteplase in Patients With COVID-19
Lead Sponsor:
Hooman Poor
Collaborating Sponsors:
Genentech, Inc.
Conditions:
COVID-19
Respiratory Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 r...
Detailed Description
Patients with COVID-19 who suffer from acute hypoxemic respiratory failure have a poor prognosis. COVID-19 has been associated with a hyperinflammatory and hypercoagulable state, leading to a range of...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04505592
Start Date
September 25 2020
End Date
March 10 2022
Last Update
April 6 2023
Active Locations (1)
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1
Mount Sinai Hospital
New York, New York, United States, 10029