- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04505592
Tenecteplase in Patients With COVID-19
Tenecteplase With Concomitant Anticoagulation for Severe Acute Respiratory Failure in Patients With COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10029
- Mount Sinai Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo control
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Patients will receive placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
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Experimental: Tenecteplase
First 20 patients randomized to treatment will receive tenecteplase 0.25 mg/kg (maximum 25 mg).
Last 20 patients randomized to treatment will receive tenecteplase 0.50 mg/kg (maximum 40 mg).
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First 20 patients randomized to treatment arm will receive 0.25 mg/kg of tenecteplase.
Next 20 patients randomized to treatment arm will receive 0.50 mg/kg of tenecteplase.
Both will receive concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Free of Respiratory Failure
Time Frame: 28 Days
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The number of patients free of respiratory failure defined as not requiring high flow nasal cannula, non-rebreather, noninvasive positive pressure ventilation, or mechanical ventilation at 28 days
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28 Days
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Number of Participants With Occurrences of Bleeding
Time Frame: 28 days
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Safety as assessed by number of participants with occurrences of intracranial bleeding or major bleeding
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With In-hospital Deaths at 14 Days
Time Frame: 14 days
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Number of patients who expired in the hospital within the first 14 days of their participation in the study
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14 days
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Number of Participants With Death at 28 Days
Time Frame: 28 days
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Number of participants who expired by 28 days/end of study
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28 days
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Number of Ventilator-free Days
Time Frame: 28 days
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Number of ventilator-free days in 28 days period
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28 days
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Number of Respiratory Failure-free Days
Time Frame: 28 days
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Respiratory failure-free defined as not requiring high flow nasal cannula, non-rebreather, noninvasive positive pressure ventilation, or mechanical ventilation.
Number of respiratory failure-free days in 28 days period.
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28 days
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Number of Vasopressor-free Days
Time Frame: 28 days
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Number of vasopressor-free days over 28 days period
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28 days
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Number of Vasopressor Doses at 24 Hours
Time Frame: 24 hours and 72 hours
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24 hours and 72 hours
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P/F Ratio
Time Frame: 24 hours and 72 hours
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The P/F ratio equals the arterial pO2 ("P") from the ABG divided by the FIO2 ("F") - the fraction (percent) of inspired oxygen that the patient is receiving expressed as a decimal (40% oxygen = FIO2 of 0.40). Ratio of arterial pO2 over fraction of inspired oxygen that the person is receiving. Normal P/F Ratio is ≥ 400. 300 to 200 is considered mild ARDS 200 to 100 is considered moderate ARDS Anything below 100 is considered severe ARDS. |
24 hours and 72 hours
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Number of ICU-free Days
Time Frame: 28 days
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Number of days the patient spent outside the ICU
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28 days
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Hospital Length of Stay
Time Frame: up to 29 days
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Length of time the patient spent in the hospital, including ICU
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up to 29 days
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Number of Participants With New-onset Renal Failure
Time Frame: 28 days
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Number of patients who experienced renal failure during the course of the study
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28 days
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Number of Participants With Need for Renal Replacement Therapy
Time Frame: 28 days
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Number of patients who underwent renal replacement treatment for their renal failure
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28 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hooman Poor, MD, Icahn School of Medicine at Mount Sinai
- Study Director: J Mocco, MD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Respiratory Insufficiency
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Tenecteplase
Other Study ID Numbers
- GCO 20-1764
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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