Phase 2
Completed N=13
Tenecteplase in Patients With COVID-19
Source: ClinicalTrials.gov NCT04505592 ↗Enrolled (actual)
13
Serious AEs
61.5%
Results posted
Apr 2023
Primary outcomePrimary: Number of Participants Free of Respiratory Failure — 5; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Free of Respiratory Failure |
5; 2 | — |
| PRIMARY Number of Participants With Occurrences of Bleeding |
2; 1 | — |
| SECONDARY Number of Participants With In-hospital Deaths at 14 Days |
2; 1 | — |
| SECONDARY Number of Participants With Death at 28 Days |
2; 1 | — |
| SECONDARY Number of Ventilator-free Days |
18; 19 | — |
| SECONDARY Number of Respiratory Failure-free Days |
0.5; 3 | — |
| SECONDARY Number of Vasopressor-free Days |
9; 9 | — |
| SECONDARY Number of Vasopressor Doses at 24 Hours |
0; 0; 0; 0 | — |
| SECONDARY P/F Ratio |
89; 97; 89; 78 | — |
| SECONDARY Number of ICU-free Days |
1; 1 | — |
| SECONDARY Hospital Length of Stay |
11; 13 | — |
| SECONDARY Number of Participants With New-onset Renal Failure |
0; 3 | — |
| SECONDARY Number of Participants With Need for Renal Replacement Therapy |
0; 2 | — |
Eligibility Criteria
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 400 mg/dL (22.20 mmol/L)
- Baseline blood glucose 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 ( 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
Data sourced from ClinicalTrials.gov (NCT04505592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.