Overview

Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism

Status:
Terminated
Trial end date:
2021-08-08
Target enrollment:
Participant gender:
Summary
- There is a knowledge gap associated with the management of patients with COVID-19 lung injury and a laboratory picture compatible with disseminated intravascular coagulation (DIC). Clinical data to date support that COVID-19 is associated with a prothrombotic state that is not simply explained by an influx of more critically ill individuals. - These patients suffer from severe respiratory failure; hypoxemia and ventilator dependence are the primary concerns; ARDS with respiratory failure is frequently the cause of death. Macroscopic and probable microvascular thromboembolic events are a major concern in this population. - When DIC is associated with COVID-19, it predicts a very poor prognosis. - This study will evaluate the clinical efficacy and safety of low-dose IV bolus tenecteplase (TNK) together with anticoagulation compared with control patients on therapeutic anticoagulation alone in hospitalized adults diagnosed with COVID-19 and acute intermediate-risk PE. - Prospective, multicenter, randomized two-arm trial enrolling consecutive patients who meet enrollment criteria. - The study will generate evidence that low-dose TNK together with anticoagulation is beneficial in these patients
Phase:
Phase 4
Details
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborator:
Genentech, Inc.
Treatments:
Calcium heparin
Dalteparin
Enoxaparin
Enoxaparin sodium
Heparin
Heparin, Low-Molecular-Weight
Tenecteplase
Tinzaparin