drugset / Trial / NCT04558125

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

NCT04558125

RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2020-09-08
Primary completion
2021-07-10
Completion
2021-08-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenecteplase Protein / enzyme biologic 0.25 mg/kg Intravenous
Background Enoxaparin sodium Other / unclassified