drugset / Trial / NCT05334654

Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

NCT05334654

Completed 58 enrolled University Magna Graecia
RandomizedParallel-groupTriple-blindTreatment

Summary

Coronavirus Disease (COVID-19) is characterized by a hypercoagulable state, sometimes difficult to be managed with heparin. Bivalirudin, a member of the direct thrombin inhibitor drug class, offers potential advantages compared to heparin, including to its ability to exert its effect by directly attaching to and inhibiting freely circulating and fibrin-bound thrombin. Investigators have therefore designed this pilot open-label randomized controlled trial to assess if a off-label infusion of bivalirudin may reduce thrombosis, mortality, Intensive Care Unit (ICU) length of stay and increase ventilator free days of patients admitted in ICU for acute respiratory failure due to COVID-19, as compared to first-line treatment with heparin.

Timeline

Start
2022-04-20
Primary completion
2022-06-30
Completion
2022-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bivalirudin Peptide 0.2 mg/kg Intravenous
Comparator Enoxaparin sodium Other / unclassified Subcutaneous