NCT05334654

Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

Bivalirudin Versus Enoxaparin for Anticoagulation in Critically Ill COVID-19 Patients: a Pilot Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: University Magna Graecia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Failure
• SARS CoV 2 Infection
• Anticoagulants

Interventions

Type	Name	Description
DRUG	Enoxaparin Sodium	Enoxaparin will be subcutaneously administered at a dosage from 4000 to 8000 twice daily according
DRUG	Bivalirudin	Bivalirudin will be intravenously administered to obtain an activated prothrombin time (aPTT) of 1.5 fold of the normal values.

Timeline

• Start date: 2022-04-20
• Primary completion: 2022-06-30
• Completion: 2022-07-30
• First posted: 2022-04-19
• Last updated: 2022-08-19

Locations

1 site across 1 country: Italy