Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

• Status: Not yet recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Magna Graecia
• Treatments: Bivalirudin; Enoxaparin; Enoxaparin sodium

Criteria

Inclusion Criteria:

• ratio between arterial partial pressure to inspired fraction of oxygen (PaO2/FiO2) < 200 mmHg

• age equal or greater of 18 years/old

• detection of coronavirus 2019 at the nasal swab;

• need for endotracheal intubation and invasive mechanical ventilation

Exclusion Criteria:

• known allergies to one of the two investigated drugs

• presence of hematological diseases

• pregnancy

• recent (10 days) surgery

• presence of active bleeding