Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

University Magna Graecia

Status: Completed

Conditions: SARS CoV 2 Infection; Anticoagulants; Acute Respiratory Failure

Treatments: Drug: Bivalirudin; Drug: Enoxaparin Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT05334654

Bivalirudin COVID-19

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

Enoxaparin sodium

Active Comparator group

Description:

Enoxaparin sodium twice daily, according to the renal function and clinical indication

Treatment:

Drug: Enoxaparin Sodium

Bivalirudin

Experimental group

Description:

Bivalirudin will be administered by continuous infusion, until day 7. Bivalirudin will be administered at dosage of 0,25 mg/kg in first 30 minutes, followed by continuous infusion of 0,2 mg/kg/h until 7 days. The infusion rate will be adjusted targeting a prothrombin time ratio of about 1.5.

Treatment:

Drug: Bivalirudin