Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

NCT ID: NCT05334654

Last Updated: 2022-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2022-07-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Enoxaparin sodium

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

Group Type: ACTIVE_COMPARATOR

Enoxaparin Sodium

Intervention Type: DRUG

Enoxaparin will be subcutaneously administered at a dosage from 4000 to 8000 twice daily according

Bivalirudin

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.

Group Type: EXPERIMENTAL

Bivalirudin

Intervention Type: DRUG

Bivalirudin will be intravenously administered to obtain an activated prothrombin time (aPTT) of 1.5 fold of the normal values.

Interventions

Enoxaparin Sodium

Enoxaparin will be subcutaneously administered at a dosage from 4000 to 8000 twice daily according

Intervention Type: DRUG

Bivalirudin

Bivalirudin will be intravenously administered to obtain an activated prothrombin time (aPTT) of 1.5 fold of the normal values.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Federico Longhini

Director of the Intensive Care and Anesthesia Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Federico Longhini, MD

Role: PRINCIPAL_INVESTIGATOR

Magna Graecia University

Locations

AOU Mater Domini

Catanzaro, , Italy

Countries

Italy

Other Identifiers

Bivalirudin COVID-19

Identifier Type: -

Identifier Source: org_study_id