Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

Not Applicable

Completed

• Conditions: SARS CoV 2 Infection; Anticoagulants; Acute Respiratory Failure
• Interventions: Drug: Enoxaparin Sodium; Drug: Bivalirudin

• Registration Number: NCT05334654
• Lead Sponsor: University Magna Graecia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-15
• Study First Posted: 2022-04-19
• Study Start: 2022-04-20
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxaparin sodium	Enoxaparin Sodium	Enoxaparin sodium twice daily, according to the renal function and clinical indication
Bivalirudin	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.

Primary Outcome Measures

Name	Time	Method
Time spent under invasive mechanical ventilation	from randomization till 28 days after randomization	number of days that patient would require invasive mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
Incidence of vein thrombosis and embolism	from randomization till 28 days after randomization or ICU discharge	Number of patients with diagnosis of deep vein thrombosis and/or pulmonary embolism
Intensive Care Unit length of stay	Up to 1 year	Number of days spent in Intensive Care Unit
Intensive Care Unit mortality	Up to 1 year	Number of patients died during the Intensive Care Unit stay
Gas Exchange	Every day till 28 days after randomization or ICU discharge	Daily evaluation of oxygenation through arterial blood gases

Trial Locations

Locations (1)

AOU Mater Domini; 🇮🇹 Catanzaro, Italy