Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05334654
• Other study ID #: Bivalirudin COVID-19
• Status: Completed
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: July 30, 2022

Study information

• Verified date: August 2022
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Anticoagulants
• COVID-19
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Italy	AOU Mater Domini	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent under invasive mechanical ventilation	number of days that patient would require invasive mechanical ventilation	from randomization till 28 days after randomization
Secondary	Incidence of vein thrombosis and embolism	Number of patients with diagnosis of deep vein thrombosis and/or pulmonary embolism	from randomization till 28 days after randomization or ICU discharge
Secondary	Gas Exchange	Daily evaluation of oxygenation through arterial blood gases	Every day till 28 days after randomization or ICU discharge
Secondary	Intensive Care Unit length of stay	Number of days spent in Intensive Care Unit	Up to 1 year
Secondary	Intensive Care Unit mortality	Number of patients died during the Intensive Care Unit stay	Up to 1 year