Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

University Magna Graecia58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Acute Respiratory Failure SARS CoV 2 Infection Anticoagulants

Interventions

Enoxaparin SodiumDRUG

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

BivalirudinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time spent under invasive mechanical ventilation

number of days that patient would require invasive mechanical ventilation

Time frame: from randomization till 28 days after randomization

Secondary Outcomes

Incidence of vein thrombosis and embolism

Number of patients with diagnosis of deep vein thrombosis and/or pulmonary embolism

Time frame: from randomization till 28 days after randomization or ICU discharge

Gas Exchange

Daily evaluation of oxygenation through arterial blood gases

Time frame: Every day till 28 days after randomization or ICU discharge

Intensive Care Unit length of stay

Number of days spent in Intensive Care Unit

Time frame: Up to 1 year

Intensive Care Unit mortality

Number of patients died during the Intensive Care Unit stay