Acute Respiratory Failure, Anticoagulants, SARS CoV 2 Infection
Conditions
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.
Interventions
DRUGEnoxaparin Sodium
Enoxaparin will be subcutaneously administered at a dosage from 4000 to 8000 twice daily according
DRUGBivalirudin
Bivalirudin will be intravenously administered to obtain an activated prothrombin time (aPTT) of 1.5 fold of the normal values.
Sponsors
University Magna Graecia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Investigators and Outcome assessors will not take part in the care of patients. Data will be provide in anonymous form without any indication to the assigned treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time spent under invasive mechanical ventilation | from randomization till 28 days after randomization | number of days that patient would require invasive mechanical ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Gas Exchange | Every day till 28 days after randomization or ICU discharge | Daily evaluation of oxygenation through arterial blood gases |
| 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 |
Countries
Italy
Outcome results
None listed