Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients
Sponsored by University Magna Graecia
About this trial
Last updated 3 years ago
Study ID
Bivalirudin COVID-19
Status
Completed
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 3 years ago
What is this trial about?
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.
What are the participation requirements?
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