The clinical trial ofEnoxaparin at Prophylactic or Therapeutic Doses in COVID-19 begins in Italy
ASST Fatebenefratelli Sacco is conducting the clinical trial Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19 (EMOS-COVID).
Patients with COVID-19 are at high risk of developing a venous thromboembolism (VTE) and it is essential that effective thromboprophylaxis with parenteral drugs (LMWH, UFH) is considered for all patients admitted to hospital especially in case of severe pneumonia.
The aim of the study is the evaluation of efficacy and safety of enoxaparin at prophylactic dose (standard treatment) as compared to enoxaparin at therapeutic dose (OFF-LABEL treatment) in 300 COVID-19 infected patients with moderate-severe respiratory failure (PaO2/FiO2<250) and/or increased D-dimer levels.
After the admission to different Units (Infectious disease, Internal Medicine, Emergency Medicine, Pneumology), enoxaparin at prophylactic dose (standard of care) will be prescribed to all patients.
It is planned to include 300 participants.
Actual study start date is July 27, 2020. The researchers expect to complete the study by July 31, 2021.
One primary outcome measure is Mortality rate, Progression of respiratory failure, and Number of major bleeding episodes.
Among the exclusion criteria are:
- history of bleeding (peptic ulcer, esophageal varices, cerebral aneurysm, cancer at high risk of bleeding, cirrhosis, hemorrhagic stroke < 1 year)
- thrombocytopenia (<100 x109/L)
- anemia (Hb < 8 g/dl)
- coagulation abnormalities (PT e/o aPTT > 1.5; fibrinogen < 150 mg/dl)
- deep vein thrombosis or pulmonary embolism
and others.
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04646655) Milan, Italy.
