Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19

• Status: Recruiting
• Trial end date: 2021-07-31
• Target enrollment: 0
• Participant gender: All

Summary

SINGLE CENTER PHASE III INTERVENTIONAL RANDOMIZED CONTROLLED TRIAL comparing efficacy and safety of enoxaparin at prophylactic dose (standard treatment) and 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 enrolled in different Units (Infectious disease, Internal Medicine, Emergency Medicine, Pneumology) of Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco (ASST-FBF-SACCO).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ASST Fatebenefratelli Sacco
• Collaborators: Manuela Nebuloni; Massimo Arquati; Riccardo Colombo; Spinello Antinori; Umberto Russo
• Treatments: Enoxaparin

Criteria

Inclusion Criteria:

• COVID-19 related pneumonia with moderate-severe respiratory failure (PaO2/FiO2<250) and/or markedly increased D-dimer level (>2000 ng/mL)

• Signed informed consent

Exclusion Criteria:

• age < 18 and > 80 yrs

• 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)

• consumption coagulopathy (ISTH criteria) [15, 16]

• deep vein thrombosis or pulmonary embolism

• dual antiplatelet therapy

• ongoing anticoagulant therapy

• allergic reaction to LMWH

• previous heparin-induced thrombocytopenia

• major surgery < 1 month; neurosurgery <3 months; eye surgery <3 months

• pregnancy

• arterial hypertension (SBPS>160 mm Hg; DBP>100 mm Hg)

• renal failure (creatinine clearance 30 ml/min)

• ICU admission or endotracheal intubation