EUCTR2020-002214-40-ITActive, not recruitingPhase 1
ENOXAPARIN AT PROPHYLACTIC OR THERAPEUTIC DOSES WITH MONITORING OF OUTCOMES IN SUBJECTS INFECTED WITH COVID-19: PILOT STUDY ON 300 CASES ENROLLED AT ASST FBF SACCO - EMOS-COVID
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ASST FATEBENEFRATELLI SACCO
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-COVID-19 related pneumonia associated with moderate-severe respiratory failure (PaO2/FiO2<250) and/or increased D-dimer levels (>3000 ng/mL)
- •-signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
Exclusion Criteria
- •- age < 18 e > 80 anni
- •-history of bleeding (peptic ulcer, esophageal r, cerebral aneurysm, cancer at high risk of bleeding, cirrhosi, hemorragic stroke < 1 year)
- •-thrombocytopenia (<100 x109/L)
- •-anemia (Hb < 8 g/dl)
- •-coagulation abnormalities (PT and/or aPTT > 1.5; fibrinogen < 150 mg/dl)
- •-consumption coagulopathy (ISTH criteria)
- •-deep venous thrombosis and/or pulmonary embolism
- •-dual antiplatelet therapy
- •-anticoagulant therapy
- •-LMWH allergy
- •-heparin induced thrombocytopenia
- •-major surgery < 1 month; neurosurgery <3 months; eye surgery <3 months
- •-pregnancy
- •-blood arterial hypertension (SBP>160 mm Hg; DBP>100 mm Hg)
- •-renal failure (creatinine clearance < 30 ml/min
- •-ICU admission or endotracheal intubation
- •-PaO2/FiO2 >250
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