EUCTR2020-001308-40-ITActive, not recruitingPhase 1
Intermediate dose enoxaparin in hospitalized patients with moderate-severe COVID-19: a pilot phase II single-arm study, INHIXACOVID19 - INHIXACOVID19
ALMA MATER STUDIORUM UNIVERSITà DI BOLOGNA0 sites100 target enrollmentStarted: June 24, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-Age >=18 y
- •-Microbiologically confirmed COVID-19 infection
- •-Patients with moderate-severe disease according to study definitions (see below)
- •-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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
Exclusion Criteria
- •Thrombocytopenia (platelet count < 50.000 mm3)
- •Coagulopathy: INR >1.5, aPTT ratio >1.4
- •Impaired renal function (clearance to creatinine less than 15 ml/min)
- •Known hypersensitivity to heparin
- •History of heparin induced thrombocytopenia
- •Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignat tumors at hig risk of haemorrahges, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations)
- •Body weight <45 or > 150 kg
- •Concomitant anticoagulant treatment for other indications ( eg atrial fibrillation, venous thromboembolism , prosthetic heart valves).
- •Dual antiplatelet therapy
- •Pregnant or breastfeeding women
Investigators
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