ROLE OF HEPARIN IN THE PREVENTION OF THROMBOEMBOLISM IN PATIENTS WITH COVID-19 AND RESPIRATORY FAILURE
- Conditions
- Patients with confirmed SARS-CoV-2 infection and respiratory failure will be randomized to receive two different doses of low molecular weight heparin (LMWH).Therapeutic area: Diseases [C] - Virus Diseases [C02]MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2020-005884-29-IT
- Lead Sponsor
- IVERSITà DEGLI STUDI DI PERUGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 652
- Age >= 18 years
- Diagnosis of COVID-19 confirmed by RT-PCR with pneumonia detected by chest X-ray or ultrasonography or computed tomography
- Severe respiratory failure (PaO2/FiO2 <250)
- 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 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 392
- Need for invasive mechanical ventilation
- Any contraindication to LMWH (known hypersensitivity, history of heparin induced thrombocytopenia, stage IV or V renal failure,.. )
- Platelet count <30000/mmc
- Indication for therapeutic anticoagulation
- Evidence of active bleeding
- Recent stroke in the preceding 4 weeks
- Women who are pregnant or breastfeeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method