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ROLE OF HEPARIN IN THE PREVENTION OF THROMBOEMBOLISM IN PATIENTS WITH COVID-19 AND RESPIRATORY FAILURE

Phase 1
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
Inclusion Criteria

- 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

Exclusion Criteria

- 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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