Randomised controlled trial comparing efficacy and safety of high versus low Low-Molecular Weight Heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol

AbstractObjectivesTo assess whether high doses of Low Molecular Weight Heparin (LMWH) (i.e. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (i.e., Enoxaparin 4000 IU once day), in hospitalized patients with COVID19 not requiring Invasive Mechanical Ventilation [IMV], are:more effective in preventing clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first:DeathAcute Myocardial Infarction [AMI]Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]Need of either:Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orIMV in patients who at randomisation were receiving standard oxygen therapyIMV in patients who at randomisation were receiving non-invasive mechanical ventilationSimilar in terms of major bleeding riskTrial designMulticentre, randomised controlled, superiority, open label, parallel group, two arms (1:1 ratio), in-hospital study.ParticipantsInpatients will be recruited from 7 Italian Academic and non-Academic Internal Medicine Units, 2 Infectious Disease Units and 1 Respiratory Disease Unit.Inclusion Criteria (all required)Age> 18 and4 times the upper level of normal reference rangeSepsis-Induced Coagulopathy (SIC) score>4No need of IMVExclusion CriteriaAge80 yearsIMVThrombocytopenia (platelet count1.5, aPTT ratio> 1.4Impaired renal function (eGFR calculated by CKD-EPI Creatinine equation5 minutesHaematuria that was macroscopic and was spon...
Source: Trials - Category: Research Source Type: clinical trials

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Missing Electronic Supplementary Materials.
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