Study name |
Enoxaparin for thromboprophylaxis in hospitalized COVID‐19 patients: comparison of 40 mg o.d. versus 40 mg b.i.d. a randomized clinical trial |
Starting date |
14 May 2020 |
Contact information |
Nuccia Morici Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milano, Italy +396444 ext 2565 | nuccia.morici@ospedaleniguarda.it |
Methods |
Prospective, multicentre, open‐label, 1:1, 2‐armed, parallel‐assignment RCT |
Participants |
2712 participants, ≥ 18 years, female and male Inclusion criteria
Exclusion criteria
Patients admitted directly to an ICU
Estimated CrCl < 15 mL/min/1.73 m²
Patients needing anticoagulant for prior indication
Participants involved in other clinical studies
Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
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Interventions |
Experimental: 40 mg SC enoxaparin twice a day Comparator: 40 mg SC enoxaparin once a day |
Outcomes |
Primary
Secondary
In‐hospital major complications (time frame: 30 days). Death, VTE, use of mechanical ventilation, stroke, acute myocardial infarction and admission to an ICU
Number of DVT events (time frame: 30 days). DVT events diagnosed by serial compression ultrasonography
Sequential organ failure assessment (time frame: 30 days). Maximum SOFA score comparison between the 2 groups. The SOFA score ranges from 0‐24. Higher SOFA score is associated with a greater risk of death or prolonged ICU stay
C‐reactive protein (time frame: 30 days). To compare C‐reactive protein levels as % above the upper reference limit) among the 2 groups
Interleukin‐6 (time frame: 30 days). To compare Interleukin‐6 levels as % above the upper reference limit) among the 2 groups
D‐dimer (time frame: 30 days). To compare D‐dimer levels as % above the upper reference limit) among the 2 groups
hs‐troponin levels (time frame: 30 days). To compare hs‐troponin levels as % above the upper reference limit) among the 2 groups
ARDS (time frame: 30 days). To compare the incidence of SARS‐CoV‐2‐related ARDS between the 2 groups
Hospital stay (time frame: 30 days). To compare length of hospital stay between the 2 groups
Right ventricular function (time frame: 30 days). To compare measures of right ventricular function at transthoracic echocardiography or CT between admission and follow‐up, whenever available
Number of PE events (time frame: 30 days). PE events diagnosed by CT scan
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Notes |
NCT04366960 | No data provided |