NCT04366960.

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	Multicentre, prospective, open‐label, 1:1, 2‐armed, parallel‐assignment RCT
Participants	2712 participants, ≥ 18 years, female and male Inclusion criteria All‐comers patients aged ≥ 18 years and admitted to hospital with laboratory‐confirmed SARS‐CoV‐2 infection Exclusion criteria Patients admitted directly to an ICU Estimated creatinine clearance < 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
Interventions	Experimental: 40 mg SC enoxaparin twice a day Comparator: 40 mg SC enoxaparin once a day
Outcomes	Primary Incidence of VTE detected by imaging (time frame: 30 days). DVT events diagnosed by serial compression ultrasonography and PE events diagnosed by CT scan 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 trans‐thoracic echocardiography or CT between admission and follow‐up, whenever available Number of PE events (time frame: 30 days). PE events diagnosed by CT scan
Notes	NCT04366960 | No data provided