A Phase 3 interventional study of Enoxaparin in Covid19 and Thrombosis, sponsored by ASST Fatebenefratelli Sacco. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by ASST Fatebenefratelli Sacco · Phase 3, Interventional, and Treatment
SINGLE CENTER PHASE III INTERVENTIONAL RANDOMIZED CONTROLLED TRIAL comparing efficacy and safety of enoxaparin at prophylactic dose (standard treatment) and enoxaparin at therapeutic dose (OFF-LABEL treatment) in 300 COVID-19 infected patients with moderate-severe respiratory failure (PaO2/FiO2\<250) and/or increased D-dimer levels enrolled in different Units (Infectious disease, Internal Medicine, Emergency Medicine, Pneumology) of Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco (ASST-FBF-SACCO).
Patients with COVID-19 are at high risk of developing a venous thromboembolism (VTE) and it is essential that effective thromboprophylaxis with parenteral drugs (LMWH, UFH) is considered for all patients admitted to hospital especially in case of severe pneumonia.
The aim of the study is the evaluation of efficacy and safety of enoxaparin at prophylactic dose (standard treatment) as compared to enoxaparin at therapeutic dose (OFF-LABEL treatment) in 300 COVID-19 infected patients with moderate-severe respiratory failure (PaO2/FiO2\<250) and/or increased D-dimer levels.
After the admission to different Units (Infectious disease, Internal Medicine, Emergency Medicine, Pneumology), enoxaparin at prophylactic dose (standard of care) will be prescribed to all patients.
The randomization of the single patient will be made when the the inclusion criteria (PaO2/FiO2 \<250 and/or D-dimer >2000 ng/) will be satisfied. Patients with increased bleeding risk will be excluded (exclusion criteria).
Patients will be divided into two arms:
In both arms, enoxaparin treatment will be monitored clinically and with first and second line laboratory tests Venous compression ultrasound (CUS) will be performed at admission and after 7 days in case of a first negative exam and elevated D-Dimer levels, to rule out deep vein thrombosis.
Enoxaparin at prophylactic dose (4000 IU) will be maintained in all patients for 4 weeks after discharge.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 142 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →ASST Fatebenefratelli Sacco is the lead sponsor of 36 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Enoxaparin at prophylactic dose: standard 4.000 IU QD via subcutaneous injection (6000 IU if body weight\>100 kg)
Drug: Enoxaparin
Enoxaparin at therapeutic dose : 70 U/Kg b.i.d. (every 12 h) In order to easily calculate the correct therapeutic dose of enoxaparin for each patient, a simplified categorization will be applied, as follows: * weight \< 65 Kg: 4.000 IU b.i.d. (every 12 h) * weight ≥ 65 Kg: 6.000 IU b.i.d. (every 12 h) * weight ≥ 100 Kg: 8.000 IU b.i.d. (every 12 h) The most appropriate dose will be evaluated in patients with creatinine clearance between 30 and 50 ml/min
Drug: Enoxaparin
subcutaneous injections
Also known as: Clexane
Mortality rate
Mortality registered during the time frame
Time frame: 30 days from enrollment
Progression of respiratory failure
Progression of respiratory failure defined as duration of continuous positive pressure ventilation (CPAP)
Time frame: 30 days from enrollment
Progression of respiratory failure
Progression of respiratory failure defined as percentage of patients admitted to ICU
Time frame: 30 days from enrollment
Progression of respiratory failure
Progression of respiratory failure defined as percentage of patients undergoing oro-tracheal intubation
Time frame: 30 days from enrollment
Number of major bleeding episodes
Major bleeding (ISTH criteria) and/or clinically relevant non-major bleeding
Time frame: up to 6 months from randomization
Respiratory function improvement
Amelioration of the respiratory function defined as a PaO2/FiO2 increase \> 300 and / or respiratory rate (RR) \< 20 breaths per min
Time frame: at 72 hours
Respiratory function improvement
Amelioration of the respiratory function defined as a PaO2/FiO2 increase \> 300 and / or respiratory rate (RR) \< 20 breaths per min
Time frame: 1 week from randomization
Number of major cardiovascular events
numbers of myocardial infarction and stroke within the time frame
Time frame: 6 months from randomization
Deep Vein Thrombosis
Numbers of Deep Vein Thrombosis at CUS examination within the time frame
Time frame: 6 months from randomization
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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ASST Fatebenefratelli Sacco