Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19 (EMOS-COVID)
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|ClinicalTrials.gov Identifier: NCT04646655|
Recruitment Status : Recruiting
First Posted : November 30, 2020
Last Update Posted : November 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Thrombosis||Drug: Enoxaparin||Phase 3|
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:
- arm A: enoxaparin at prophylactic dose (standard 4.000 IU; 6000 UI if body weight>100 kg)
- arm B: enoxaparin at therapeutic dose (70 U/Kg b.i.d. every 12 h)
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enoxaparin at Prophylactic or Therapeutic Doses With Monitoring of Outcomes in Subjects Infected With COVID-19: a Pilot Study on 300 Cases Enrolled at ASST-FBF-Sacco|
|Actual Study Start Date :||July 27, 2020|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Active Comparator: Enoxaparin at prophylactic dose
Enoxaparin at prophylactic dose: standard 4.000 IU QD via subcutaneous injection (6000 IU if body weight>100 kg)
Other Name: Clexane
Experimental: Enoxaparin at therapeutic dose
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:
Other Name: Clexane
- Mortality rate [ Time Frame: 30 days from enrollment ]Mortality registered during the time frame
- Progression of respiratory failure [ Time Frame: 30 days from enrollment ]Progression of respiratory failure defined as duration of continuous positive pressure ventilation (CPAP)
- Progression of respiratory failure [ Time Frame: 30 days from enrollment ]Progression of respiratory failure defined as percentage of patients admitted to ICU
- Progression of respiratory failure [ Time Frame: 30 days from enrollment ]Progression of respiratory failure defined as percentage of patients undergoing oro-tracheal intubation
- Number of major bleeding episodes [ Time Frame: up to 6 months from randomization ]Major bleeding (ISTH criteria) and/or clinically relevant non-major bleeding
- Respiratory function improvement [ Time Frame: at 72 hours ]Amelioration of the respiratory function defined as a PaO2/FiO2 increase > 300 and / or respiratory rate (RR) < 20 breaths per min
- Respiratory function improvement [ Time Frame: 1 week from randomization ]Amelioration of the respiratory function defined as a PaO2/FiO2 increase > 300 and / or respiratory rate (RR) < 20 breaths per min
- Number of major cardiovascular events [ Time Frame: 6 months from randomization ]numbers of myocardial infarction and stroke within the time frame
- Deep Vein Thrombosis [ Time Frame: 6 months from randomization ]Numbers of Deep Vein Thrombosis at CUS examination within the time frame
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646655
|Contact: Maddalena A Wu, M.D.||+firstname.lastname@example.org|
|Contact: Massimo Arquati, M.D.||+email@example.com|
|ASST Fatebenefratelli Sacco||Recruiting|
|Milan, Italy, 20157|
|Contact: Maddalena A Wu, M.D. +393392883379 firstname.lastname@example.org|
|Principal Investigator:||Maddalena A Wu, M.D.||ASST Fatebenefratelli Sacco|