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. 2022 Mar 4;2022(3):CD013739. doi: 10.1002/14651858.CD013739.pub2

NCT04646655.

Study name 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
Starting date 27 July 2020
Contact information Maddalena A Wu, M.D.
ASST Fatebenefratelli Sacco
Milan, Italy, 20157
+390239041 | maddalena.ale.wu@gmail.com
Methods Single‐centre, open‐label, 2‐armed, parallel assignment RCT
Participants 300 participants, ≥ 18 years and ≤ 80 years, female and male
Inclusion criteria:

  • COVID‐19‐related pneumonia with moderate‐severe respiratory failure (PaO2/FiO2 < 250) and/or markedly increased D‐dimer level (> 2000 ng/mL)

  • Signed informed consent


Exclusion criteria:

  • Age < 18 and > 80 years

  • History of bleeding (peptic ulcer, oesophageal varices, cerebral aneurysm, cancer at high risk of bleeding, cirrhosis, hemorrhagic stroke < 1 year)

  • Thrombocytopenia (< 100 x 109/L)

  • Anemia (Hb < 8 g/dL)

  • Coagulation abnormalities (PT or aPTT > 1.5; fibrinogen < 150 mg/dL)

  • Consumption coagulopathy (ISTH criteria) (15, 16)

  • DVT or PE

  • Dual antiplatelet therapy

  • Ongoing anticoagulant therapy

  • Allergic reaction to LMWH

  • Previous HIT

  • Major surgery < 1 month; neurosurgery < 3 months; eye surgery < 3 months

  • Pregnancy

  • Arterial hypertension (SBP > 160 mmHg; DBP > 100 mmHg)

  • Renal failure (CrCl 30 mL/min)

  • ICU admission or endotracheal intubation
Interventions Experimental: enoxaparin at therapeutic dose

  • Enoxaparin at therapeutic dose: 70 U/kg twice daily (every 12 h)

  • In order to easily calculate the correct therapeutic dose of enoxaparin for each participant, a simplified categorisation will be applied, as follows:

    • weight < 65 kg: 4000 IU twice daily (every 12 h)

    • weight ≥ 65 kg: 6000 IU twice daily (every 12 h)

    • weight ≥ 100 kg: 8000 IU twice daily (every 12 h).

  • The most appropriate dose will be evaluated in participants with CrCl between 30 and 50 mL/min


Comparator: enoxaparin at prophylactic dose

  • Enoxaparin at prophylactic dose: standard 4000 IU once daily via SC injection (6000 IU if body weight > 100 kg)
Outcomes Primary

  • Mortality rate (time frame: 30 days from enrolment)

  • Progression of respiratory failure (time frame: 30 days from enrolment)

  • Progression of respiratory failure (time frame: 30 days from enrolment)

  • Progression of respiratory failure (time frame: 30 days from enrolment)

  • Number of major bleeding episodes (time frame: up to 6 months from randomisation)


Secondary

  • Respiratory function improvement (time frame: at 72 h)

    • Amelioration of the respiratory function defined as a PaO2/FiO2 increase > 300 and/or respiratory rate < 20 breaths/min

  • Respiratory function improvement (time frame: 1 week from randomisation)

  • Number of major cardiovascular events (time frame: 6 months from randomisation)

  • DVT (time frame: 6 months from randomisation)
Notes NCT04646655 | No data provided