Twice-Daily Enoxaparin as Primary Thromboprophylaxis in Pediatric Patients Hospitalized for COVID-19
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Pharmacology, Infection, Pediatrics, 2022
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INTRODUCTION: Evidence is limited on the safety or efficacy of anticoagulant thromboprophylaxis (TP) against hospital-associated venous thromboembolism (HA-VTE) in children hospitalized with COVID-19 and multisystem inflammatory syndrome in children (MIS-C). We aimed to assess: (1) the cumulative incidence of ISTH-defined clinically-relevant (major plus clinically-relevant non-major) bleeding (primary endpoint); (2) enoxaparin dose-requirements to achieve a goal anti-Xa activity of 0.2-0.49 U/mL (secondary endpoint); and (3) the cumulative incidence of VTE within 30-days post-discharge from hospital (exploratory efficacy). METHODS: We performed a multicenter, open-label, phase 2 clinical trial of twice-daily enoxaparin as primary TP for children 0-17 years of age hospitalized for COVID-19-related illness. The study was approved by the Johns Hopkins single IRB and required informed consent. Children received twice-daily subcutaneous enoxaparin (starting dose, 0.5mg/kg; maximum=60mg/dose) throughout hospitalization. Descriptive statistics were employed. The observation of ≤1 primary safety event was prespecified as demonstrating safety with regard to bleeding for n=38. RESULTS: Forty children were enrolled, of which 38 met criteria for analyses. Children with MIS-C (n=19) were younger (9.8 [IQR:] vs 15.4 [12.5,17.1] years of age, p  < 0.001) compared to those without MIS-C. No clinically relevant differences in demographics or clinical outcomes were noted (data not shown). Prophylactic anti-Xa levels were achieved in 35 children (92%). Median (interquartile range, IQR) enoxaparin dose required to achieve goal anti-Xa levels were as follows: age ≥ 12 years (n=18), 0.5 (IQR:0.43,0.52) mg/kg; < 12 years (n=17), 0.52 (IQR:0.49,0.55) mg/kg. There were no clinically-relevant bleeds. No SAEs were judged to be related to study intervention, including one death from COVID-19 illness. HA-VTE developed in two children (5.2%).  CONCLUSIONS: In children hospitalized for COVID-19 related illness, primary TP with subcutaneous enoxaparin twice-daily at a starting dose of 0.5 mg/kg is safe and achieves target anti-Xa levels during hospitalization in >90% of patients. Future phase 3 trials of primary TP are warranted in hospitalized children with proinflammatory conditions such as COVID-19, for which HA-VTE risk is increased.
Meta Tag
Content Type Presentation
Knowledge Area Pharmacology
Knowledge Area Infection
Knowledge Area Pediatrics
Knowledge Level Intermediate
Knowledge Level Advanced
Membership Level Select
Tag Pharmacology
Tag Pediatrics
Tag COVID-19
Tag Infectious Diseases
Year 2022
Dr. Anthony Sauchet
COVAC-TP clinical trial
pediatric patients


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