TY - JOUR
T1 - Enoxaparin Thromboprophylaxis in Children Hospitalized for COVID-19
T2 - A Phase 2 Trial
AU - COVID-19 Anticoagulation in Children – Thromboprophylaxis (COVAC-TP) Trial Investigators
AU - Sochet, Anthony A.
AU - Morrison, John M.
AU - Jaffray, Julie
AU - Godiwala, Nihal
AU - Wilson, Hope P.
AU - Thornburg, Courtney D.
AU - Bhat, Rukhmi V.
AU - Zia, Ayesha
AU - Lawrence, Courtney
AU - Kudchadkar, Sapna R.
AU - Hamblin, Frances
AU - Russell, Christopher J.
AU - Streiff, Michael B.
AU - Spyropoulos, Alex C.
AU - Amankwah, Ernest K.
AU - Goldenberg, Neil A.
N1 - Publisher Copyright:
© 2022 American Academy of Pediatrics. All rights reserved.
PY - 2022/7/1
Y1 - 2022/7/1
N2 - BACKGROUND: Evidence regarding the safety and efficacy of anticoagulant thromboprophylaxis among pediatric patients hospitalized for coronavirus disease 2019 (COVID-19) is limited. We sought to evaluate safety, dose-finding, and preliminary efficacy of twice-daily enoxaparin as primary thromboprophylaxis among children hospitalized for symptomatic COVID-19, including primary respiratory infection and multisystem inflammatory syndrome in children (MISC). METHODS: We performed a phase 2, multicenter, prospective, open-label, single-arm clinical trial of twice-daily enoxaparin (initial dose: 0.5mg/kg per dose; max: 60mg; target anti-Xa activity: 0.20–0.49IU/mL) as primary thromboprophylaxis for children <18 years of age hospitalized for symptomatic COVID-19. Study endpoints included: cumulative incidence of International Society of Thrombosis and Haemostasis-defined clinically relevant bleeding; enoxaparin dose-requirements; and cumulative incidence of venous thromboembolism within 30-days of hospital discharge. Descriptive statistics summarized endpoint estimates that were further evaluated by participant age (±12 years) and clinical presentation. RESULTS: Forty children were enrolled and 38 met analyses criteria. None experienced clinically relevant bleeding. Median (interquartile range) dose to achieve target anti-Xa levels was 0.5 mg/kg (0.48–0.54). Dose-requirement did not differ by age (0.5 [0.46–0.52] mg/kg for age $12 years versus 0.52 [0.49–0.55] mg/kg for age <12 years, P 5 .51) but was greater for participants with MISC (0.52 [0.5–0.61] mg/kg) as compared with primary COVID-19 (0.48 [0.39–0.51] mg/kg, P 5 .010). Two children (5.3%) developed central-venous catheter-related venous thromboembolism. No serious adverse events were related to trial intervention. CONCLUSIONS: Among children hospitalized for COVID-19, thromboprophylaxis with twice-daily enoxaparin appears safe and warrants further investigation to assess efficacy.
AB - BACKGROUND: Evidence regarding the safety and efficacy of anticoagulant thromboprophylaxis among pediatric patients hospitalized for coronavirus disease 2019 (COVID-19) is limited. We sought to evaluate safety, dose-finding, and preliminary efficacy of twice-daily enoxaparin as primary thromboprophylaxis among children hospitalized for symptomatic COVID-19, including primary respiratory infection and multisystem inflammatory syndrome in children (MISC). METHODS: We performed a phase 2, multicenter, prospective, open-label, single-arm clinical trial of twice-daily enoxaparin (initial dose: 0.5mg/kg per dose; max: 60mg; target anti-Xa activity: 0.20–0.49IU/mL) as primary thromboprophylaxis for children <18 years of age hospitalized for symptomatic COVID-19. Study endpoints included: cumulative incidence of International Society of Thrombosis and Haemostasis-defined clinically relevant bleeding; enoxaparin dose-requirements; and cumulative incidence of venous thromboembolism within 30-days of hospital discharge. Descriptive statistics summarized endpoint estimates that were further evaluated by participant age (±12 years) and clinical presentation. RESULTS: Forty children were enrolled and 38 met analyses criteria. None experienced clinically relevant bleeding. Median (interquartile range) dose to achieve target anti-Xa levels was 0.5 mg/kg (0.48–0.54). Dose-requirement did not differ by age (0.5 [0.46–0.52] mg/kg for age $12 years versus 0.52 [0.49–0.55] mg/kg for age <12 years, P 5 .51) but was greater for participants with MISC (0.52 [0.5–0.61] mg/kg) as compared with primary COVID-19 (0.48 [0.39–0.51] mg/kg, P 5 .010). Two children (5.3%) developed central-venous catheter-related venous thromboembolism. No serious adverse events were related to trial intervention. CONCLUSIONS: Among children hospitalized for COVID-19, thromboprophylaxis with twice-daily enoxaparin appears safe and warrants further investigation to assess efficacy.
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U2 - 10.1542/peds.2022-056726
DO - 10.1542/peds.2022-056726
M3 - Article
C2 - 35484817
AN - SCOPUS:85131674885
SN - 0031-4005
VL - 150
JO - Pediatrics
JF - Pediatrics
IS - 1
M1 - e2022056726
ER -