Enoxaparin Thromboprophylaxis in Children Hospitalized for COVID-19: A Phase 2 Trial.

Abstract

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 = .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 = .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.

• Authors: Anthony A Sochet, John M Morrison, Julie Jaffray, Nihal Godiwala, Hope P Wilson, Courtney D Thornburg, Rukhmi V Bhat, Ayesha Zia, Courtney Lawrence, Sapna R Kudchadkar, Frances Hamblin, Christopher J Russell, Michael B Streiff, Alex C Spyropoulos, Ernest K Amankwah, Neil A Goldenberg, COVID-19 Anticoagulation in Children – Thromboprophylaxis (COVAC-TP) Trial Investigators
• Journal: Pediatrics (Pediatrics) Vol. 150 Issue 1 (07 01 2022) ISSN: 1098-4275 [Electronic] United States
• PMID: 35484817 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2022 by the American Academy of Pediatrics.

Chemical References

• Anticoagulants
• Enoxaparin

Topics

• Anticoagulants (adverse effects)
• COVID-19 (complications)
• Child
• Enoxaparin (adverse effects)
• Hemorrhage
• Humans
• Prospective Studies
• Systemic Inflammatory Response Syndrome
• Treatment Outcome
• Venous Thromboembolism (prevention & control)