Remdesivir for the treatment of children hospitalized with COVID-19: a systematic review and meta-analysis

Introduction: Remdesivir (RDV) is an FDA-approved drug for the treatment of COVID-19 in children weighing at least 3.5 kg. While its safety and efficacy are well established in adults, data in pediatric populations remain limited and are largely extrapolated from adult studies. Therefore, we aimed to assess the clinical outcomes and safety of RDV in pediatric patients. Methods: We performed a systematic review and meta-analysis of studies evaluating RDV in hospitalized children under 18 years with COVID-19. The primary outcomes were in-hospital mortality and the level of respiratory support (baseline and highest). The secondary outcome was the safety profile of RDV identified by adverse events and treatment discontinuation. Meta-analysis was performed only on patients who received RDV. Results: From 1298 records, 16 studies were included. A total of 722 patients who received remdesivir were included in this study. Pooled analysis at admission showed that 28% of patients required no oxygen, 23% needed low-flow oxygen, 21% needed high-flow oxygen, 11% required non-invasive ventilation (NIV), and 9% were treated with mechanical ventilation (MV). During hospitalization, the highest respiratory support required was no oxygen in 27%, low-flow oxygen in 33%, high-flow oxygen in 32%, NIV in 5%, and MV in 19%. Overall mortality was 2% (95% CI: 0.00, 0.04, I² = 59.81%, p < 0.001). The most frequent RDV-related adverse events were elevated ALT in 11% (95% CI: 0.00, 0.42, I² = 94.02%, p < 0.001), increased AST in 10% (95% CI: 0.00, 0.41, I² = 94.56%, p = < 0.001), unspecified liver enzymes elevation in 8% (95% CI: 0.01, 0.20, I² = 81.84%, p < 0.001), and hypertension in 10% (95% CI: 0.00, 0.58, I² = 97.16%, p < 0.001). Bradycardia (3%) and increased creatinine (2%) were also reported. Almost all studies reported no drug-related serious adverse events. Conclusion: This meta-analysis suggests that RDV has an acceptable safety profile in pediatric patients with COVID-19. The most commonly reported adverse events were elevated hepatic enzymes and hypertension, with occasional reports of bradycardia and increased creatinine. The pooled results should be interpreted with caution due to study heterogeneity and possible publication bias.