Although the severity of coronavirus disease 2019 (COVID-19) tends to be lower in children, it can still lead to severe illness, particularly among those with chronic medical conditions. While remdesivir (RDV) is one of the few approved antiviral treatments for COVID-19 in children in many countries, the available data on the safety of RDV in this population is limited. To address this knowledge gap, a multicenter study involving 65 patients retrospectively analyzed the clinical data from individuals aged <18 who were hospitalized due to severe COVID-19 (defined as SpO2 < 94% or requiring supplemental oxygen) and received at least one dose of RDV. Additionally, the study encompassed 22 patients with mild-moderate COVID-19 who were considered at high risk of developing severe disease. Nineteen children (29%) experienced mild-to-moderate adverse events (AEs) attributed to RDV, including transaminitis in 20% of children, bradycardia in 8%, and hypotension in 5%. AEs did not require discontinuation of RDV, except in one patient who developed premature ventricular contractions. The rate of AEs did not differ between patients with severe COVID-19 and those with mild-moderate COVID-19 but at high risk for severe disease. All but one patient were discharged within 23 days of admission, and no fatalities were recorded. Among high-risk patients with mild-moderate disease, only 2 (9%) progressed to the point of needing supplemental oxygen. Our data suggests that RDV is safe in children, with no reported serious AEs. However, the absence of a control group limits the extent to which conclusions can be drawn. RDV may contribute to clinical improvement, particularly in high-risk patients.

中文翻译：

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瑞德西韦治疗儿科急性 COVID-19 的不良反应：一项回顾性观察研究

尽管 2019 年冠状病毒病 (COVID-19) 在儿童中的严重程度往往较低，但它仍然可能导致严重疾病，特别是对于患有慢性疾病的儿童。虽然瑞德西韦 (RDV) 是许多国家为数不多的获批用于儿童 C​​OVID-19 的抗病毒治疗药物之一，但有关 RDV 在该人群中安全性的现有数据有限。为了弥补这一知识差距，一项涉及 65 名患者的多中心研究回顾性分析了年龄 <18 岁因严重 COVID-19（定义为 SpO2 < 94% 或需要补充氧气）而住院并接受至少一剂药物的患者的临床数据。 RDV。此外，该研究还包括 22 名患有轻度至中度 COVID-19 的患者，他们被认为有发展为严重疾病的高风险。19 名儿童 (29%) 经历了 RDV 引起的轻度至中度不良事件 (AE)，包括 20% 的儿童出现转氨酶升高、8% 的儿童出现心动过缓、5% 的儿童出现低血压。除一名出现室性早搏的患者外，AE 不需要停止 RDV。重症 COVID-19 患者与轻度至中度 COVID-19 但重症风险较高的患者之间的 AE 发生率没有差异。除一名患者外，所有患者均在入院 23 天内出院，无死亡病例。在患有轻中度疾病的高危患者中，只有 2 人（9%）进展到需要补充氧气的程度。我们的数据表明 RDV 对儿童是安全的，没有报告严重的 AE。然而，缺乏对照组限制了得出结论的程度。RDV 可能有助于临床改善，尤其是高危患者。