Adverse effects of remdesivir for the treatment of acute COVID-19 in the pediatric population: a retrospective observational study.

IF 2.4 Q1 PEDIATRICS
Abigail Schulz, Natalie Huynh, Margaret Heger, Mustafa Bakir
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引用次数: 0

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

雷米替韦治疗儿童急性 COVID-19 的不良反应:一项回顾性观察研究。
背景:尽管冠状病毒病2019(COVID-19)在儿童中的严重程度往往较低,但它仍可能导致严重的疾病,尤其是那些患有慢性疾病的儿童。虽然雷米替韦(RDV)是许多国家批准的少数几种治疗儿童 COVID-19 的抗病毒药物之一,但有关 RDV 在这一人群中安全性的现有数据却很有限:为了填补这一知识空白,一项涉及 65 名患者的多中心研究回顾性分析了年龄在 2 岁以下(94% 或需要补充氧气)、至少接受过一次 RDV 治疗的患者的临床数据。此外,该研究还包括22名轻度-中度COVID-19患者,他们被认为具有发展成重症的高风险:19名儿童(29%)出现了由RDV引起的轻度至中度不良事件(AEs),其中20%的儿童出现转氨酶炎,8%的儿童出现心动过缓,5%的儿童出现低血压。除一名患者出现室性早搏外,其他不良反应均无需停用 RDV。重度 COVID-19 患者与轻度-中度 COVID-19 但重症风险较高的患者之间的 AEs 发生率没有差异。除一名患者外,所有患者均在入院后23天内出院,没有死亡记录。在患有轻中度疾病的高危患者中,只有2人(9%)病情恶化到需要补充氧气的地步:我们的数据表明,RDV 对儿童是安全的,没有严重不良反应的报道。结论:我们的数据表明,RDV 对儿童是安全的,没有出现严重不良反应的报道。然而,由于没有对照组,因此无法得出结论。RDV 可能有助于临床改善,尤其是在高危患者中。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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