Paediatric Infectious Diseases Department, Translational Research Network in Paediatric Infectious Diseases (RITIP), La Paz University Hospital, Paseo de la Castellana 261, 28046, Madrid, Spain.
Paediatric Hemato-Oncology Department, Translational Research in Pediatric Oncology, Hematopoietic Transplantation and Cell Therapy, La Paz University Hospital, La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.
Eur J Pediatr. 2021 Apr;180(4):1317-1322. doi: 10.1007/s00431-020-03876-1. Epub 2020 Nov 16.
Children represent a minority of total COVID-19 cases, but studies have reported severe disease and death in pediatric patients. Remdesivir (RDV) has recently demonstrated promising results in adults with COVID-19, but few data have been reported to date in children.A nationwide multicenter observational study was conducted on children with confirmed SARS-CoV-2 receiving compassionate treatment with RDV in Spain. Eight patients were included in the study, four infants and four older children [median age 5 years old; IQR 4 months-11.6 years old]. Half of them had complex underlying medical conditions, and the rest were mostly infants (3/4). Six out of eight children needed Pediatric Intensive Care Unit Admission. No RDV-related adverse outcomes were observed in our patients. Seven have reached successful clinical outcome, but one patient with serious clinical status died due to complications. However, she received RDV very late after the first COVID-19 symptom.Conclusions: In our cohort, most of the patients achieved successful clinical outcome, without observing adverse events. Clinical trials of RDV therapy for children with COVID-19 are urgently needed, to assess the safety, tolerability, efficacy, and pharmacokinetics of RDV in children, as this could be an effective treatment in severe cases. What is Known: • Remdesivir has not been approved to treat COVID-19 in children under 12 years old, although the drug is currently being prescribed in critically ill children. • Remdesivir has recently demonstrated promising results in adults with COVID-19, but few data have been reported to date in paediatric population. What is New: • We report a multicentre cohort of children with confirmed SARS-CoV-2 and severe COVID-19 disease receiving remdesivir during the first month of the pandemic in Spain. • No remdesivir-related adverse outcomes were observed in most of the cases. Seven patients reached successful clinical outcome, and one died due to complications (bacterial sepsis).
儿童在 COVID-19 总病例中占少数，但已有研究报道儿科患者中出现严重疾病和死亡病例。瑞德西韦（RDV）最近在 COVID-19 成人患者中显示出有前景的结果，但迄今为止，在儿童中报告的数据很少。一项针对在西班牙接受同情治疗用瑞德西韦治疗的确诊 SARS-CoV-2 儿童的全国多中心观察性研究进行了研究。该研究纳入了 8 名患儿，其中 4 名婴儿和 4 名大龄儿童[中位年龄 5 岁；四分位距 4 个月-11.6 岁]。其中一半患儿有复杂的基础医学疾病，其余患儿大多为婴儿（3/4）。8 名患儿中有 6 名需要入住儿科重症监护病房。我们的患者未观察到与 RDV 相关的不良结局。7 名患儿达到了成功的临床结局，但 1 名病情严重的患儿因并发症死亡。然而，她在 COVID-19 症状首次出现后非常晚才接受 RDV 治疗。结论：在我们的队列中，大多数患儿取得了成功的临床结局，未观察到不良事件。急需对 COVID-19 儿童瑞德西韦治疗进行临床试验，以评估 RDV 在儿童中的安全性、耐受性、疗效和药代动力学，因为该药在重症病例中可能是一种有效的治疗方法。已知：• 尽管该药物目前正在危重症儿童中使用，但瑞德西韦尚未获准用于 12 岁以下儿童 COVID-19 的治疗。• 瑞德西韦最近在 COVID-19 成人患者中显示出有前景的结果，但迄今为止，在儿科人群中报告的数据很少。新发现：• 我们报告了西班牙大流行期间第一个月接受瑞德西韦治疗的确诊 SARS-CoV-2 且患有严重 COVID-19 疾病的儿童的多中心队列。• 在大多数情况下，未观察到与瑞德西韦相关的不良结局。7 名患儿达到了成功的临床结局，1 名患儿因并发症（细菌性败血症）死亡。
