Infectious Diseases Unit, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
PhD Course "Immunology, Molecular Medicine and Applied Biotechnology", University of Rome Tor Vergata, Rome, Italy.
Ital J Pediatr. 2024 Feb 27;50(1):32. doi: 10.1186/s13052-024-01606-z.
COVID-19 is generally milder in children than in adults, however severe infection has been described in some patients. Few data are available on use of Remdesivir (RDV) in children, as most clinical trials focused on adult patients. We report a multicenter study conducted in 10 Italian Hospitals to investigate the safety of RDV in children affected by COVID-19.
We collected the clinical data of children with COVID-19 treated with RDV between March 2020 and February 2022 in 10 Italian hospitals. Clinical data were compared according to a duration of RDV therapy more or less than 5 days. Linear regression model was used to determine the association of significant variables from the bivariate analysis to the duration of RDV therapy.
A total of 50 patients were included, with a median age of 12.8 years. Many patients had at least one comorbidity (78%), mostly obesity. Symptoms were fever (88%), cough (74%) and dyspnea (68%). Most patients were diagnosed with pneumonia of either viral and/or bacterial etiology. Blood test showed leukopenia in 66% and increased C-reactive protein (CRP) levels in 63% of cases. Thirty-six patients received RDV for 5 days, nine patients up to 10 days. Most children who received RDV longer were admitted to the PICU (67%). Treatment with RDV was well tolerated with rare side effects: bradycardia was recorded in 6% of cases, solved in less than 24 h after discontinuation. A mild elevation of transaminases was observed in 26% of cases, however for the 8%, it was still detected before the RDV administration. Therefore, in these cases, we could not establish if it was caused by COVID-19, RDV o both. Patients who received RDV for more than 5 days waited longer for its administration after pneumonia diagnosis. The presence of comorbidities and the duration of O2 administration significantly correlated with the duration of RDV therapy at the linear regression analysis.
Our experience indicates that RDV against SARS-CoV-2 is safe and well-tolerated in pediatric populations at high risk of developing severe COVID-19. Our data suggest that delaying RDV therapy after diagnosis of pneumonia may be associated with a longer duration of antiviral therapy, especially in patients with comorbidities.
COVID-19 在儿童中的症状通常比成人轻,但在一些患者中也有严重感染的描述。由于大多数临床试验都集中在成年患者身上,因此关于瑞德西韦(RDV)在儿童中的使用的数据很少。我们报告了一项在意大利 10 家医院进行的多中心研究,以调查 RDV 在 COVID-19 患儿中的安全性。
我们收集了 2020 年 3 月至 2022 年 2 月期间在意大利 10 家医院接受 RDV 治疗的 COVID-19 患儿的临床数据。根据 RDV 治疗时间是否超过 5 天,对临床数据进行了比较。线性回归模型用于确定从双变量分析中确定的显著变量与 RDV 治疗时间的关系。
共纳入 50 例患儿,中位年龄为 12.8 岁。大多数患儿至少有一种合并症(78%),主要是肥胖。症状包括发热(88%)、咳嗽(74%)和呼吸困难(68%)。大多数患儿被诊断为病毒性和/或细菌性病因引起的肺炎。血液检查显示 66%的患儿白细胞减少,63%的患儿 C 反应蛋白(CRP)水平升高。36 例患儿接受 RDV 治疗 5 天,9 例患儿接受 RDV 治疗 10 天。大多数接受 RDV 治疗时间较长的患儿被收入 PICU(67%)。RDV 治疗耐受性良好,不良反应罕见:6%的患儿出现心动过缓,停药后不到 24 小时即可缓解。26%的患儿出现轻度转氨酶升高,但在 8%的患儿中,在使用 RDV 前仍可检测到。因此,在这些病例中,我们无法确定这是由 COVID-19、RDV 还是两者共同引起的。接受 RDV 治疗时间超过 5 天的患儿在肺炎诊断后等待 RDV 治疗的时间更长。合并症的存在和氧气治疗的时间与线性回归分析中 RDV 治疗时间的长短显著相关。
我们的经验表明,在有发生严重 COVID-19 风险的高危儿童人群中,使用瑞德西韦(RDV)治疗 SARS-CoV-2 是安全且耐受良好的。我们的数据表明,肺炎诊断后延迟 RDV 治疗可能与抗病毒治疗时间延长有关,特别是在合并症患者中。