PDF(Pubmed)
Abstract：
Currently there is a lack of randomized trial data examining the use of the antiviral nirmatrelvir/ritonavir in paediatric patients with SARS-CoV-2 infection. This target trial emulation study aims to address this gap by evaluating the use of nirmatrelvir/ritonavir in non-hospitalized paediatric patients aged 12-17 years with SARS-CoV-2 Omicron variant infection. Among paediatric patients diagnosed between 16th March 2022 and 5th February 2023, exposure was defined as outpatient nirmatrelvir/ritonavir treatment within 5 days of symptom onset or COVID-19 diagnosis. Primary outcome was 28 day all-cause mortality or all-cause hospitalization, while secondary outcomes were 28 day in-hospital disease progression, 28 day COVID-19-specific hospitalization, multisystem inflammatory syndrome in children (MIS-C), acute liver injury, acute renal failure, and acute respiratory distress syndrome. Overall, 49,378 eligible paediatric patients were included. Nirmatrelvir/ritonavir treatment was associated with reduced 28 day all-cause hospitalization (absolute risk reduction = 0.23%, 95%CI = 0.19%-0.31%; relative risk = 0.66, 95%CI = 0.56-0.71). No events of mortality, in-hospital disease progression, or adverse clinical outcomes were observed among nirmatrelvir/ritonavir users. The findings confirmed the effectiveness of nirmatrelvir/ritonavir in reducing all-cause hospitalization risk among non-hospitalized pediatric patients with SARS-CoV-2 Omicron variant infection.
摘要：
目前，缺乏随机试验数据来检查SARS-CoV-2感染的儿科患者中抗病毒尼马特雷韦/利托那韦的使用。这项目标试验仿真研究旨在通过评估nirmatrelvir/利托那韦在12-17岁的非住院儿科患者中的使用SARS-CoV-2Omicron变体感染来解决这一差距。在2022年3月16日至2023年2月5日期间诊断的儿科患者中，暴露被定义为在症状发作或COVID-19诊断后5天内接受门诊尼马特雷韦/利托那韦治疗。主要结果是28天全因死亡率或全因住院，而次要结局是28天的院内疾病进展，28天COVID-19特异性住院，儿童多系统炎症综合征（MIS-C），急性肝损伤，急性肾功能衰竭,和急性呼吸窘迫综合征。总的来说,包括49,378名合格的儿科患者。Nirmatrelvir/利托那韦治疗与减少28天全因住院相关（绝对风险降低=0.23%，95CI=0.19%-0.31%；相对危险度=0.66，95CI=0.56-0.71）。没有死亡事件，院内疾病进展，或在尼马特雷韦/利托那韦使用者中观察到不良临床结局.研究结果证实了nirmatrelvir/ritonavir在降低SARS-CoV-2Omicron变异感染非住院儿科患者全因住院风险方面的有效性。
