Background: Paxlovid is recognized as an effective medication in preventing the progression of coronavirus disease of 2019 (COVID-19) to severe form in adults; however, its efficacy has remained unknown in pediatric cases. This study aimed to analyze the feasibility, safety, and efficacy of Paxlovid treatment in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected children aged 6-14 years. Methods: We conducted a cohort study based on prospectively collected clinical data. We recruited 5 pediatric cases with underlying diseases treated with Paxlovid from 7 April 2022 to 26 May 2022 and 30 age-matched patients with underlying diseases who were not treated with Paxlovid as controls. The safety and efficacy of Paxlovid were primarily assessed by inter-group comparisons. Results: Of the 5 Paxlovid-treated cases, including 1 male and 4 females, 3 and 2 cases were mildly and moderately ill, respectively. The underlying diseases included congenital heart defects, cerebral palsy, Down syndrome, and leukemia. Only 1 patient had received 1 dose of an inactivated SARS-CoV-2 vaccine. Paxlovid was initiated within 5 days after the onset of symptoms in all cases. Comedications were used in 2 cases. In the safety analyses, after Paxlovid initiation, 1 patient had transient diarrhea, and 1 patient had transiently elevated liver enzymes [alanine transaminase (ALT), 125 U/L; aspartate transaminase (AST), 83 U/L; normal range, <40 U/L]. In the efficacy analyses, all 5 Paxlovid-treated cases recovered, with the respective viral shedding times of 11, 4, 10, 9, and 9 days. Compared with age-matched controls, the viral shedding times were not significantly different between groups.Conclusions: Based on the current small sample size study, Paxlovid is a feasible option for treating SARS-CoV-2-infected children aged 6-14 years with underlying diseases. However, the safety and efficacy of Paxlovid warrant further large-scale studies.

Background Gut microbiota alterations have been implicated in the pathogenesis of coronavirus disease 2019 (COVID-19). This study aimed to explore gut microbiota changes in a prospective cohort of COVID-19 children and their asymptomatic caregivers infected with the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) Omicron variant. Methods A total of 186 participants, including 59 COVID-19 children, 50 asymptomatic adult caregivers, 52 healthy children (HC), and 25 healthy adults (HA), were recruited between 15 April and 31 May 2022. The gut microbiota composition was determined by 16S rRNA gene sequencing in fecal samples collected from the participants. Gut microbiota functional profiling was performed by using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt) software. Results The gut microbiota analysis of beta diversity revealed that the fecal microbial community of COVID-19 children remained far distantly related to HC. The relative abundances of the phyla Actinobacteria and Firmicutes were decreased, whereas Bacteroidetes , Proteobacteria , and Verrucomicrobiota were increased in COVID-19 children. Feces from COVID-19 children exhibited notably lower abundances of the genera Blautia , Bifidobacterium , Fusicatenibacter , Streptococcus , and Romboutsia and higher abundances of the genera Prevotella , Lachnoclostridium , Escherichia-Shigella , and Bacteroides than those from HC. The enterotype distributions of COVID-19 children were characterized by a high prevalence of enterotype Bacteroides . Similar changes in gut microbiota compositions were observed in asymptomatic caregivers. Furthermore, the microbial metabolic activities of KEGG (Kyoto Encyclopedia of Genes and Genomes) and COG (cluster of orthologous groups of proteins) pathways were perturbed in feces from subjects infected with the SARS-CoV-2 Omicron variant. Conclusion Our data reveal altered gut microbiota compositions in both COVID-19 children and their asymptomatic caregivers infected with the SARS-CoV-2 Omicron variant, which further implicates the critical role of gut microbiota in COVID-19 pathogenesis. Supplementary Information The online version contains supplementary material available at 10.1007/s12519-022-00659-6.

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Objective: To explore the impact of paternal age on the risk of congenital anomalies and birth outcomes in U.S. infants born between 2016 and 2021.Methods: This retrospective cohort study was based on live births in the National Vital Statistics System database between 2016 and 2021. All newborns were divided into 4 groups based on paternal age (<25, 25-34, 35-44, and >44 years old groups) and using 25-34 years groups as reference. The primary outcomes were congenital anomalies including structural anomalies, and chromosome anomalies, while the secondary outcomes included preterm birth, low birth weight, severe neonatal perinatal asphyxia, admission to neonatal intensive care units, etc. The association between paternal age and outcomes was detected by multivariable logistic analysis.Results: After the exclusion process, a total of 17,764,695 live births were included in the nal analyses. After adjustment for confounding factors, compared with the paternal age of 25-34 years group, advanced paternal age of more than 44 years was associated with increased odds of congenital anomalies (aOR=1.17, 95%CI 1.12-1.21), mainly for the chromosomal anomalies (aOR=1.59, 95%CI 1.40-1.78) but not the structure anomalies (aOR=1.03, 95%CI 0.97-1.09). Advanced paternal age also increased the risk of preterm delivery, low birth weight, and admission to NICU in their infants.Conclusion: Advanced paternal age increases the risk of congenital anomalies in their offspring, especially chromosomal anomalies, which implies more intensive prenatal or pre-conceptional investigation, including genetic tests, should be taken in the high-risk paternal populations. What Is KnownIt has been documented that the mean paternal age worldwide has been increasing for the past half century, and research has been conducted on the risks associated with birth outcomes such as premature, low birth weight, etc., for older fathers. Despite this, there is limited data on paternal age and congenital abnormalities, and some researchers' conclusions are contradictory. What is NewInfants of fathers aged 44 years and above were more likely to have congenital anomalies, especially chromosomal anomalies. They were also more likely to be born preterm with lower birth weight and a high chance of being admitted to the NICU. It'd be better for couples to take considerate prenatal or preconceptional investigation with paternal age >44 years.