The feasibility, safety, and efficacy of Paxlovid treatment in SARS-CoV-2 infected children aged 6-14 years: a cohort study

Background Paxlovid, as an effective medication in preventing COVID-19 progression to severe form in adult, the efficacy was unknown in pediatric cases. This current study aims to analyze the feasibility, safety, and efficacy of Paxlovid Treatment in SARS-CoV-2 infected children aged 6-14 Years. Methods: This study is a cohort study based on prospectively collected clinical data. Five pediatric cases with underlying diseases treated with Paxlovid from April 7, 2022, to May 26, 2022, were recruited with 30 age-matched patients with underlying diseases and 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, 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, leukemia, etc. Only 1 patient gained 1 dose of 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. For safety analyses, after Paxlovid initiation, one patient had transient diarrhea, and one patient had transiently elevated liver transaminase (ALT 125 U/L, AST 83 U/L; normal range <40 U/L). For efficacy analyses, all 5 Paxlovid-treated cases recovered with the viral shedding times of 11, 4, 10, 9, and 9 days respectively. 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.