Evaluation of the safety profile and therapeutic efficacy of remdesivir in children with SARS-CoV-2 infection - a single-center, retrospective, cohort study.

UNLABELLED

Despite 3.5 years of the SARS-CoV-2 pandemic, we still lack effective drugs against COVID-19. The first and most widely used drug, remdesivir, has not yet been shown to be effective in adults. Even less is known about its effectiveness in children. Therefore, the aim of this retrospective study was to evaluate the safety and efficacy of remdesivir in pediatric patients with COVID-19 hospitalized in one medical center. The medical records of 328 children with COVID-19 were analyzed. Analysis was performed on the subgroups of children treated and not treated with remdesivir. Clinical data on general health, course of COVID-19 and treatment received were analyzed. Remdesivir was administered to 64 children, 16 to treat severe or critical illness and 48 because of the presence of risk factors to prevent progression to severe COVID-19. In children with severe COVID-19, remdesivir did not reduce the mortality rate. However, in patients with milder disease and risk factors, the drug significantly reduced the risk of progression to severe disease. Among adverse events, only mild aminotransferase elevations were observed in 4 patients, but none of these required discontinuation of treatment.

CONCLUSIONS

Remdesivir is a safe treatment option for children with COVID-19. However, the efficacy of this therapy is still uncertain. It appears that in children with asymptomatic to moderate COVID-19 and risk factors for severe disease, remdesivir could be an effective method of prophylaxis. However, its efficacy in controlling severe disease is questionable and requires further study.

WHAT IS KNOWN

• There are still no effective drugs to combat COVID-19, and the efficacy of the widely used remdesivir in adults is controversial. • All recommendations and guidelines on the use of remdesivir in the pediatric population are based mainly on clinical trials in adults.

WHAT IS NEW

• Remdesivir is a safe treatment for COVID-19 in the pediatric population. • In children with asymptomatic to moderate COVID-19 and risk factors for severe disease, remdesivir could be an effective drug to prevent disease progression. However, its efficacy in treating severe disease in children needs further exploration.