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A Single-Centered Cohort Study on Favipiravir Safety and Efficacy in Pediatric Patients with COVID-19
Sedigheh Rafiei Tabatabaei1, Omid Moradi2, Abdollah Karimi3
1Pediatric Infections Research Center, Research Institute for Children's Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Insights
Favipiravir treatment in hospitalized children with COVID-19 showed no benefits for ventilation needs or hospital stay duration. This antiviral drug increased adverse drug reactions in pediatric patients.
Area of Science:
- Pediatric Infectious Diseases
- Clinical Pharmacology
- COVID-19 Research
Background:
- Coronavirus disease 2019 (COVID-19) presents unique challenges in the pediatric population.
- Limited data exists on the efficacy and safety of antiviral treatments for pediatric COVID-19.
Purpose of the Study:
- To evaluate the safety and efficacy of favipiravir in hospitalized pediatric patients diagnosed with COVID-19.
- To assess the impact of favipiravir on clinical outcomes and adverse drug reactions in children.
Main Methods:
- Retrospective cohort study of pediatric patients (1-18 years) with COVID-19.
- Favipiravir administered at specific dosages for 7-14 days.
- Evaluated outcomes included need for mechanical ventilation, ICU admission, hospital stay duration, mortality, and adverse drug reactions.
Main Results:
- Favipiravir use (25 patients) did not significantly reduce the need for invasive mechanical ventilation compared to controls (P = 1.000).
- Patients receiving favipiravir had a significantly longer median hospital stay (P = 0.002).
- Adverse drug reactions like decreased appetite, hypotension, and chest pain were more frequent in the favipiravir group (P < 0.05).
Conclusions:
- Favipiravir administration in pediatric COVID-19 patients is linked to increased adverse drug reactions.
- The study found no positive impact of favipiravir on mechanical ventilation, hospital stay, or mortality.
- Further randomized controlled trials are recommended to definitively assess favipiravir's role in pediatric COVID-19 management.
Background:
Coronavirus disease 2019 (COVID-19) affects the pediatric population.
Objectives:
Due to limited data, this study aimed to evaluate the safety and efficacy of favipiravir in the hospitalized pediatric population diagnosed with COVID-19.
Methods:
The present retrospective cohort study was conducted on pediatric patients aged 1 - 18 years with a diagnosis of COVID-19 admitted to Mofid Children's Hospital, Tehran, Iran. Favipiravir was administrated at a dose of 60 mg/kg/day (max: 3200 mg/day) on the first day and then 23 mg/kg/day (max: 1200 mg/day) for 7 to 14 days. The patients were evaluated regarding the need for invasive mechanical ventilation, intensive care unit admission, duration of hospital stay, and mortality. Safety was measured by the occurrence of related adverse drug reactions (ADRs).
Results:
A total of 95 patients were included in the study. Favipiravir was administered to 25 patients. The need for invasive mechanical ventilation was reported in 4 (16.00%) and 11 (15.71%) patients in the favipiravir and control groups, respectively (P = 1.000). The median duration of hospital stays was significantly higher in patients who received favipiravir than in the controls (P = 0.002). No difference was observed in the mortality rate (P = 0.695). The ADRs, including decreased appetite, hypotension, and chest pain, were more prevalent in patients who received favipiravir than in the controls (P < 0.05).
Conclusions:
The administration of favipiravir in the pediatric population is associated with higher ADR occurrence with no positive effect on the need for invasive mechanical ventilation, hospital stay, and mortality. Further randomized controlled trials are necessary for better judgment.
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