A Single-Centered Cohort Study on Favipiravir Safety and Efficacy in Pediatric Patients with COVID-19.
Adverse Drug Reaction
COVID-19
Effectiveness
Favipiravir
Pediatrics
Safety
Journal
Iranian journal of pharmaceutical research : IJPR
ISSN: 1726-6890
Titre abrégé: Iran J Pharm Res
Pays: Netherlands
ID NLM: 101208407
Informations de publication
Date de publication:
Dec 2022
Dec 2022
Historique:
received:
13
09
2021
revised:
27
02
2022
accepted:
04
04
2022
entrez:
30
1
2023
pubmed:
31
1
2023
medline:
31
1
2023
Statut:
epublish
Résumé
Coronavirus disease 2019 (COVID-19) affects the pediatric population. Due to limited data, this study aimed to evaluate the safety and efficacy of favipiravir in the hospitalized pediatric population diagnosed with COVID-19. 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). 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). 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.
Sections du résumé
Background
UNASSIGNED
Coronavirus disease 2019 (COVID-19) affects the pediatric population.
Objectives
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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.
Identifiants
pubmed: 36710991
doi: 10.5812/ijpr-127034
pmc: PMC9872546
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e127034Informations de copyright
Copyright © 2022, Author(s).
Déclaration de conflit d'intérêts
Conflict of Interests: The authors declare no conflict of interest.
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