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Compassionate use of remdesivir in children with COVID-19
Ana Méndez-Echevarría1, Antonio Pérez-Martínez2, Luis Gonzalez Del Valle3
1Paediatric Infectious Diseases Department, Translational Research Network in Paediatric Infectious Diseases (RITIP), La Paz University Hospital, Paseo de la Castellana 261, 28046, Madrid, Spain. amendezes@yahoo.es.
Insights
Remdesivir (RDV) treatment for pediatric COVID-19 showed promising results in a Spanish study. Most children experienced successful outcomes without adverse events, highlighting the need for clinical trials in this population.
Area of Science:
- Pediatric Infectious Diseases
- Critical Care Medicine
- Pharmacology
Background:
- Children with COVID-19 can experience severe disease and death.
- Remdesivir (RDV) shows promise in adults but has limited data in children.
- RDV is prescribed for critically ill children despite not being approved for those under 12.
Purpose of the Study:
- To evaluate the safety and efficacy of compassionate use Remdesivir (RDV) in pediatric patients with severe COVID-19.
- To report outcomes in a cohort of Spanish children treated with RDV during the early pandemic.
Main Methods:
- Nationwide multicenter observational study in Spain.
- Included eight pediatric patients with confirmed SARS-CoV-2 receiving RDV.
- Data collected on patient demographics, underlying conditions, and clinical outcomes.
Main Results:
- Six out of eight children required Pediatric Intensive Care Unit admission.
- No Remdesivir-related adverse outcomes were observed.
- Seven patients achieved successful clinical outcomes; one patient died due to complications after late RDV administration.
Conclusions:
- Remdesivir (RDV) demonstrated a favorable safety profile and positive clinical outcomes in this cohort of pediatric COVID-19 patients.
- Further clinical trials are essential to establish the safety, tolerability, efficacy, and pharmacokinetics of RDV in children.
- RDV may be an effective treatment option for severe pediatric COVID-19 cases.
Abstract:
Children represent a minority of total COVID-19 cases, but studies have reported severe disease and death in pediatric patients. Remdesivir (RDV) has recently demonstrated promising results in adults with COVID-19, but few data have been reported to date in children.A nationwide multicenter observational study was conducted on children with confirmed SARS-CoV-2 receiving compassionate treatment with RDV in Spain. Eight patients were included in the study, four infants and four older children [median age 5 years old; IQR 4 months-11.6 years old]. Half of them had complex underlying medical conditions, and the rest were mostly infants (3/4). Six out of eight children needed Pediatric Intensive Care Unit Admission. No RDV-related adverse outcomes were observed in our patients. Seven have reached successful clinical outcome, but one patient with serious clinical status died due to complications. However, she received RDV very late after the first COVID-19 symptom.Conclusions: In our cohort, most of the patients achieved successful clinical outcome, without observing adverse events. Clinical trials of RDV therapy for children with COVID-19 are urgently needed, to assess the safety, tolerability, efficacy, and pharmacokinetics of RDV in children, as this could be an effective treatment in severe cases. What is Known: • Remdesivir has not been approved to treat COVID-19 in children under 12 years old, although the drug is currently being prescribed in critically ill children. • Remdesivir has recently demonstrated promising results in adults with COVID-19, but few data have been reported to date in paediatric population. What is New: • We report a multicentre cohort of children with confirmed SARS-CoV-2 and severe COVID-19 disease receiving remdesivir during the first month of the pandemic in Spain. • No remdesivir-related adverse outcomes were observed in most of the cases. Seven patients reached successful clinical outcome, and one died due to complications (bacterial sepsis).
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