Compassionate use of remdesivir in children with COVID-19

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Compassionate use of remdesivir in children with COVID-19 Ana Méndez-Echevarría 1 & Antonio Pérez-Martínez 2 & Luis Gonzalez del Valle 3 & María Fátima Ara 4 & Susana Melendo 5 & Marta Ruiz de Valbuena 6 & Jose Luis Vazquez-Martinez 7 & Antonio Morales-Martínez 8 & Agustín Remesal 9 & Kinga Amália Sándor-Bajusz 10 & Fernando Cabañas 11 & Cristina Calvo 1 Received: 30 May 2020 / Revised: 5 November 2020 / Accepted: 11 November 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020

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).

Communicated by Nicole Ritz * Ana Méndez-Echevarría [email protected] Antonio Pérez-Martínez [email protected] Luis Gonzalez del Valle [email protected] María Fátima Ara [email protected] Susana Melendo [email protected] Marta Ruiz de Valbuena [email protected]

Jose Luis Vazquez-Martinez [email protected] Antonio Morales-Martínez [email protected] Agustín Remesal [email protected] Kinga Amália Sándor-Bajusz [email protected] Fernando Cabañas fernando.cabanas@