PMID- 38381231 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240224 IS - 2194-7791 (Print) IS - 2194-7791 (Electronic) IS - 2194-7791 (Linking) VI - 11 IP - 1 DP - 2024 Feb 21 TI - Adverse effects of remdesivir for the treatment of acute COVID-19 in the pediatric population: a retrospective observational study. PG - 2 LID - 10.1186/s40348-024-00175-9 [doi] LID - 2 AB - BACKGROUND: Although the severity of coronavirus disease 2019 (COVID-19) tends to be lower in children, it can still lead to severe illness, particularly among those with chronic medical conditions. While remdesivir (RDV) is one of the few approved antiviral treatments for COVID-19 in children in many countries, the available data on the safety of RDV in this population is limited. METHODS: To address this knowledge gap, a multicenter study involving 65 patients retrospectively analyzed the clinical data from individuals aged <18 who were hospitalized due to severe COVID-19 (defined as SpO(2) < 94% or requiring supplemental oxygen) and received at least one dose of RDV. Additionally, the study encompassed 22 patients with mild-moderate COVID-19 who were considered at high risk of developing severe disease. RESULTS: Nineteen children (29%) experienced mild-to-moderate adverse events (AEs) attributed to RDV, including transaminitis in 20% of children, bradycardia in 8%, and hypotension in 5%. AEs did not require discontinuation of RDV, except in one patient who developed premature ventricular contractions. The rate of AEs did not differ between patients with severe COVID-19 and those with mild-moderate COVID-19 but at high risk for severe disease. All but one patient were discharged within 23 days of admission, and no fatalities were recorded. Among high-risk patients with mild-moderate disease, only 2 (9%) progressed to the point of needing supplemental oxygen. CONCLUSIONS: Our data suggests that RDV is safe in children, with no reported serious AEs. However, the absence of a control group limits the extent to which conclusions can be drawn. RDV may contribute to clinical improvement, particularly in high-risk patients. CI - (c) 2024. The Author(s). FAU - Schulz, Abigail AU - Schulz A AD - University of Illinois College of Medicine at Peoria, 530 NE Glen Oak Avenue, North Building #6606, Peoria, IL, 61637, USA. FAU - Huynh, Natalie AU - Huynh N AD - Department of Pediatrics, University of Illinois College of Medicine at Peoria, 530 NE Glen Oak Avenue, North Building #6606, Peoria, IL, 61637, USA. FAU - Heger, Margaret AU - Heger M AD - Department of Pharmacy, OSF HealthCare Children's Hospital of Illinois, Peoria, IL, USA. FAU - Bakir, Mustafa AU - Bakir M AD - Department of Pediatrics, Division of Pediatric Infectious Diseases, University of Illinois College of Medicine at Peoria, 530 NE Glen Oak Avenue, North Building #6606, Peoria, IL, 61637, USA. mbakir@uic.edu. LA - eng PT - Journal Article DEP - 20240221 PL - Germany TA - Mol Cell Pediatr JT - Molecular and cellular pediatrics JID - 101660689 PMC - PMC10881938 OTO - NOTNLM OT - Adverse effects OT - Children OT - Remdesivir COIS- The authors declare no competing interests. EDAT- 2024/02/21 12:43 MHDA- 2024/02/21 12:44 PMCR- 2024/02/21 CRDT- 2024/02/21 11:09 PHST- 2023/11/22 00:00 [received] PHST- 2024/02/05 00:00 [accepted] PHST- 2024/02/21 12:44 [medline] PHST- 2024/02/21 12:43 [pubmed] PHST- 2024/02/21 11:09 [entrez] PHST- 2024/02/21 00:00 [pmc-release] AID - 10.1186/s40348-024-00175-9 [pii] AID - 175 [pii] AID - 10.1186/s40348-024-00175-9 [doi] PST - epublish SO - Mol Cell Pediatr. 2024 Feb 21;11(1):2. doi: 10.1186/s40348-024-00175-9.