Literature DB >> 33883243

Compassionate Use of Remdesivir in Children With Severe COVID-19.

David L Goldman1, Margaret L Aldrich1, Stefan H F Hagmann2, Alasdair Bamford3, Andres Camacho-Gonzalez4, Giuseppe Lapadula5, Philip Lee1, Paolo Bonfanti5, Christoph C Carter6, Yang Zhao7, Laura Telep7, Cheryl Pikora7, Sarjita Naik7, Neal Marshall7, Ioannis Katsarolis7, Moupali Das7, Adam DeZure7, Polly Desai7, Huyen Cao7, Anand P Chokkalingam7, Anu Osinusi7, Diana M Brainard7, Ana Méndez-Echevarría8.   

Abstract

OBJECTIVES: Remdesivir shortens time to recovery in adults with severe coronavirus disease 2019 (COVID-19), but its efficacy and safety in children are unknown. We describe outcomes in children with severe COVID-19 treated with remdesivir.
METHODS: Seventy-seven hospitalized patients <18 years old with confirmed severe acute respiratory syndrome coronavirus 2 infection received remdesivir through a compassionate-use program between March 21 and April 22, 2020. The intended remdesivir treatment course was 10 days (200 mg on day 1 and 100 mg daily subsequently for children ≥40 kg and 5 mg/kg on day 1 and 2.5 mg/kg daily subsequently for children <40 kg, given intravenously). Clinical data through 28 days of follow-up were collected.
RESULTS: Median age was 14 years (interquartile range 7-16, range <2 months to 17 years). Seventy-nine percent of patients had ≥1 comorbid condition. At baseline, 90% of children required supplemental oxygen and 51% required invasive ventilation. By day 28 of follow-up, 88% of patients had a decreased oxygen-support requirement, 83% recovered, and 73% were discharged. Among children requiring invasive ventilation at baseline, 90% were extubated, 80% recovered, and 67% were discharged. There were 4 deaths, of which 3 were attributed to COVID-19. Remdesivir was well tolerated, with a low incidence of serious adverse events (16%). Most adverse events were related to COVID-19 or comorbid conditions. Laboratory abnormalities, including elevations in transaminase levels, were common; 61% were grades 1 or 2.
CONCLUSIONS: Among 77 children treated with remdesivir for severe COVID-19, most recovered and the rate of serious adverse events was low.
Copyright © 2021 by the American Academy of Pediatrics.

Entities:  

Year:  2021        PMID: 33883243     DOI: 10.1542/peds.2020-047803

Source DB:  PubMed          Journal:  Pediatrics        ISSN: 0031-4005            Impact factor:   7.124


  20 in total

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