Compassionate Use of Remdesivir in Children With Severe COVID-19

作者：David L. Goldman, Margaret Aldrich, Stefan Hagmann, Alasdair Bamford, Andrés Camacho-González, Giuseppe Lapadula, Philip Lee, Paolo Bonfanti, Christoph C Carter, Yang Zhao, Laura Telep, Cheryl Pikora, Sarjita Naik, Neal Marshall, Ioannis Katsarolis, Moupali Das, Adam DeZure, Polly Desai, Huyen Cao, Anand P. Chokkalingam, Anu Osinusi, Diana M. Brainard, Ana Méndez‐Echevarría · 发表于：PEDIATRICS · 年份：2021 · DOI：10.1542/peds.2020-047803 · 被引用次数：104 · 研究领域：COVID-19 Clinical Research Studies、Respiratory Support and Mechanisms、Pharmacological Receptor Mechanisms and Effects

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 tran...