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

Goldman, David L; Aldrich, Margaret L; Hagmann, Stefan H F; Bamford, Alasdair; Camacho-Gonzalez, Andres; Lapadula, Giuseppe; Lee, Philip; Bonfanti, Paolo; Carter, Christoph C; Zhao, Yang; Telep, Laura; Pikora, Cheryl; Naik, Sarjita; Marshall, Neal; Katsarolis, Ioannis; Das, Moupali; DeZure, Adam; Desai, Polly; Cao, Huyen; Chokkalingam, Anand P; Osinusi, Anu; Brainard, Diana M; Méndez-Echevarría, Ana

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.