TY - JOUR
T1 - Compassionate use of remdesivir in children with severe covid-19
AU - Goldman, David L.
AU - Aldrich, Margaret L.
AU - Hagmann, Stefan H.F.
AU - Bamford, Alasdair
AU - Camacho-Gonzalez, Andres
AU - Lapadula, Giuseppe
AU - Lee, Philip
AU - Bonfanti, Paolo
AU - Carter, Christoph C.
AU - Zhao, Yang
AU - Telep, Laura
AU - Pikora, Cheryl
AU - Naik, Sarjita
AU - Marshall, Neal
AU - Katsarolis, Ioannis
AU - Das, Moupali
AU - DeZure, Adam
AU - Desai, Polly
AU - Cao, Huyen
AU - Chokkalingam, Anand P.
AU - Osinusi, Anu
AU - Brainard, Diana M.
AU - Méndez-Echevarría, Ana
N1 - Publisher Copyright:
© 2021 by the American Academy of Pediatrics.
PY - 2021/5/1
Y1 - 2021/5/1
N2 - 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 compassionateuse 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.
AB - 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 compassionateuse 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.
UR - http://www.scopus.com/inward/record.url?scp=85105258429&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85105258429&partnerID=8YFLogxK
U2 - 10.1542/peds.2020-047803
DO - 10.1542/peds.2020-047803
M3 - Article
C2 - 33883243
AN - SCOPUS:85105258429
SN - 0031-4005
VL - 147
JO - Pediatrics
JF - Pediatrics
IS - 5
M1 - e2020047803
ER -