tetano
Editor, Senior Moderator
Pediatrics
. 2021 Apr 21;e2020047803.
doi: 10.1542/peds.2020-047803. Online ahead of print.
Compassionate Use of Remdesivir in Children With Severe COVID-19
David L Goldman[SUP] 1 [/SUP], Margaret L Aldrich[SUP] 1 [/SUP], Stefan H F Hagmann[SUP] 2 [/SUP], Alasdair Bamford[SUP] 3 [/SUP], Andres Camacho-Gonzalez[SUP] 4 [/SUP], Giuseppe Lapadula[SUP] 5 [/SUP], Philip Lee[SUP] 1 [/SUP], Paolo Bonfanti[SUP] 5 [/SUP], Christoph C Carter[SUP] 6 [/SUP], Yang Zhao[SUP] 7 [/SUP], Laura Telep[SUP] 7 [/SUP], Cheryl Pikora[SUP] 7 [/SUP], Sarjita Naik[SUP] 7 [/SUP], Neal Marshall[SUP] 7 [/SUP], Ioannis Katsarolis[SUP] 7 [/SUP], Moupali Das[SUP] 7 [/SUP], Adam DeZure[SUP] 7 [/SUP], Polly Desai[SUP] 7 [/SUP], Huyen Cao[SUP] 7 [/SUP], Anand P Chokkalingam[SUP] 7 [/SUP], Anu Osinusi[SUP] 7 [/SUP], Diana M Brainard[SUP] 7 [/SUP], Ana M?ndez-Echevarr?a[SUP] 8 [/SUP]
Affiliations
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.
. 2021 Apr 21;e2020047803.
doi: 10.1542/peds.2020-047803. Online ahead of print.
Compassionate Use of Remdesivir in Children With Severe COVID-19
David L Goldman[SUP] 1 [/SUP], Margaret L Aldrich[SUP] 1 [/SUP], Stefan H F Hagmann[SUP] 2 [/SUP], Alasdair Bamford[SUP] 3 [/SUP], Andres Camacho-Gonzalez[SUP] 4 [/SUP], Giuseppe Lapadula[SUP] 5 [/SUP], Philip Lee[SUP] 1 [/SUP], Paolo Bonfanti[SUP] 5 [/SUP], Christoph C Carter[SUP] 6 [/SUP], Yang Zhao[SUP] 7 [/SUP], Laura Telep[SUP] 7 [/SUP], Cheryl Pikora[SUP] 7 [/SUP], Sarjita Naik[SUP] 7 [/SUP], Neal Marshall[SUP] 7 [/SUP], Ioannis Katsarolis[SUP] 7 [/SUP], Moupali Das[SUP] 7 [/SUP], Adam DeZure[SUP] 7 [/SUP], Polly Desai[SUP] 7 [/SUP], Huyen Cao[SUP] 7 [/SUP], Anand P Chokkalingam[SUP] 7 [/SUP], Anu Osinusi[SUP] 7 [/SUP], Diana M Brainard[SUP] 7 [/SUP], Ana M?ndez-Echevarr?a[SUP] 8 [/SUP]
Affiliations
- PMID: 33883243
- DOI: 10.1542/peds.2020-047803
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.