Compassionate Use of Remdesivir in Children With Severe COVID-19

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.

Analysis of Critical COVID-19 Cases Among Children in Korea

“… 30 Reported adverse effects of remdesivir include nausea, vomiting, and transaminase elevations and in a study of compassionate use in children, remdesivir was well tolerated, with a low incidence of serious adverse events. 39 …”

A Case Report for Severe COVID-19 in a 9-Year-Old Child Treated with Remdesivir and Dexamethasone

“…2 Remdesivir has not been evaluated in clinical trials for children, and there have been no results from systemic evaluations of pharmacokinetics, efficacy, or toxicity in younger children, although studies are ongoing (NCT04431453). 2 Recently, a report of the compassionate use of remdesivir in children with severe COVID-19 was published by Goldman et al 25 The report showed that among 77 children treated with remdesivir for severe COVID-19, most recovered and the rate of serious adverse events was low. 25 Remdesivir may cause adverse events such as transaminase elevations, hypersensitivity reactions and bradycardia.…”

“…2 Recently, a report of the compassionate use of remdesivir in children with severe COVID-19 was published by Goldman et al 25 The report showed that among 77 children treated with remdesivir for severe COVID-19, most recovered and the rate of serious adverse events was low. 25 Remdesivir may cause adverse events such as transaminase elevations, hypersensitivity reactions and bradycardia. 12 Except the report by Goldman et al, 25 there are only a few case reports of children with COVID-19 treated with remdesivir.…”

“… 25 Remdesivir may cause adverse events such as transaminase elevations, hypersensitivity reactions and bradycardia. 12 Except the report by Goldman et al, 25 there are only a few case reports of children with COVID-19 treated with remdesivir. 26 27 28 29 Remdesivir became available for use in July 2020 in Korea.…”

Remdesivir, Sinus Bradycardia and Therapeutic Drug Monitoring in Children With Severe COVID-19

“…All children received 5 mg/kg RDV on the first day, followed by 2.5 mg/kg as considered to be safe and effective for compassionate use in children with severe COVID-19. 4 …”