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Compassionate Use of Remdesivir in Children With Severe COVID-19
David L Goldman1, Margaret L Aldrich1, Stefan H F Hagmann2
1Children's Hospital at Montefiore, New York, New York.
Insights
Remdesivir treatment in children with severe COVID-19 led to recovery in most patients. The antiviral medication was well tolerated, with a low incidence of serious adverse events observed in this pediatric study.
Area of Science:
- Pediatric Infectious Diseases
- Antiviral Therapeutics
- Critical Care Medicine
Background:
- Severe coronavirus disease 2019 (COVID-19) poses a significant threat to children.
- The efficacy and safety of remdesivir in pediatric populations with severe COVID-19 were previously unknown.
- Adult studies indicated remdesivir shortens recovery time in severe COVID-19.
Purpose of the Study:
- To evaluate the efficacy and safety of remdesivir in children with severe COVID-19.
- To describe clinical outcomes in pediatric patients treated with remdesivir.
- To assess the tolerability and adverse event profile of remdesivir in children.
Main Methods:
- A compassionate-use program administered remdesivir to 77 hospitalized children (<18 years) with confirmed severe COVID-19.
- Patients received a 10-day intravenous course of remdesivir, with dosing adjusted for weight.
- Clinical data were collected for 28 days post-treatment to assess outcomes and adverse events.
Main Results:
- Of 77 pediatric patients, 83% recovered and 73% were discharged by day 28.
- Among those requiring invasive ventilation, 90% were extubated, 80% recovered, and 67% were discharged.
- Remdesivir was well tolerated, with 16% experiencing serious adverse events; laboratory abnormalities were common but mostly mild.
Conclusions:
- Remdesivir treatment in children with severe COVID-19 demonstrated a high recovery rate.
- The antiviral medication was generally well tolerated in the pediatric population.
- The study supports the use of remdesivir for severe COVID-19 in children, with careful monitoring for potential adverse events.
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.
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