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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.
  • Goldman DL; Children's Hospital at Montefiore, New York, New York.
  • Aldrich ML; Children's Hospital at Montefiore, New York, New York.
  • Hagmann SHF; Steven and Alexandra Cohen Children's Medical Center, Northwell Health, New York, New York.
  • Bamford A; Great Ormond Street Hospital for Children National Health Service Foundation Trust, London, United Kingdom.
  • Camacho-Gonzalez A; Emory University and Children's Healthcare of Atlanta, Atlanta, Georgia.
  • Lapadula G; University of Milan-Bicocca, Monza, Italy.
  • Lee P; Children's Hospital at Montefiore, New York, New York.
  • Bonfanti P; University of Milan-Bicocca, Monza, Italy.
  • Carter CC; Gilead Sciences Inc, Foster City, California; and christoph.carter7@gilead.com.
  • Zhao Y; Gilead Sciences Inc, Foster City, California; and.
  • Telep L; Gilead Sciences Inc, Foster City, California; and.
  • Pikora C; Gilead Sciences Inc, Foster City, California; and.
  • Naik S; Gilead Sciences Inc, Foster City, California; and.
  • Marshall N; Gilead Sciences Inc, Foster City, California; and.
  • Katsarolis I; Gilead Sciences Inc, Foster City, California; and.
  • Das M; Gilead Sciences Inc, Foster City, California; and.
  • DeZure A; Gilead Sciences Inc, Foster City, California; and.
  • Desai P; Gilead Sciences Inc, Foster City, California; and.
  • Cao H; Gilead Sciences Inc, Foster City, California; and.
  • Chokkalingam AP; Gilead Sciences Inc, Foster City, California; and.
  • Osinusi A; Gilead Sciences Inc, Foster City, California; and.
  • Brainard DM; Gilead Sciences Inc, Foster City, California; and.
  • Méndez-Echevarría A; Hospital La Paz, Madrid, Spain.
Pediatrics ; 147(5)2021 05.
Article in English | MEDLINE | ID: covidwho-1197419
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Adenosine Monophosphate / Alanine / COVID-19 Drug Treatment Type of study: Cohort study / Diagnostic study / Observational study / Prognostic study / Randomized controlled trials Limits: Adolescent / Child / Child, preschool / Female / Humans / Infant / Male Language: English Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Adenosine Monophosphate / Alanine / COVID-19 Drug Treatment Type of study: Cohort study / Diagnostic study / Observational study / Prognostic study / Randomized controlled trials Limits: Adolescent / Child / Child, preschool / Female / Humans / Infant / Male Language: English Year: 2021 Document Type: Article