Phase 2/3 of Remdesivir in patients from birth to <18 with COVID-19 [COVID-19]
Research type
Research Study
Full title
A Phase 2/3 Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS 5734™) in Participants from Birth to < 18 Years of Age with COVID-19
IRAS ID
283977
Contact name
Akash Deep
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2020-001803-17
Duration of Study in the UK
0 years, 10 months, 15 days
Research summary
In December 2019, a new coronavirus emerged in China resulting in a novel infectious disease called COVID-19. This spread throughout the world quickly. As of 10April2020, more than 1.5 million cases and approximately 93,000 deaths have been confirmed. Although a minority of children show severe COVID-19, hospitalised paediatric patients have emerged. It’s been reported that of 73 % of paediatric patients with symptoms (fever, cough), 5.7% were hospitalised (compared to 10% of adults). A treatment for paediatric population with COVID-19 is urgently needed.\nThere’s no approved treatment for COVID-19. Antiviral drugs are being tested as potential treatments, including remdesivir (RDV). Remdesivir has shown to be generally safe and tolerable based on animal and human studies. It’s shown potent activity in the lab and in animals against COVID-19. \n\nThe purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of RDV in participants from birth to <18 years of age with COVID-19.\nThis study is sponsored by Gilead Sciences, Inc. Approximately 52 patients will participate worldwide with 8 patients in the UK. Participants will be enrolled into one of the below cohorts using an interactive web response system:\n\nPaediatric participants ≥28 days <18 years:\n• Cohort 1 – 200mg RDV IV day 1 followed by 100mg daily upto 10 days\n• Cohort 2-4 – 5mg/kg RDV IV day 1 followed by 2.5mg/kg daily upto 10 days\n\nTerm Neonatal participants 0 days to <28 days:\n• Cohort 5 – 5mg/kg RDV IV day 1 followed by 2.5mg/kg daily upto 10 days\n• Cohort 6 – dose to be determined\n\nPre-term Neonates and infants 0 days to <56 days:\n• Cohort 7 – dose to be determined\n\nThe study consists of a 2-day screening period, a 10-day treatment period and follow up visit 30-days after last dose. Assessments include physical exam, ECG, vital signs, laboratory tests, and respiratory status.
REC name
London - Hampstead Research Ethics Committee
REC reference
20/HRA/2774
Date of REC Opinion
14 Jul 2020
REC opinion
Further Information Favourable Opinion