Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir in Hospitalized Children with RSV

Launched by PENTA FOUNDATION · Mar 7, 2025

Keywords

ClinConnect Summary

The THAI-CARES RSV Study is a research trial designed to understand how safe and effective the medication Remdesivir is for young children under two years old who are hospitalized with a condition called respiratory syncytial virus (RSV). This virus can cause breathing problems, and in this study, researchers are looking to see if a five-day treatment with Remdesivir can help reduce the virus in the body and improve the children's health. To be part of this study, children must be hospitalized with symptoms of RSV, such as trouble breathing or low oxygen levels, and their RSV infection must be confirmed through specific tests.

To participate, parents or caregivers will need to provide consent, and the child should be at least 2.0 kg in weight and show signs of RSV illness within the last week. However, some children may not be eligible, such as very young preterm infants or those with certain other health conditions. While the study is not currently recruiting participants, it aims to find out not only how well Remdesivir works but also how well children tolerate the treatment. Families involved can expect close monitoring of the child's health during the trial to ensure their safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent from parents/caregivers
• • Aged 0 to \<2 years
• • Weighing at least 2.0 kg
• • Onset of RSV associated-symptoms within 1 week of screening
• • Confirmed\* with RSV infection (by rapid antigen test or RT PCR)
• * Hospitalized children fulfilling at least two of the following three RSV disease severity criteria:
• • Inadequate oral feeding
• • Inadequate oxygen saturation (peripheral capillary oxygen saturation \[SpO2\] \<95% on room air or requiring oxygen supplementation to maintain SpO2 ≥95%)
• • Signs of respiratory distress (respiratory rate of ≥60 breaths per min for children aged up to 1 year, or ≥40 breaths per min for those older than 1 year, or accessory respiratory muscles use \[subcostal, intercostal, or suprasternal retraction\], or both)
• Exclusion Criteria:
• • Preterm infants (gestational age at birth less than 37 weeks) who are aged \<56 days
• • Being hospitalized for other clinically relevant concurrent conditions (except for risk factors for severe RSV, e.g., cardiac disease, pulmonary disease, genetic disease, and prematurity)
• • Concurrent treatments with other agents with actual or possible direct antiviral activity against RSV \<24 hours prior to study drug dosing (e.g. ribavirin)
• • ALT or AST \> 5 × ULN
• • eGFR \<30 mL/min/1.73m2 using the Schwartz formula if aged ≥1 year; or if aged \<1 year based on a creatinine value cut off dependent on chronological age
• • Any major congenital renal anomaly if \<28 days
• • Apgar score \< 5 when last recorded if age \<24 hours
• • Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
• • On renal replacement therapies (e.g., intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy)
• • Any condition that, in the opinion of the site investigator, would make participation in the study unsafe for the child, or comprise the study objectives