RECRUITINGPhase 2INTERVENTIONAL

Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV

A Phase II Study to Evaluate the Safety, Pharmacokinetics, Antiviral Activity and Acceptability of Remdesivir (VEKLURY®) in Hospitalized Children Aged 0 to Less Than 2 Years With Respiratory Syncytial Virus (RSV)-Associated Lower Respiratory Tract Infection.

About This Trial

THAI-CARES RSV Study is a Phase II, open-label, multicenter, randomized controlled trial with a two-arm, parallel-group design. The study aims to assess the safety, efficacy, and acceptability of a five-day course of Remdesivir (VEKLURY®) in children under two years of age who are hospitalized with confirmed respiratory syncytial virus (RSV) infection, as determined by either a rapid antigen test or RT-PCR. The primary objectives include evaluating the treatment's safety profile, its ability to significantly reduce RSV replication, and its overall acceptance in this patient population.

Who May Be Eligible (Plain English)

Who May Qualify: - Signed willing to sign a consent form 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) Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Remdesivir

Remdesivir (RDV) has shown potent antiviral activity against RSV A in an animal model. Remdesivir has been also shown to be a safe treatment option in pediatric patients hospitalized with COVID-19. Based on previous clinical evidence and preclinical data, to address the unmet medical need for safe and effective RSV therapy, this study is being conducted to investigate remdesivir in infants and children (aged 0 days to \<2 years) as a potential treatment for RSV infection.

Locations (8)

Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University (CE-PID)

Bangkok, Thailand

Nakornping Hospital

Chiang Mai, Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Chiangrai Prachanukroh Hospital

Chiang Rai, Thailand

Khon Kaen Hospital

Khon Kaen, Thailand

Lampang Hospital

Lampang, Thailand

Mahasarakham Hospital

Maha Sarakham, Thailand

Samut Sakhon Hospital

Samut Sakhon, Thailand