Five-day remdesivir treatment for hospitalized infants 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.
PHASE2 · PENTA Foundation · NCT06873633
This trial tests a five-day intravenous course of remdesivir in hospitalized children under two with confirmed RSV to see if it is safe and lowers the amount of virus.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 0 Days to 2 Years |
| Sex | All |
| Sponsor | PENTA Foundation (network) |
| Locations | 8 sites (Bangkok and 7 other locations) |
| Trial ID | NCT06873633 on ClinicalTrials.gov |
What this trial studies
This Phase II, open-label, randomized (1:1), two-arm trial will enroll about 120 children under two years hospitalized with confirmed RSV. Participants will receive either standard care alone or standard care plus daily IV remdesivir for five consecutive days and will be followed through hospitalization and for a final visit 7–10 days after treatment. The study will collect safety data, measure viral levels to determine antiviral activity, and record acceptability and clinical outcomes. Randomization and multiple hospital sites aim to provide comparative data on remdesivir added to current care in this age group.
Who should consider this trial
Good fit: Ideal candidates are hospitalized children aged 0 to under 2 years who weigh at least 2.0 kg, have symptom onset within seven days, a confirmed RSV test, and meet at least two predefined severity criteria like poor feeding, low oxygenation, or respiratory distress.
Not a fit: Children not likely to benefit include those with mild RSV who are not hospitalized, older children, certain very preterm infants under 56 days of age, or those hospitalized primarily for other unrelated conditions.
Why it matters
Potential benefit: If successful, the treatment could reduce viral levels and shorten or lessen the severity of RSV illness in hospitalized young children.
How similar studies have performed: Using remdesivir specifically for RSV in young children is relatively novel, with limited pediatric RSV data although remdesivir has demonstrated antiviral activity against similar respiratory viruses in other settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bangkok and 7 other locations
- Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University (CE-PID) — Bangkok, Thailand (RECRUITING)
- Nakornping Hospital — Chiang Mai, Thailand (RECRUITING)
- Maharaj Nakorn Chiang Mai Hospital — Chiang Mai, Thailand (RECRUITING)
- Chiangrai Prachanukroh Hospital — Chiang Rai, Thailand (RECRUITING)
- Khon Kaen Hospital — Khon Kaen, Thailand (NOT_YET_RECRUITING)
- Lampang Hospital — Lampang, Thailand (RECRUITING)
- Mahasarakham Hospital — Maha Sarakham, Thailand (RECRUITING)
- Samut Sakhon Hospital — Samut Sakhon, Thailand (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Tim R Cressey — AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University
- Study coordinator: Federica D'Ambrosio
- Email: federica.dambrosio@pentafoundation.org
- Phone: +39 049 716 9848
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Syncytial Virus, respiration disorders, RSV infection, Respiratory Syncytial Virus Hospitalizations