Five-day remdesivir treatment for hospitalized infants with RSV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Lampang Hospital
  Lampang, Thailand Recruiting
• Mahasarakham Hospital
  Maha Sarakham, Thailand 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.