What is Remdesivir studying for respiratory syncytial virus (RSV) infection in children?

Remdesivir is being studied to assess its safety, antiviral activity, and how well it is accepted in children under two years hospitalized with RSV. The trial aims to understand if Remdesivir can reduce the virus in this young population. This study is sponsored by the PENTA Foundation and helps address the need for effective RSV treatments in infants and young children.

Who may be eligible for this RSV clinical trial?

Children under 2 years old who weigh at least 2 kilograms and have confirmed RSV infection by rapid antigen test or RT-PCR may be eligible. They must be hospitalized with RSV symptoms starting within the last week and meet certain disease severity criteria. The trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this RSV clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are usually not covered by the study. Participants and families should plan accordingly for any additional costs.

Actively Recruiting

Phase 2

Age: 0Days - 2Years

All Genders

ID06873633

Phase II Study of Remdesivir VEKLURY4 Safety and Antiviral Effects in Hospitalized Children Under 2 Years With RSV Lower Respiratory Infection

Led by PENTA Foundation · Updated on 2025-07-23

120

Participants Needed

Research Sites

35 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating Remdesivir VEKLURY4 in children under two years old who are hospitalized with confirmed respiratory syncytial virus RSV infection. This Phase II, open-label, randomized controlled trial aims to assess the safety, antiviral activity, and acceptability of a five-day course of Remdesivir compared to standard care. The study focuses on how well the treatment reduces RSV replication and its safety profile in this young patient group. Participants will be randomly assigned to one of two groups one group will receive standard care alone, which may include oxygen therapy, bronchodilators, intravenous fluids, steroids, antibiotics, and treatment for underlying diseases as needed. The other group will receive Remdesivir by intravenous infusion every 24 hours for five consecutive days in addition to the standard care. Treatment doses will be based on the childs weight at the time of randomization. The study will enroll about 120 children and follow them throughout hospitalization plus a final visit 7 to 10 days after Day 6. Throughout the study, researchers will monitor participants for safety and tolerability of Remdesivir, measure RSV viral load, and assess the treatments effectiveness over one week. Assessments will include clinical observations, laboratory tests, and evaluations of respiratory status. The follow-up after hospitalization will help determine the lasting effects and acceptability of the treatment in this population.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0Days - 2Years

All Genders

Eligibility Criteria

You may qualify if you...

Signed informed consent from parents or caregivers
Age 0 to less than 2 years
Weight at least 2.0 kg
Onset of RSV symptoms within 1 week before screening
Confirmed RSV infection by rapid antigen test or RT-PCR
Hospitalized with at least two of the following: inadequate oral feeding, low oxygen saturation (<95% on room air or needing oxygen to keep ≥95%), signs of respiratory distress (high respiratory rate or use of accessory muscles)

You will not qualify if you...

Preterm infants born before 37 weeks gestation who are under 56 days old
Hospitalized for other clinically relevant conditions except risk factors for severe RSV
Use of other antiviral treatments against RSV within 24 hours before study drug dosing
Elevated liver enzymes (ALT or AST > 5 times normal limit)
Low kidney function (eGFR <30 mL/min/1.73m2)
Major congenital kidney anomalies if younger than 28 days
Low Apgar score (<5) if under 24 hours old
Known allergy to Remdesivir or its components
Receiving renal replacement therapy
Any condition making participation unsafe or interfering with study goals as judged by the investigator

Research Team

Federica D'Ambrosio

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Phase II Study of Remdesivir VEKLURY4 Safety and Antiviral Effects in Hospitalized Children Under 2 Years With RSV Lower Respiratory Infection

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria