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Tests treatment safety and results for Respiratory Syncytial Virus (RSV)
Official title Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV
ClinicalTrials.gov ID: NCT06873633
What this study is testing
What is Remdesivir?
Remdesivir is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for respiratory syncytial virus (rsv).
Also referred to as VEKLURY®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 2
You may be able to join if
- 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)
You likely can't join if
- 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...
- Concurrent treatments with other agents with actual or possible direct antiviral activity against RSV \<24 hours prior to study drug dosing (e.g...
- 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...
- Any major congenital renal anomaly if \<28 days
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bangkok, Thailand
- Chiang Mai, Thailand
- Chiang Rai, Thailand
- Khon Kaen, Thailand
- Lampang, Thailand
- Maha Sarakham, Thailand
- Samut Sakhon, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 days to 2 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkok, Thailand; Chiang Mai, Thailand; Chiang Rai, Thailand; Khon Kaen, Thailand; Lampang, Thailand; Maha Sarakham, Thailand and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.