Respiratory Syncytial Virus (RSV)Phase 2THAI-CARES RSVNCT06873633
Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV
A Phase 2 study testing Remdesivir in people with Respiratory Syncytial Virus (RSV), run by PENTA Foundation at 8 sites in Thailand.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 days to 2 years
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- Remdesivir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 8 sitesThailand
- Study dates
- 16 Jul 2025to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
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- 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 cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Thailand8 sites, 8 recruiting
- Recruiting
Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University (CE-PID)
Bangkok, 10330
Napaporn Chantasrisawad, +662-2564930, napaporn.cha@chula.ac.th
Napaporn Chantasrisawad
- Recruiting
Nakornping Hospital
Chiang Mai, 50180
Suparat Kanjanavanit, +6653-999000 ext. Ext.0, skanjanavanit@gmail.com
Suparat Kanjanavanit
- Recruiting
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Tavitiya Sudjaritruk, +66053 936 150, tavitiya.s@cmu.ac.th
Tavitiya Sudjaritruk
- Recruiting
Chiangrai Prachanukroh Hospital
Chiang Rai, 5700
Suchada Ruenglerdpong, +6653 910 600, suchada.lan.rueng@gmail.com
Suchada Ruenglerdpong
- Not yet recruiting
Khon Kaen Hospital
Khon Kaen, 40000
Ussanee Srirompotong, +6643 009 900, u.srirompotong@gmail.com
Ussanee Srirompotong
- Recruiting
Lampang Hospital
Lampang, 52000
Mallika Rattanawijit, +6654 237 400, mrattana121@gmail.com
Mallika Rattanawijit
- Recruiting
Mahasarakham Hospital
Maha Sarakham, 44000
Supawan Papakhee, +6643 723 355, supawan.pa@chula.ac.th
Supawan Papakhee
- Not yet recruiting
Samut Sakhon Hospital
Samut Sakhon, 74000
Shalini Sachdev, +6634 429333, shalu.sachdev84@gmail.com
Shalini Sachdev
About this study
Official title: 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.
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.
Read the detailed description
An overall target of 120 participants will be involved in the study. Eligible participants will be randomized (1:1) to receive ARM 1: Standard of care alone (control arm). ARM 2: Remdesivir in combination with the standard of care. Remdesivir will be administered by intravenous infusion every 24 hours for five (5) consecutive days. Each participant will be followed during hospitalization plus 7-10 days after Day 6* for final visit.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- Remdesivir
- Keywords
- respiration disorders, RSV infection, Respiratory Syncytial Virus Hospitalizations
- Medical subject headings
- Respiration Disorders, Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemdesivirDrug
Also called VEKLURY®
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (control arm). | No intervention | Standard of care treatments will be delivered according to local practice at each hospital. The standard of care for lower respiratory tract infection includes oxygen therapy as needed, bronchodilators, intravenous fluids, in some cases the use of steroids, antibiotics and any treatment for underlying disease. |
| Intervention arm | Experimental | Remdesivir will be used in combination with the standard of care. Remdesivir will be administered by intravenous infusion every 24 hours for five (5) consecutive days with a dosage based on the participant's weight at the time of the randomisation. Receives: Drug: Remdesivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of Remdesivir
Outcome Measures:
Occurrence of the following events from the time of randomization until the last study visit:
- serious adverse events (SAEs);
- adverse events (AEs) of Grade 3 or higher
- treatment-related AEs
- AEs leading to treatment discontinuation
- treatment-related AEs leading to treatment discontinuation
- AEs of Grade 3 or higher leading to treatment discontinuation
Acceptability of daily remdesivir infusions to children, health care personnel, and caregivers assessed through questionnaires and direct observation.
Measured: 1 Week
Secondary outcomes (2)
Evaluation of the RSV RNA viral load
Outcome measures:
- Reduction in RSV RNA viral load reduction from Day 1 to Day 6, i.e. one day after the end of treatment.
- Time from Day 1 to RSV RNA viral load drop below the RT-PCR quantification limit until Day 6.
- Area under the RSV RNA viral load-time curve (AUC) from Day 1 until Day 6.
Measured: 1 Week
Efficacy of Remdesivir
Ourtome Measures:
Improvement on the PRESS 6-step ordinal scale from Day 1 until Day 6. PK parameters will be estimated for remdesivir and its metabolites GS-704277 and GS-44152417.
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start16 Jul 2025
- Primary completionJun 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PENTA Foundation
- Sponsor type
- Research network
- Collaborators
- AMS-PHPT Research Collaboration, Chiang Mai University, Hospital Universitario 12 de Octubre
- Responsible party
- Sponsor
- Investigators
- Tim R Cressey, Principal investigator, AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai UniversityTavitiya Sudjaritruk, Principal investigator, Department of Pediatrics, Faculty of Medicine, Chiang Mai UniversityPablo Rojo, Principal investigator, Hospital Materno Infantil 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873633
- Sponsor's protocol ID
- THAI-CARES RSV
- Other IDs
- CO-US-540-7443
- Acronym
- THAI-CARES RSV
- Status last verified
- Jul 2025
- First submitted
- 3 Mar 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06873633
- Acronym / sponsor ID
- THAI-CARES RSV / THAI-CARES RSV
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- respiration disorders, RSV infection, Respiratory Syncytial Virus Hospitalizations
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- PENTA FoundationResearch network
- Collaborators
- AMS-PHPT Research Collaboration, Chiang Mai University, Hospital Universitario 12 de Octubre
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An overall target of 120 participants will be involved in the study. Eligible participants will be randomized (1:1) to receive ARM 1: Standard of care alone (control arm). ARM 2: Remdesivir in combination with the standard of care. Remdesivir will be administered by intravenous infusion every 24 hours for five (5) consecutive days. Each participant will be followed during hospitalization plus 7-10 days after Day 6* for final visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care (control arm). | No intervention | –Standard of care treatments will be delivered according to local practice at each hospital. The standard of care for lower respiratory tract infection includes oxygen therapy as needed, bronchodilators, intravenous fluids, in some cases the use of steroids, antibiotics and any treatment for underlying disease. |
| Intervention arm | Experimental | Drug: RemdesivirRemdesivir will be used in combination with the standard of care. Remdesivir will be administered by intravenous infusion every 24 hours for five (5) consecutive days with a dosage based on the participant's weight at the time of the randomisation. |
Who may qualify
- Ages
- 0 days to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemdesivirAlso: VEKLURY®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. | Drug | Intervention arm |
Primary outcome
Safety and tolerability of Remdesivir
Time frame: 1 Week
Outcome Measures: Occurrence of the following events from the time of randomization until the last study visit: * serious adverse events (SAEs); * adverse events (AEs) of Grade 3 or higher * treatment-related AEs * AEs leading to treatment discontinuation * treatment-related AEs leading to treatment discontinuation * AEs of Grade 3 or higher leading to treatment discontinuation Acceptability of daily remdesivir infusions to children, health care personnel, and caregivers assessed through questionnaires and direct observation.
2 secondary outcomes
Evaluation of the RSV RNA viral load
Time frame: 1 Week
Efficacy of Remdesivir
Time frame: 1 Week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tim R Cressey principal investigator
AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University
Tavitiya Sudjaritruk principal investigator
Department of Pediatrics, Faculty of Medicine, Chiang Mai University
Pablo Rojo principal investigator
Hospital Materno Infantil 12 de Octubre
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remdesivir in people with Respiratory Syncytial Virus (RSV), run by PENTA Foundation at 8 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federica D'Ambrosio (+39 049 716 9848, federica.dambrosio@pentafoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of Remdesivir (time frame: 1 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.