New RSV drug for babies shows promise in phase 3 trial
NCT ID NCT07402512
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 3 trial tests an oral medicine called deurremidevir in infants and young children (1 month to 3 years old) with RSV infection. The goal is to see if it can shorten the time until symptoms like wheezing and rapid breathing go away. About 498 children will receive either the drug or a placebo for 5 days. If successful, it could offer a new way to help babies recover faster from RSV.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- deurremidevir hydrobromide (oral suspension)
- What this could lead to
- If it works, this could provide a fast-acting treatment to ease RSV symptoms in infants and young children, reducing hospital stays and breathing distress.
- What could go wrong
- This is still a placebo-controlled trial, so the drug may not prove better than placebo. Side effects in very young children are unknown, and results may not apply to all RSV cases.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 498 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 month to 36 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Infants and young children aged ≥ 1 month and ≤ 36 months, regardless of gender; 2. Weight ≥ 2.5 kg and ≤ 20 kg; 3. Positive RSV antigen or nucleic acid test 4. Duration of illness due to RSV infection ≤ 96 hours; 5. Presence of tachypnea and wheezing; 6. Wang Bronchiolitis Score≥ 5; 7. For subjects aged \< 12 months, head circumference should be within the normal range corresponding to their age and gender. Exclusion Criteria: 1. Subjects who have received protocol-specified prohibited medications: 2. Subjects with severe intrapulmonary complications or extrapulmonary complications; 3. Subjects requiring vasopressors or inotropic agents; 4. Subjects with known concurrent SARS-CoV-2 infection, influenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections; 5. Subjects with a known history of hypercapnia; 6. Subjects with chronic or persistent feeding difficulties; 7. Subjects with gastrointestinal diseases that the investigator believes may significantly affect the absorption of the study drug; 8. Subjects with congenital metabolic abnormalities; 9. Subjects with bronchopulmonary dysplasia requiring assisted ventilation or clinically significant congenital respiratory tract abnormalities; 10. Subjects with congenital heart disease (CHD) that the investigator assesses may affect efficacy evaluation; 11. Subjects with clinical evidence of hepatic decompensation; or abnormal liver function tests; 12. Subjects with renal failure, including renal abnormalities potentially related to renal insufficiency or abnormal renal function tests; 13. Subjects with a known history of HIV positivity, or suspected to be HIV positive by the investigator; 14. Subjects with known or suspected primary immunodeficiency diseases or transplant recipients; 15. Subjects with a history of epilepsy or febrile convulsions; 16. Subjects with a personal or family history of severe allergies or allergies; 17. Subjects with active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal diseases, or other medical conditions deemed unsuitable for enrollment by the investigator; 18. Subjects who participated in other drug or medical device clinical trials and received investigational products or devices; 19. Subjects deemed unsuitable for participation in this study by the investigator for any other reason.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hunan Children's Hospital
RECRUITINGChangsha, Hunan, China
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Shulan(hangzhou)Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, China
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The First Affiliated Hospital Of Xiamen University
RECRUITINGXiamen, Fujian, China
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West China Second University Hospital Sichuan University
NOT_YET_RECRUITINGChengdu, Sichuan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple breath test catch flu in High-HIV regions?
- RSV drug trial for kids under 5 halted early – only 4 children enrolled
- Could a shot for moms shield babies from deadly RSV?
- RSV study seeks immune clues in older adults
- New study aims to predict severe bronchiolitis in infants
- New RSV vaccine shows promise for seniors in large trial