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New RSV drug for babies shows promise in phase 3 trial

NCT ID NCT07402512

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 498 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

1 month to 36 months

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hunan Children's Hospital

    RECRUITING

    Changsha, Hunan, China

  • Shulan(hangzhou)Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital Of Xiamen University

    RECRUITING

    Xiamen, Fujian, China

  • West China Second University Hospital Sichuan University

    NOT_YET_RECRUITING

    Chengdu, Sichuan, China

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