Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

RSV drug trial for kids under 5 halted early – only 4 children enrolled

NCT ID NCT06784973

Symptom relief Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an oral antiviral drug called obeldesivir in children from birth to under 5 years old who had RSV infection. The goal was to see if the drug is safe and helps reduce symptoms faster. However, the trial was stopped early and only enrolled 4 participants, so the results are very limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
obeldesivir (an antiviral drug taken by mouth)
What this could lead to
If it works, this could provide a treatment to help young children recover faster from RSV infection.
What could go wrong
The trial was terminated early with only 4 participants, so there is very little data to know if it is safe or effective. It may not work or could have side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

4 people

The number who actually took part.

Started

Mar 2025

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 5 years

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.

Key Inclusion Criteria: * Participants assigned male or female at birth, from birth to \< 5 years of age who meet one of the following criteria, where permitted according to local law and approved nationally and by relevant institutional review board or independent ethics committee: * Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 3 kg to \< 40 kg (Part A) and ≥ 1.5 kg to \< 3 kg (Part B) * Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to \< 6 kg * RSV infection diagnosis ≤ 3 days prior to randomization. * Negative test for influenza A/B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 infection) ≤ 7 days prior to randomization. * Onset of RSV signs or symptoms ≤ 3 days prior to randomization. * Presence of at least 1 sign or symptom of RSV infection at screening and at randomization. Key Exclusion Criteria: * Currently requiring or expected to require hospitalization for RSV infection within 48 hours after randomization. * Not expected to survive the current RSV-related illness. * Documented previous infection and/or hospitalization for RSV during the current respiratory virus season. * Diagnosed with acute concurrent active systemic infections requiring treatment with systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy, or with any documented respiratory viral infection (other than RSV), ≤ 7 days prior to randomization. * History of asthma or recurrent wheezing. * Neuromuscular disease that affects swallowing. * Cystic fibrosis. * Participants who are immunocompromised. * Alanine aminotransferase ≥ 5 × upper limit of normal (ULN). * Abnormal renal function. * Concurrent or previous treatment with other agents with actual or possible direct antiviral activity against RSV, received within 28 days or within 5 half-lives, whichever is longer, prior to randomization. * Received palivizumab within 100 days, or nirsevimab within 1 year, or other RSV specific monoclonal antibody within 5 half-lives of the antibody, prior to randomization. * Participant whose mother received RSV vaccination during pregnancy and who is \< 1 year old prior to randomization. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Respiratory syncytial virus infection are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

RSV infection

Contacts and locations

Locations

  • Abe Child Clinic

    Kanagawa, 223-0051, Japan

  • Alliance Research Institute

    Lynwood, California, 90262, United States

  • Biopharma Informatic, LLC

    Houston, Texas, 77043, United States

  • Biopharma Informatic, LLC

    Houston, Texas, 77084, United States

  • Boeson Research

    Great Falls, Montana, 59405, United States

  • Boeson Research

    Kalispell, Montana, 59901, United States

  • Boeson Research

    Missoula, Montana, 59804, United States

  • Boeson Research PVU

    Provo, Utah, 84604, United States

  • Central Texas Medical Research, LLC

    San Antonio, Texas, 78232, United States

  • Child Health Care Associates

    Syracuse, New York, 13210, United States

  • Children's of Alabama

    Birmingham, Alabama, 35233, United States

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404, United States

  • Cohen Children's Medical Center Pharmacy New Pavillion

    Phoenix, Arizona, 11040, United States

  • Dolphin Medical Research

    Doral, Florida, 33172, United States

  • Epic Medical Research - DeSoto

    DeSoto, Texas, 75115, United States

  • Epic Medical Research -Oklahoma

    Chickasha, Oklahoma, 73018, United States

  • FOMAT - Jeffrey Kaplan MD Inc Pediatric Medicine

    Santa Maria, California, 93454, United States

  • Helios Clinical Research

    Burleson, Texas, 76028, United States

  • Helios Clinical Research

    Houston, Texas, 77008, United States

  • Isesaki Municipal Hospital

    Isesaki, 372-0817, Japan

  • Japan Community Healthcare Organization Chukyo Hospital

    Nagoya, Japan

  • Japan Community Healthcare Organization Kyushu Hospital

    Fkitakyushu, 806-0034, Japan

  • Kochi Health Sciences Center

    Kochi, 781-8555, Japan

  • Midway Medical Clinic

    Oneonta, Alabama, 35121, United States

  • Nona Pediatric Center

    Orlando, Florida, 32829, United States

  • North Houston Internal Medicine and Pediatric Clinic

    Tomball, Texas, 77375, United States

  • Okada Kodomonomori Clinic

    Kasukabe, 344-0011, Japan

  • PAS Research

    Tampa, Florida, 33613, United States

  • PAS Research

    Pittsburgh, Pennsylvania, 15227, United States

  • PAS Research

    Edinburg, Texas, 78539, United States

  • Paradigm Clinical Research

    Modesto, California, 95355, United States

  • Paradigm Clinical Research Centers, LLC

    San Diego, California, 92108, United States

  • Pediatric Center

    Richmond, Texas, 77469, United States

  • Pioneer Research Solutions Inc.

    Houston, Texas, 77099, United States

  • Radiance Clinical Research

    Lampasas, Texas, 76550, United States

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291, United States

  • Ryuseidai Children's Clinic

    Ibaraki, 305-0008, Japan

  • SEKI Children's CLINIC

    Fukuoka, 814-0123, Japan

  • Shimamura Memorial Hospital

    Nerima-ku, 177-0051, Japan

  • Shindo Children's Clinic

    Fukuoka, 814-0121, Japan

  • Shizuoka City Shimizu Hospital

    Shizuoka, 424-8636, Japan

  • Shizuoka Welfare Hospital

    Shizuoka, 420-0005, Japan

  • Sunrise Pediatrics

    Houston, Texas, 77077, United States

  • Tanner Clinic

    Kaysville, Utah, 84037, United States

  • Tanner Clinic

    Layton, Utah, 84041, United States

  • Tekton Research, LLC

    Yukon, Oklahoma, 73099, United States

  • UCLA (Outpatient Clinic)

    Los Angeles, California, 90095, United States

  • Uchida child clinic

    Fukuoka, 814-0104, Japan

  • Velocity Clinical Research - Norfolk

    Norfolk, Nebraska, 68701, United States

  • Velocity Clinical Research, Lafayette

    Lafayette, Louisiana, 70508, United States

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska, 68134, United States

  • Velocity Clinical Research, Phoenix

    Phoenix, Arizona, 85015, United States

  • Velocity Clinical Research, Sioux City

    Sioux City, Iowa, 51106, United States

  • Velocity Clinical Research, Washington DC

    Washington D.C., District of Columbia, 20016, United States

  • Yoshimura Child Clinic

    Akashi, 674-0068, Japan

  • Yutaka Children Clinic

    Kobe, 651-2273, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.