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New RSV drug tested in kids – but trial halted early

NCT ID NCT06102174

Disease control Sponsor: Pfizer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the safety and dosing of sisunatovir, an experimental antiviral drug, in infants and children up to 5 years old with RSV lower respiratory tract infection. Ten participants received either the drug or a placebo. The goal was to find the right dose for future studies. However, the trial was terminated early, so the full results may not be available.

What this could mean

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

Active substance
Sisunatovir (also known as PF-07923568, RV521)
What this could lead to
If successful, this study could help determine the right dose of sisunatovir for future trials in children with RSV, potentially leading to a treatment for severe RSV infections.
What could go wrong
This is a very early (phase 1b) and small study (only 10 participants) focused on safety and dosing, not on proving the drug works. The trial was terminated, so results may be limited.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Feb 2024

Finished

Sep 2024

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

1 day to 60 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 day to ≤60 months of age and weight ≥2.5 kg to ≤23 kg * Positive RSV diagnostic test, antigen or molecular test * Evidence of Lower Respiratory Tract Infection (LRTI) Exclusion Criteria: * Premature infants (gestational age less than 35 weeks) AND \<1 year of post-natal age * Neonates with intrauterine growth restriction * Expected to receive an antiviral for another viral infection within 10 days of screening * Suspected or confirmed clinically significant moderate or severe bacterial infection that may interfere with the evaluation of response to the study intervention * Known to have significant comorbidities that would limit the ability to administer the study intervention or evaluate the safety or clinical response to the study intervention

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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.

Respiratory syncytial virus infections

Contacts and locations

Locations

  • Kaiser Permanente

    Los Angeles, California, 90027, United States

  • Kaiser Permanente Los Angeles Medical center

    Los Angeles, California, 90027, United States

  • Kojunkai Daido Hospital

    Nagoya, Aichi-ken, 457-8511, Japan

  • Monti Clinical Research Centre

    Mdantsane, Eastern Cape, 5219, South Africa

  • Nintenkai Kagoshima Children's Hospital

    Hioki, Kagoshima-ken, 899-2503, Japan

  • Osaka City General Hospital

    Osaka, 534-0021, Japan

  • University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)

    Johannesburg, Gauteng, 2013, South Africa

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi, 400-8506, Japan

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