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RSV pill study halted early: what we know

NCT ID NCT06079320

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an oral drug called sisunatovir for treating RSV in adults who were not hospitalized but had a high risk of severe illness. Participants took either the drug or a placebo for 5 days. The study was terminated early, so results are 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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

16 people

The number who actually took part.

Started

Dec 2023

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

18 years and older

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: * Participants aged 18 years or older at screening. * Diagnosis of RSV infection collected within 5 days prior to randomization. * New onset or worsening (if present chronically) of at least one of the following signs and/or symptoms consistent with a viral acute respiratory infection (ARI), within 5 days prior to randomization: nasal congestion, nasal discharge, sore throat, cough, sputum production, shortness of breath, or wheezing. * Has at least 1 of the following characteristics or underlying medical conditions: a) 65 years of age or older b) Chronic lung disease, c) Heart failure, d) Immunosuppressive disease/condition or immune-weakening medications Exclusion Criteria: * Any medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study or interfere with the evaluation of response to the study intervention. * Diagnosis of viral respiratory infections other than RSV including influenza and SARS-CoV-2 * Current need for hospitalization or anticipated need for hospitalization for any reason to provide inpatient/acute care within 24 hours after randomization * Any clinically significant ECG abnormality in the pre-dose ECG that, per investigator judgement, may affect participant safety * Has hypersensitivity to or other contraindication to any of the components of the study interventions, as determined by the investigator.

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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.

Contacts and locations

Locations

  • Accellacare - DuPage

    Oak Lawn, Illinois, 60453, United States

  • Adult Medicine of Lake County

    Mt. Dora, Florida, 32757, United States

  • Adult Medicine of Lake County, Inc.

    Mt. Dora, Florida, 32757, United States

  • Biopharma Informatic, LLC

    Houston, Texas, 77043, United States

  • CHEAR Center LLC

    The Bronx, New York, 10455, United States

  • DM Clinical Research - AOM

    Brooklyn, New York, 11220, United States

  • De La Cruz Research Center, LLC

    Miami, Florida, 33184, United States

  • Koukankai Koukan Clinic

    Kawasaki-Shi, Kanagawa, 210-0852, Japan

  • Maharaja Agrasen Superspeciality Hospital

    Jaipur, Rajasthan, 302039, India

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701, United States

  • Nanbu Tokushukai Hospital

    Shimajiri, Okinawa, 901-0493, Japan

  • National Hospital Organization Minami Kyoto Hospital

    Jōyō, Kyoto, 610-0113, Japan

  • National Institute of Clinical Research

    Garden Grove, California, 92844, United States

  • National Institute of Clinical Research

    Westminster, California, 92683, United States

  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)

    Pittsburgh, Pennsylvania, 15236, United States

  • SMS Clinical Research

    Mesquite, Texas, 75149, United States

  • Salma Mazhar, MD PA

    Mesquite, Texas, 75149, United States

  • Shanghai Minhang District Central Hospital

    Shanghai, 201100, China

  • Zenos Clinical Research

    Dallas, Texas, 75230, United States

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