RSV pill study halted early: what we know
NCT ID NCT06079320
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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16 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Sep 2024
- Lead sponsor
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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
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18 years and older
- 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: * 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
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Accellacare - DuPage
Oak Lawn, Illinois, 60453, United States
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Adult Medicine of Lake County
Mt. Dora, Florida, 32757, United States
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Adult Medicine of Lake County, Inc.
Mt. Dora, Florida, 32757, United States
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Biopharma Informatic, LLC
Houston, Texas, 77043, United States
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CHEAR Center LLC
The Bronx, New York, 10455, United States
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DM Clinical Research - AOM
Brooklyn, New York, 11220, United States
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De La Cruz Research Center, LLC
Miami, Florida, 33184, United States
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Koukankai Koukan Clinic
Kawasaki-Shi, Kanagawa, 210-0852, Japan
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Maharaja Agrasen Superspeciality Hospital
Jaipur, Rajasthan, 302039, India
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Mercury Street Medical Group, PLLC
Butte, Montana, 59701, United States
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Nanbu Tokushukai Hospital
Shimajiri, Okinawa, 901-0493, Japan
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National Hospital Organization Minami Kyoto Hospital
Jōyō, Kyoto, 610-0113, Japan
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National Institute of Clinical Research
Garden Grove, California, 92844, United States
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National Institute of Clinical Research
Westminster, California, 92683, United States
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Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania, 15236, United States
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SMS Clinical Research
Mesquite, Texas, 75149, United States
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Salma Mazhar, MD PA
Mesquite, Texas, 75149, United States
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Shanghai Minhang District Central Hospital
Shanghai, 201100, China
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Zenos Clinical Research
Dallas, Texas, 75230, United States
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Other studies related to the condition(s) this trial covers.
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