A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection
NCT ID: NCT06079320
Last Updated: 2025-11-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
16 participants
INTERVENTIONAL
2023-12-08
2024-09-30
Brief Summary
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* who are not admitted to the hospital and
* who have high chances of having a severe illness from RSV infection.
This study is seeking participants who:
* Are confirmed to have RSV.
* Have symptoms of a lung infection.
* Are 18 years of age or older.
* Have one or more of the following which increases the chances of RSV illness:
* A long-term lung disease.
* heart failure.
* a condition that weakens the immune system.
* Are 65 years of age or older and do not have any of the conditions above
Half of the participants in this study will receive sisunatovir. The other half will receive a placebo for 5 days. Placebo looks same like the study medicine but does not have any medication. Both sisunatovir and placebo will be taken by mouth. The study will compare the experiences of people receiving sisunatovir to those of the people who do not. This will help decide if sisunatovir is safe and effective.
Participants will attend about 8-10 study visits over 5 weeks. During this time, they will have:
* visits at the study clinic,
* blood work,
* swabs of the nose,
* questionnaires,
* a follow-up phone call.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sisunatovir
Sisunatovir
Participants will receive tablets from Day 1 to Day 5
Placebo
Placebo
Participants will receive matching placebo tablets from Day 1 to Day 5
Interventions
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Sisunatovir
Participants will receive tablets from Day 1 to Day 5
Placebo
Participants will receive matching placebo tablets from Day 1 to Day 5
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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National Institute of Clinical Research
Garden Grove, California, United States
National Institute of Clinical Research
Westminster, California, United States
De La Cruz Research Center, LLC
Miami, Florida, United States
Adult Medicine of Lake County, Inc.
Mt. Dora, Florida, United States
Adult Medicine of Lake County
Mt. Dora, Florida, United States
Accellacare - DuPage
Oak Lawn, Illinois, United States
Mercury Street Medical Group, PLLC
Butte, Montana, United States
DM Clinical Research - AOM
Brooklyn, New York, United States
CHEAR Center LLC
The Bronx, New York, United States
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania, United States
Zenos Clinical Research
Dallas, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Salma Mazhar, MD PA
Mesquite, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
Shanghai Minhang District Central Hospital
Shanghai, , China
Maharaja Agrasen Superspeciality Hospital
Jaipur, Rajasthan, India
Koukankai Koukan Clinic
Kawasaki-Shi, Kanagawa, Japan
National Hospital Organization Minami Kyoto Hospital
Jōyō, Kyoto, Japan
Nanbu Tokushukai Hospital
Shimajiri, Okinawa, Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2023-505922-32-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C5241007
Identifier Type: -
Identifier Source: org_study_id