Status:
TERMINATED
A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection
Lead Sponsor:
Pfizer
Conditions:
Respiratory Syncytial Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to learn about the safety and effects of sisunatovir. Sisunatovir is studied for the possible treatment of Respiratory Syncytial Virus (RSV). RSV is a virus that causes lu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06079320
Start Date
December 8 2023
End Date
September 30 2024
Last Update
November 10 2025
Active Locations (19)
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1
National Institute of Clinical Research
Garden Grove, California, United States, 92844
2
National Institute of Clinical Research
Westminster, California, United States, 92683
3
De La Cruz Research Center, LLC
Miami, Florida, United States, 33184
4
Adult Medicine of Lake County, Inc.
Mt. Dora, Florida, United States, 32757