A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection
- Conditions
- Respiratory Syncytial Virus Infection
- Interventions
- Drug: Placebo
- Registration Number
- NCT06079320
- Lead Sponsor
- Pfizer
- 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 lung infections with cold-like symptoms, but it can cause severe illness in some people. Sisunatovir is studied in adults:
* 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Sisunatovir Sisunatovir -
- Primary Outcome Measures
Name Time Method Proportion of participants with Respiratory Syncytial Virus (RSV)-related hospitalization or death from any cause through Day 28 28 days
- Secondary Outcome Measures
Name Time Method Proportion of participants with progression or development of Lower Respiratory Tract Infection (LRTI) through Day 10 10 days Proportion of participants with Respiratory Syncytial Virus (RSV)-related visits or death from any cause through Day 28. 28 days Proportion of participants with resolution of LRTI at Day 15. 15 days Mean number of days alive and free from hospital stay (hospital-free days) through Day 28. 28 days
Trial Locations
- Locations (18)
National Institute of Clinical Research
๐บ๐ธWestminster, California, United States
Adult Medicine of Lake County, Inc.
๐บ๐ธMount Dora, Florida, United States
Adult Medicine of Lake County
๐บ๐ธMount Dora, Florida, United States
Mercury Street Medical Group, PLLC
๐บ๐ธButte, Montana, United States
De La Cruz Research Center, LLC
๐บ๐ธMiami, Florida, United States
Accellacare - DuPage
๐บ๐ธOak Lawn, Illinois, United States
CHEAR Center LLC
๐บ๐ธBronx, New York, United States
DM Clinical Research - AOM
๐บ๐ธBrooklyn, New York, United States
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
๐บ๐ธPittsburgh, Pennsylvania, United States
Zenos Clinical Research
๐บ๐ธDallas, Texas, United States
Biopharma Informatic, LLC
๐บ๐ธHouston, Texas, United States
Salma Mazhar, MD PA
๐บ๐ธMesquite, Texas, United States
SMS Clinical Research
๐บ๐ธMesquite, Texas, United States
Shanghai Minhang District Central Hospital
๐จ๐ณShanghai, China
Maharaja Agrasen Superspeciality Hospital
๐ฎ๐ณJaipur, Rajasthan, India
Koukankai Koukan Clinic
๐ฏ๐ตKawasaki-Shi, Kanagawa, Japan
National Hospital Organization Minami Kyoto Hospital
๐ฏ๐ตJoyo, Kyoto, Japan
Nanbu Tokushukai Hospital
๐ฏ๐ตShimajiri, Okinawa, Japan