Sisunatovir for RSV Infection
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: Pfizer
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Adults with RSV infection who are not hospitalized but at high risk for severe illness can join this study. Eligible participants include those over 18, especially if they're 65 or older, have chronic lung disease, heart failure, or weakened immune systems due to a condition or medication.Inclusion Criteria
I've recently had symptoms like a cold or flu.
I am 18 years old or older.
Treatment Details
The trial is testing Sisunatovir's safety and effectiveness against RSV in adults. Participants will randomly receive either Sisunatovir or a placebo (a look-alike with no medicine) orally for five days to compare outcomes.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SisunatovirExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a clinic near you
Research locations nearbySelect from list below to view details:
National Institute of Clinical Research - IrvineIrvine, CA
Accel Research Sites Network - St. Pete-Largo Clinical Research UnitLargo, FL
Ascension St. John HospitalGrosse Pointe Woods, MI
Next Level Urgent CareHouston, TX
More Trial Locations
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Who is running the clinical trial?
PfizerLead Sponsor