Sisunatovir for RSV Infection

Recruiting in Palo Alto (17 mi)

+198 other locations

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

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 am 65 or older, or have chronic lung disease, heart failure, or a condition that weakens my immune system.

I've recently had symptoms like a cold or flu.

You have been diagnosed with RSV infection within the past 5 days.

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Treatment Details

Interventions

Sisunatovir (Virus Therapy)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SisunatovirExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention