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Virus Therapy

Sisunatovir for RSV Infection

Phase 2 & 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Participants aged 18 years or older at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial studies sisunatovir to see if it is safe & effective for treating RSV in adults with high risk of severe illness. Participants attend 8-10 visits & receive either sisunatovir or placebo.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of Sisunatovir aren't detailed here but may include typical drug reactions like digestive issues, headaches, allergic responses, etc., which will be monitored through clinic visits and assessments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've recently had symptoms like a cold or flu.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SisunatovirExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sisunatovir
2023
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,670 Previous Clinical Trials
17,826,874 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,867,773 Total Patients Enrolled
~8 spots leftby Dec 2025
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