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Virus Therapy

Sisunatovir for RSV Infection

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of Lower Respiratory Tract Infection (LRTI)
1 day to ≤60 months of age and weight ≥2.5 kg to ≤23 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial is studying the safety and amount of sisunatovir in the blood of infants and children up to 5 years old who have a lower respiratory tract infection caused by respiratory syncytial

Who is the study for?
This trial is for infants and children up to 60 months old, weighing between 2.5 kg and 23 kg, who have pneumonia caused by RSV as confirmed by medical tests.
What is being tested?
The study is testing the safety of sisunatovir and how much of it gets into the blood in young patients with RSV-caused pneumonia. Participants will receive varying doses of sisunatovir or a placebo over up to seven visits.
What are the potential side effects?
While specific side effects are not listed here, they typically include reactions at the site where medicine is given, fever, changes in appetite or behavior, allergic reactions or other symptoms that will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have an infection in my lungs or airways below the voice box.
Select...
I am between 1 day and 60 months old and weigh between 2.5kg and 23kg.

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
Active Control
Placebo Group
Group I: SisunatovirActive Control1 Intervention
Oral or NG tube
Group II: PlaceboPlacebo Group1 Intervention
Oral or Nasogastric tube (NG)

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,171 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,758,027 Total Patients Enrolled
~5 spots leftby Dec 2025
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