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Virus Therapy

Sisunatovir for Respiratory Syncytial Virus

Phase 2 & 3
Recruiting
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 10 days and 28 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 ~10 days and 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with Respiratory Syncytial Virus (RSV)-related hospitalization or death from any cause through Day 28, among patients treated ≤3 days after RSV symptom onset
Secondary outcome measures
Mean number of days alive and free from hospital stay (hospital-free days) through Day 28.
Proportion of participants with RSV-related hospitalization or death from any cause through Day 28.
Proportion of participants with Respiratory Syncytial Virus (RSV)-related visits or death from any cause through Day 28.
+2 more

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
~20

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,913,291 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,089,506 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation accept enrollees over the age of eighty-five?

"This study is inviting individuals above the age of majority and below their ninetieth birthday to take part in this medical trial."

Answered by AI

Is there still an opportunity to join this investigation?

"According to clinicaltrials.gov, this medical trial is no longer recruiting patients; the original posting date was December 5th 2023 and it has not been updated since then. Although there are presently 854 other trials that are enrolling participants."

Answered by AI

Are there any North American locations that are currently conducting this research?

"This clinical trial is active in 25 different locations, including Westminster, San Diego and Pittsburgh. Participants are encouraged to select the closest site when enrolling to minimize travel-related hardships."

Answered by AI

Is it possible for me to become a participant in this research endeavor?

"This clinical trial seeks 2715 individuals affected by respiratory syncytial virus, aged 18 or over. Eligibility requirements include age (18+ years old), evidence of RSV infection within 5 days prior to randomization, and at least one of the following comorbidities: chronic lung disease, heart failure, immunosuppressive diseases/medications; as well as new onset or deterioration in symptoms such as nasal congestion, discharge, sore throat etc."

Answered by AI

Who else is applying?

What site did they apply to?
National Institute of Clinical Research
Empire Clinical Research
Proactive Clinical Research,LLC
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection
2023. "A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06079320.
All > Paid Studies Las Vegas > Knoxville
~1810 spots leftby Aug 2025
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