A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection

AN INTERVENTIONAL PHASE 2/3, ADAPTIVE, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ORAL SISUNATOVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULTS WITH RESPIRATORY SYNCYTIAL VIRUS INFECTION WHO ARE AT RISK OF PROGRESSION TO SEVERE ILLNESS

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Syncytial Virus Infection
• Intervention / Treatment: Drug: Sisunatovir; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 2715
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8M 1K7
      • Not yet recruiting
      • Hamilton Medical Research Group
• China
  • Shanghai, China, 201100
    • Recruiting
    • Shanghai Minhang District Central Hospital
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 201100
      • Recruiting
      • Shanghai Minhang District Central Hospital
• Japan
  • Miyazaki, Japan, 880-8510
    • Not yet recruiting
    • Miyazaki Prefectural Miyazaki Hospital
  • Okayama, Japan, 700-8558
    • Not yet recruiting
    • Okayama University Hospital
  • Okayama, Japan, 700-8557
    • Not yet recruiting
    • Okayama City General Medical Center Okayama City Hospital
  • Okayama, Japan, 701-1192
    • Not yet recruiting
    • National Hospital Organization Okayama Medical Center
  • Chiba
    • Narita, Chiba, Japan, 286-8520
      • Not yet recruiting
      • International University of Health and Welfare Narita Hospital
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 800-0057
      • Not yet recruiting
      • Shin Komonji Hospital
    • Yanagawa, Fukuoka, Japan, 832-0059
      • Not yet recruiting
      • Nagata Hospital
  • Hiroshima
    • Fukuyama, Hiroshima, Japan, 720-0001
      • Not yet recruiting
      • Chugoku Central Hospital
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-8644
      • Not yet recruiting
      • National Hospital Organization Asahikawa Medical Center
    • Asahikawa, Hokkaido, Japan, 0700901
      • Not yet recruiting
      • National Hospital Organization Asahikawa Medical Center
    • Sapporo, Hokkaido, Japan, 006-8555
      • Not yet recruiting
      • Teine Keijinkai Hospital
  • Ibaraki
    • Tsuchiura, Ibaraki, Japan, 300-0062
      • Not yet recruiting
      • Tsuchiura Beryl Clinic
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8650
      • Not yet recruiting
      • National Hospital Organization Kanazawa Medical Center
  • Kanagawa
    • Kamakura, Kanagawa, Japan, 247-8533
      • Not yet recruiting
      • Shonankamakura General Hospital
    • Kawasaki-Shi, Kanagawa, Japan, 210-0852
      • Not yet recruiting
      • Koukankai Koukan Clinic
  • Kyoto
    • Joyo, Kyoto, Japan, 610-0113
      • Not yet recruiting
      • National Hospital Organization Minami Kyoto Hospital
    • Kyoto-shi, Kyoto, Japan, 612-8555
      • Recruiting
      • National Hospital Organization Kyoto Medical Center
  • Miyagi
    • Shiogama, Miyagi, Japan, 985-8506
      • Not yet recruiting
      • Saka General Hospital
  • Okinawa
    • Shimajiri, Okinawa, Japan, 901-0493
      • Recruiting
      • Nanbu Tokushukai Hospital
    • Yaese, Okinawa, Japan, 901-0417
      • Recruiting
      • Nanbu Tokushukai Hospital
  • Osaka
    • Kawachinagano, Osaka, Japan, 586-8521
      • Not yet recruiting
      • National Hospital Organization Osaka Minami Medical Center
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 434-8511
      • Not yet recruiting
      • National Hospital Organization Tenryu Hospital
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Not yet recruiting
      • Fukuwa Clinic
    • Kiyose, Tokyo, Japan, 204-8585
      • Not yet recruiting
      • National Hospital Organization Tokyo National Hospital
• United States
  • Alabama
    • Athens, Alabama, United States, 35611
      • Not yet recruiting
      • North Alabama Research Center
    • Athens, Alabama, United States, 35611
      • Not yet recruiting
      • Athens-Limestone Hospital Laboratory
    • Cullman, Alabama, United States, 35055
      • Not yet recruiting
      • Cullman Clinical Trials
    • Mobile, Alabama, United States, 36608
      • Not yet recruiting
      • Velocity Clinical Research, Mobile
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Recruiting
      • Applied Research Center of Arkansas
  • California
    • Bakersfield, California, United States, 93309
      • Not yet recruiting
      • National Institute of Clinical Research - Bakersfield
    • Brea, California, United States, 92821
      • Not yet recruiting
      • Carbon Health - Brea - Brea Marketplace
    • Canoga Park, California, United States, 91303
      • Not yet recruiting
      • Hope Clinical Research, Inc.
    • Chula Vista, California, United States, 91911
      • Not yet recruiting
      • Velocity Clinical Research, Chula Vista
    • Garden Grove, California, United States, 92844
      • Recruiting
      • National Institute of Clinical Research
    • Huntington Beach, California, United States, 92647
      • Not yet recruiting
      • Marvel Clinical Research
    • Inglewood, California, United States, 90301
      • Recruiting
      • 310 Clinical Research
    • Irvine, California, United States, 92614
      • Recruiting
      • National Institute of Clinical Research - Irvine
    • Long Beach, California, United States, 90805
      • Not yet recruiting
      • Long Beach Research Institute
    • North Hollywood, California, United States, 91606
      • Recruiting
      • Carbon Health - North Hollywood - NoHo West
    • Oakland, California, United States, 94610
      • Recruiting
      • Carbon Health - Oakland
    • Oxnard, California, United States, 93030
      • Not yet recruiting
      • FOMAT Medical Research
    • Pasadena, California, United States, 91105
      • Not yet recruiting
      • Pasadena Clinical Trials - South Arroyo Parkway
    • Pasadena, California, United States, 91101
      • Not yet recruiting
      • Pasadena Clinical Trials - Pasadena - North Madison Avenue
    • Pomona, California, United States, 91767
      • Recruiting
      • Empire Clinical Research
    • Pomona, California, United States, 91768
      • Not yet recruiting
      • National Institute of Clinical Research - Pomona
    • San Diego, California, United States, 92120
      • Not yet recruiting
      • Acclaim Clinical Research
    • Victorville, California, United States, 92395
      • Not yet recruiting
      • National Institute of Clinical Research - Victorville - Hesperia Road
    • Westminster, California, United States, 92683
      • Not yet recruiting
      • National Institute of Clinical Research, Inc. (Administrative Only)
    • Westminster, California, United States, 92683
      • Recruiting
      • National Institute of Clinical Research
    • Westminster, California, United States, 92683
      • Recruiting
      • National Institute of Clinical Research, Inc. (Administrative Only)
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Not yet recruiting
      • Lynn Institute Of The Rockies
  • Florida
    • Coconut Creek, Florida, United States, 33073
      • Recruiting
      • Invictus Clinical Research Group
    • Coral Gables, Florida, United States, 33134
      • Not yet recruiting
      • Herco Medical and Research Center Inc
    • Cutler Bay, Florida, United States, 33157
      • Recruiting
      • Advance Clinical Research Group
    • Doral, Florida, United States, 33122
      • Not yet recruiting
      • Integrity Clinical Research
    • Doral, Florida, United States, 33126
      • Not yet recruiting
      • I.V.A.M. Clinical & Investigational Center
    • Edgewater, Florida, United States, 32132
      • Recruiting
      • Accel Research Sites Network - Edgewater Clinical Research Unit
    • Fort Lauderdale, Florida, United States, 33308
      • Recruiting
      • Proactive Clinical Research,LLC
    • Hialeah, Florida, United States, 33010
      • Not yet recruiting
      • Qway Research LLC
    • Hialeah, Florida, United States, 33016
      • Not yet recruiting
      • NeoClinical Research
    • Homestead, Florida, United States, 33032
      • Not yet recruiting
      • Sunbright Health Medical Centers
    • Immokalee, Florida, United States, 34142
      • Not yet recruiting
      • Community Medical Care Center
    • Lake City, Florida, United States, 32055
      • Recruiting
      • Wr-Msra.Llc
    • Largo, Florida, United States, 33777
      • Not yet recruiting
      • Accel Research Sites Network - St. Pete-Largo Clinical Research Unit
    • Miami, Florida, United States, 33126
      • Not yet recruiting
      • Premium Medical Research Corp
    • Miami, Florida, United States, 33184
      • Recruiting
      • Cruz Medical & Research Center
    • Miami Lakes, Florida, United States, 33016
      • Not yet recruiting
      • Global Health Research Center, Inc.
    • Mount Dora, Florida, United States, 32757
      • Recruiting
      • Adult Medicine of Lake County
    • Mount Dora, Florida, United States, 32757
      • Recruiting
      • Adult Medicine of Lake County, Inc.
    • Ormond Beach, Florida, United States, 32174
      • Recruiting
      • Accel Research Sites Network - Ormond Clinical Research Unit
    • Saint Petersburg, Florida, United States, 33705
      • Not yet recruiting
      • GCP Research, Global Clinical professionals
    • Saint Petersburg, Florida, United States, 33710
      • Not yet recruiting
      • Accel Research Sites Network - Professional Urgent Care Services
  • Georgia
    • Hinesville, Georgia, United States, 31313
      • Not yet recruiting
      • Coastal Heritage Clinical Research
    • Savannah, Georgia, United States, 31406
      • Not yet recruiting
      • Javara - Privia Medical Group Georgia - Savannah
  • Idaho
    • Nampa, Idaho, United States, 83686
      • Not yet recruiting
      • Saltzer Health
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Recruiting
      • Accellacare - DuPage
  • Maryland
    • Rockville, Maryland, United States, 20854
      • Not yet recruiting
      • Velocity Clinical Research, Rockville
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Not yet recruiting
      • University of Massachusetts Chan Medical School
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Not yet recruiting
      • Michigan Center of Medical Research (MICHMER)
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Recruiting
      • Ascension St. John Hospital
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Recruiting
      • Velocity Clinical Research, Gulfport
  • Montana
    • Butte, Montana, United States, 59701
      • Recruiting
      • Mercury Street Medical Group, PLLC
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Recruiting
      • Velocity Clinical Research, Grand Island
    • Lincoln, Nebraska, United States, 68510
      • Recruiting
      • Velocity Clinical Research, Lincoln
    • Norfolk, Nebraska, United States, 68701
      • Recruiting
      • Velocity Clinical Research, Norfolk
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Not yet recruiting
      • Excel Clinical Research, LLC
    • Las Vegas, Nevada, United States, 89030
      • Not yet recruiting
      • Las Vegas Clinical Trials
    • Las Vegas, Nevada, United States, 89106
      • Not yet recruiting
      • Wr-Crcn, Llc
    • Las Vegas, Nevada, United States, 89121-4350
      • Not yet recruiting
      • Clinical Research of South Nevada
  • New Jersey
    • Ocean Township, New Jersey, United States, 07712
      • Not yet recruiting
      • Carbon Health - New Jersey - Ocean
  • New York
    • Bronx, New York, United States, 10455
      • Recruiting
      • Chear Center LLC
    • Brooklyn, New York, United States, 11220
      • Recruiting
      • DM Clinical Research - Brooklyn
    • Vestal, New York, United States, 13850
      • Not yet recruiting
      • Velocity Clinical Research, Vestal
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Not yet recruiting
      • Onsite Clinical Solutions
    • Charlotte, North Carolina, United States, 28210
      • Not yet recruiting
      • Javara - Tryon Medical Partners
    • Charlotte, North Carolina, United States, 28277
      • Not yet recruiting
      • OnSite Clinical Solutions,LLC (Secondary Location)
    • Rocky Mount, North Carolina, United States, 27804
      • Not yet recruiting
      • Accellacare - Rocky Mount
    • Salisbury, North Carolina, United States, 28144
      • Not yet recruiting
      • Accellacare - Salisbury
    • Wilmington, North Carolina, United States, 28401
      • Not yet recruiting
      • Accellacare - Wilmington
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Not yet recruiting
      • Valley Medical Research
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Recruiting
      • Primary Health Partners
    • Edmond, Oklahoma, United States, 73013
      • Recruiting
      • Tekton Research, LLC.
    • Edmond, Oklahoma, United States, 73034
      • Recruiting
      • Primary Health Partners
    • Yukon, Oklahoma, United States, 73099
      • Recruiting
      • Tekton Research, LLC.
  • Oregon
    • Medford, Oregon, United States, 97504
      • Not yet recruiting
      • Velocity Clinical Research, Medford
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15236
      • Not yet recruiting
      • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
    • Pittsburgh, Pennsylvania, United States, 15243
      • Not yet recruiting
      • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
    • Uniontown, Pennsylvania, United States, 15401
      • Not yet recruiting
      • Preferred Primary Care Physicians
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Not yet recruiting
      • Velocity Clinical Research, Columbia
    • Gaffney, South Carolina, United States, 29340
      • Not yet recruiting
      • Velocity Clinical Research, Gaffney
    • Moncks Corner, South Carolina, United States, 29461
      • Not yet recruiting
      • Clinical Trials of South Carolina
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Recruiting
      • WR-ClinSearch, LLC
  • Texas
    • Andrews, Texas, United States, 79714
      • Not yet recruiting
      • Nayak Research, LLC
    • Austin, Texas, United States, 78745
      • Not yet recruiting
      • IMA Clinical Research Austin
    • Austin, Texas, United States, 78735
      • Not yet recruiting
      • ACRC - Main Austin
    • Carrollton, Texas, United States, 75010
      • Not yet recruiting
      • ACRC TRIALS / Family Medicine Associates of Texas
    • Conroe, Texas, United States, 77384
      • Recruiting
      • Javara - Privia Medical Group Gulf Coast - The Woodlands HWH
    • Dallas, Texas, United States, 75246
      • Recruiting
      • North Texas Infectious Diseases Consultants, P.A
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Zenos Clinical Research
    • Dallas, Texas, United States, 75224
      • Not yet recruiting
      • WR-Global Medical Research, LLC
    • El Paso, Texas, United States, 79902
      • Not yet recruiting
      • El Paso Pulmonary Association
    • Frisco, Texas, United States, 75033
      • Recruiting
      • ACRC TRIALS / Catalyst Physician Group / Frisco Medical Village
    • Houston, Texas, United States, 77043
      • Recruiting
      • Biopharma Informatic, LLC
    • Houston, Texas, United States, 77057
      • Recruiting
      • Next Level Urgent Care
    • Houston, Texas, United States, 77087
      • Not yet recruiting
      • Santa Clara Family Clinic
    • Houston, Texas, United States, 77008
      • Not yet recruiting
      • NeuroCare Partners, LLC
    • Houston, Texas, United States, 77061
      • Not yet recruiting
      • Synergy Groups Medical LLC - Broadway
    • Lewisville, Texas, United States, 75057
      • Not yet recruiting
      • Epic Clinical Research
    • Mesquite, Texas, United States, 75149
      • Recruiting
      • SMS Clinical Research
    • Missouri City, Texas, United States, 77459
      • Not yet recruiting
      • Synergy Groups Medical LLC - Missouri City
    • Paris, Texas, United States, 75462
      • Not yet recruiting
      • Tapia Wellness and Research, LLC
    • Plano, Texas, United States, 75024
      • Not yet recruiting
      • ACRC Trials (Administrative Location)
    • Plano, Texas, United States, 75024
      • Recruiting
      • ACRC Trials (Administrative Location)
    • San Antonio, Texas, United States, 78258
      • Not yet recruiting
      • DCT-Stone Oak, LLC dba Discovery Clinical Trials
    • Stephenville, Texas, United States, 76401
      • Not yet recruiting
      • Javara - Privia Medical Group North Texas - Stephenville
    • Sugar Land, Texas, United States, 77478
      • Not yet recruiting
      • Javara - Privia Medical Group Gulf Coast - Sugarland
    • Tomball, Texas, United States, 77375
      • Not yet recruiting
      • North Houston Internal Medicine & Pediatric Clinic
  • Utah
    • Clinton, Utah, United States, 84015
      • Not yet recruiting
      • Alpine Research Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants aged 18 years or older at screening.
• Diagnosis of RSV infection collected within 5 days prior to randomization.
• 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.
• Has at least 1 of the following characteristics or underlying medical conditions: a) 65 years of age or older b) Chronic lung disease, c) Heart failure, d) Immunosuppressive disease/condition or immune-weakening medications

Exclusion Criteria:

• Any medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study or interfere with the evaluation of response to the study intervention.
• Diagnosis of viral respiratory infections other than RSV including influenza and SARS-CoV-2
• Current need for hospitalization or anticipated need for hospitalization for any reason to provide inpatient/acute care within 24 hours after randomization
• Known history or has risk factors for QT prolongation or Torsades de Pointes or congenital deafness, family history of long QT syndrome or unexplained sudden death, or a standard 12-lead ECG with QTcF ≥450 ms
• Has hypersensitivity to or other contraindication to any of the components of the study interventions, as determined by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Participants will receive matching placebo tablets from Day 1 to Day 5
Experimental: Sisunatovir	Drug: Sisunatovir; Participants will receive tablets from Day 1 to Day 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with RSV-related hospitalization or death from any cause through Day 28.	10 days and 28 days
Proportion of participants with Respiratory Syncytial Virus (RSV)-related visits or death from any cause through Day 28.	28 days
Proportion of participants with progression or development of Lower Respiratory Tract Infection (LRTI) through Day 10	10 days
Proportion of participants with resolution of LRTI at Day 15.	15 days
Mean number of days alive and free from hospital stay (hospital-free days) through Day 28.	28 days

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2023
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Disease Attributes; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: C5241007; 2023-505922-32-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes