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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06079320
Other study ID # C5241007
Secondary ID 2023-505922-32-0
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date December 8, 2023
Est. completion date August 30, 2025

Study information

Verified date May 2024
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2715
Est. completion date August 30, 2025
Est. primary completion date August 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Sisunatovir
Participants will receive tablets from Day 1 to Day 5
Placebo
Participants will receive matching placebo tablets from Day 1 to Day 5

Locations

Country Name City State
Canada Hamilton Medical Research Group Hamilton Ontario
China China-Japan Friendship Hospital Beijing Beijing
China Shanghai Minhang District Central Hospital Shanghai Shanghai
China Shanghai Minhang District Central Hospital Shanghai
Japan National Hospital Organization Asahikawa Medical Center Asahikawa Hokkaido
Japan National Hospital Organization Asahikawa Medical Center Asahikawa Hokkaido
Japan Fukuwa Clinic Chuo-ku Tokyo
Japan Chugoku Central Hospital Fukuyama Hiroshima
Japan National Hospital Organization Tenryu Hospital Hamamatsu Shizuoka
Japan National Hospital Organization Minami Kyoto Hospital Joyo Kyoto
Japan Shonankamakura General Hospital Kamakura Kanagawa
Japan National Hospital Organization Kanazawa Medical Center Kanazawa Ishikawa
Japan National Hospital Organization Osaka Minami Medical Center Kawachinagano Osaka
Japan Koukankai Koukan Clinic Kawasaki-Shi Kanagawa
Japan Shin Komonji Hospital Kitakyushu Fukuoka
Japan National Hospital Organization Tokyo National Hospital Kiyose Tokyo
Japan National Hospital Organization Kyoto Medical Center Kyoto-shi Kyoto
Japan Miyazaki Prefectural Miyazaki Hospital Miyazaki
Japan International University of Health and Welfare Narita Hospital Narita Chiba
Japan National Hospital Organization Okayama Medical Center Okayama
Japan Okayama City General Medical Center Okayama City Hospital Okayama
Japan Okayama University Hospital Okayama
Japan Teine Keijinkai Hospital Sapporo Hokkaido
Japan Nanbu Tokushukai Hospital Shimajiri Okinawa
Japan Saka General Hospital Shiogama Miyagi
Japan Tsuchiura Beryl Clinic Tsuchiura Ibaraki
Japan Nanbu Tokushukai Hospital Yaese Okinawa
Japan Nagata Hospital Yanagawa Fukuoka
United States Nayak Research, LLC Andrews Texas
United States Athens-Limestone Hospital Laboratory Athens Alabama
United States North Alabama Research Center Athens Alabama
United States ACRC - Main Austin Austin Texas
United States IMA Clinical Research Austin Austin Texas
United States National Institute of Clinical Research - Bakersfield Bakersfield California
United States Carbon Health - Brea - Brea Marketplace Brea California
United States CHEAR Center LLC Bronx New York
United States DM Clinical Research - Brooklyn Brooklyn New York
United States Mercury Street Medical Group, PLLC Butte Montana
United States Hope Clinical Research, Inc. Canoga Park California
United States ACRC TRIALS / Family Medicine Associates of Texas Carrollton Texas
United States Valley Medical Research Centerville Ohio
United States Javara - Tryon Medical Partners Charlotte North Carolina
United States OnSite Clinical Solutions Charlotte North Carolina
United States OnSite Clinical Solutions,LLC (Secondary Location) Charlotte North Carolina
United States WR-Clinsearch, LLC Chattanooga Tennessee
United States Velocity Clinical Research, Chula Vista Chula Vista California
United States Alpine Research Organization Clinton Utah
United States Invictus Clinical Research Group Coconut Creek Florida
United States Lynn Institute Of The Rockies Colorado Springs Colorado
United States Velocity Clinical Research, Columbia Columbia South Carolina
United States Javara - Privia Medical Group Gulf Coast - The Woodlands HWH Conroe Texas
United States Herco Medical and Research Center Inc Coral Gables Florida
United States Cullman Clinical Trials Cullman Alabama
United States Advance Clinical Research Group Cutler Bay Florida
United States North Texas Infectious Diseases Consultants, P.A Dallas Texas
United States WR-Global Medical Research, LLC Dallas Texas
United States Zenos Clinical Research Dallas Texas
United States I.V.A.M. Clinical & Investigational Center Doral Florida
United States Integrity Clinical Research Doral Florida
United States Accel Research Sites Network - Edgewater Clinical Research Unit Edgewater Florida
United States Primary Health Partners Edmond Oklahoma
United States Primary Health Partners Edmond Oklahoma
United States Tekton Research, LLC. Edmond Oklahoma
United States El Paso Pulmonary Association El Paso Texas
United States Michigan Center of Medical Research (MICHMER) Farmington Hills Michigan
United States Proactive Clinical Research,LLC Fort Lauderdale Florida
United States ACRC TRIALS / Catalyst Physician Group / Frisco Medical Village Frisco Texas
United States Velocity Clinical Research, Gaffney Gaffney South Carolina
United States National Institute of Clinical Research Garden Grove California
United States Velocity Clinical Research, Grand Island Grand Island Nebraska
United States Ascension St. John Hospital Grosse Pointe Woods Michigan
United States Velocity Clinical Research, Gulfport Gulfport Mississippi
United States NeoClinical Research Hialeah Florida
United States Qway Research LLC Hialeah Florida
United States Coastal Heritage Clinical Research Hinesville Georgia
United States Sunbright Health Medical Centers Homestead Florida
United States Biopharma Informatic, LLC Houston Texas
United States NeuroCare Partners, LLC Houston Texas
United States Next Level Urgent Care Houston Texas
United States Santa Clara Family Clinic Houston Texas
United States Synergy Groups Medical LLC - Broadway Houston Texas
United States Marvel Clinical Research Huntington Beach California
United States Community Medical Care Center Immokalee Florida
United States 310 Clinical Research Inglewood California
United States National Institute of Clinical Research - Irvine Irvine California
United States Wr-Msra.Llc Lake City Florida
United States Accel Research Sites Network - St. Pete-Largo Clinical Research Unit Largo Florida
United States Clinical Research of South Nevada Las Vegas Nevada
United States Excel Clinical Research, LLC Las Vegas Nevada
United States Las Vegas Clinical Trials Las Vegas Nevada
United States Wr-Crcn, Llc Las Vegas Nevada
United States Epic Clinical Research Lewisville Texas
United States Velocity Clinical Research, Lincoln Lincoln Nebraska
United States Applied Research Center of Arkansas Little Rock Arkansas
United States Long Beach Research Institute Long Beach California
United States Velocity Clinical Research, Medford Medford Oregon
United States SMS Clinical Research Mesquite Texas
United States Cruz Medical & Research Center Miami Florida
United States Premium Medical Research Corp Miami Florida
United States Global Health Research Center, Inc. Miami Lakes Florida
United States Synergy Groups Medical LLC - Missouri City Missouri City Texas
United States Velocity Clinical Research, Mobile Mobile Alabama
United States Clinical Trials of South Carolina Moncks Corner South Carolina
United States Adult Medicine of Lake County Mount Dora Florida
United States Adult Medicine of Lake County, Inc. Mount Dora Florida
United States Saltzer Health Nampa Idaho
United States Velocity Clinical Research, Norfolk Norfolk Nebraska
United States Carbon Health - North Hollywood - NoHo West North Hollywood California
United States Accellacare - DuPage Oak Lawn Illinois
United States Carbon Health - Oakland Oakland California
United States Carbon Health - New Jersey - Ocean Ocean Township New Jersey
United States Accel Research Sites Network - Ormond Clinical Research Unit Ormond Beach Florida
United States FOMAT Medical Research Oxnard California
United States Tapia Wellness and Research, LLC Paris Texas
United States Pasadena Clinical Trials - Pasadena - North Madison Avenue Pasadena California
United States Pasadena Clinical Trials - South Arroyo Parkway Pasadena California
United States Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) Pittsburgh Pennsylvania
United States Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair Pittsburgh Pennsylvania
United States ACRC Trials (Administrative Location) Plano Texas
United States ACRC Trials (Administrative Location) Plano Texas
United States Empire Clinical Research Pomona California
United States National Institute of Clinical Research - Pomona Pomona California
United States Velocity Clinical Research, Rockville Rockville Maryland
United States Accellacare - Rocky Mount Rocky Mount North Carolina
United States Accel Research Sites Network - Professional Urgent Care Services Saint Petersburg Florida
United States GCP Research, Global Clinical professionals Saint Petersburg Florida
United States Accellacare - Salisbury Salisbury North Carolina
United States DCT-Stone Oak, LLC dba Discovery Clinical Trials San Antonio Texas
United States Acclaim Clinical Research San Diego California
United States Javara - Privia Medical Group Georgia - Savannah Savannah Georgia
United States Javara - Privia Medical Group North Texas - Stephenville Stephenville Texas
United States Javara - Privia Medical Group Gulf Coast - Sugarland Sugar Land Texas
United States North Houston Internal Medicine & Pediatric Clinic Tomball Texas
United States Preferred Primary Care Physicians Uniontown Pennsylvania
United States Velocity Clinical Research, Vestal Vestal New York
United States National Institute of Clinical Research - Victorville - Hesperia Road Victorville California
United States National Institute of Clinical Research Westminster California
United States National Institute of Clinical Research, Inc. (Administrative Only) Westminster California
United States National Institute of Clinical Research, Inc. (Administrative Only) Westminster California
United States Accellacare - Wilmington Wilmington North Carolina
United States University of Massachusetts Chan Medical School Worcester Massachusetts
United States Tekton Research, LLC. Yukon Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  China,  Japan, 

Outcome

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