Respiratory Syncytial Virus Infection Clinical Trial
Official title:
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.
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Canada, China, Japan,
| 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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