A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus Who Are at High Risk of Progression to Severe Disease
Status: Recruiting
Location: See all (64) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main purpose of this study is to investigate the antiviral effect of S-337395 compared with placebo among nonhospitalized adult participants with high-risk factors for progression to severe RSV infection starting intervention within 72 hours of RSV symptom onset.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants who have new onset or worsening (if present chronically) of at least 1 of the following signs and/or symptoms consistent with a viral acute respiratory infection within 72 hours prior to randomization: fever, nasal congestion, nasal discharge, sore throat, cough, sputum production, shortness of breath, or wheezing.
• Participants diagnosed with RSV infection preferably using a rapid polymerase chain reaction (PCR) or other molecular-based diagnostic assay.
• Has at least 1 of the following risk factors for severe RSV disease:
‣ ≥ 75 years of age;
⁃ Chronic lung disease that is symptomatic and requiring chronic treatment; and
⁃ Chronic cardiovascular disease that is symptomatic and requiring chronic treatment.
• With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening.
Locations
United States
California
LA Universal Research Center, Inc.
RECRUITING
Los Angeles
Med Partnes, Inc - Elligo- PPDS
RECRUITING
Toluca Lake
Florida
Hope Clinical Trials - 3970 W Flagler St.
RECRUITING
Coral Gables
Beautiful Minds Clinical Research Center
RECRUITING
Cutler Bay
Doral Medical Research
RECRUITING
Hialeah
Continental Clinical Research, LLC
RECRUITING
Miami
Dynamic Medical Research, LLC - Miami
RECRUITING
Miami
LCC Medical Research - Miami - BTC - PPDS
RECRUITING
Miami
Miami Clinical Research, LLP.
RECRUITING
Miami
Nuren Medical and Research Center
RECRUITING
Miami
Reed Medical Research
RECRUITING
Miami
Southern Clinical Research
RECRUITING
Miami
Palm Springs Community Health Center
RECRUITING
Miami Lakes
Oceanic Research Group, LLC
RECRUITING
North Miami Beach
CDC Research Institute, LLC
RECRUITING
Port Saint Lucie
Cordova Research Insittute
RECRUITING
Sweetwater
Angels Clinical Research Institute Tampa-Palm Springs
RECRUITING
Tampa
Better Life Clinical Research LLC
RECRUITING
Tampa
Research Bay,Inc.
RECRUITING
Tampa
Santos Research Center - 5927 Webb Rd
RECRUITING
Tampa
Georgia
Covenant Pulmonary Criticial Care and Research Ins
RECRUITING
East Point
Missouri
Clay Platte Family Medicine - CCT Research
RECRUITING
Kansas City
North Carolina
Progressive Medicine of the Triad, LLC
RECRUITING
Winston-salem
New York
Prime Global Research, Inc.
RECRUITING
The Bronx
Oklahoma
Epic Medical Research - Chickasha
RECRUITING
Chickasha
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Texas
Epic Med. Research LLC, DeSoto
RECRUITING
Desoto
SMS Clinical Research, LLC - 400 W. Kearney St
RECRUITING
Mesquite
Virginia
Clinical Research Partners LLC
RECRUITING
Richmond
West Virginia
Frontier Clinical Research Waterfront
RECRUITING
Morgantown
Other Locations
Bulgaria
MCpulmo-2018 Ltd
RECRUITING
Haskovo
Medical Center Hera EOOD, Montana
RECRUITING
Montana
Medical Center Hera EOOD
RECRUITING
Sofia
Japan
Yamaichi Building Internal Medicine Clinic
RECRUITING
Adachi-ku
Doi Clinic
RECRUITING
Chikushino-shi
Ebino Centro Clinic
RECRUITING
Ebino
Irie Clinic
RECRUITING
Fukuoka
Tomita Internal Medicine Clinic
RECRUITING
Fukuoka-shi Chuo-ku
PS Clinic
RECRUITING
Fukuoka-shi Hakata-ku
Kijima Kids Clinic
RECRUITING
Higashiokitama-gun
Terada Internal Medicine and Respiratory Department
RECRUITING
Himeji-shi
Toda Internal Medicine and Neurology
RECRUITING
Hyōgo
Rinku General Medical Center
RECRUITING
Izumisano
Kamezawa Clinic
RECRUITING
Kasugai-shi
Medical Corporation Hosoda Clinic
RECRUITING
Katsushika-ku
Medical corporation Kojinkai Takahashi Internal Medicine
RECRUITING
Kawasaki-shi
Social Medical Corporation the Chiyukai foundation Shin Komonji Hospital
RECRUITING
Kitakyushu-shi
Medical corporation Aimeikai Morizono internal medicine
RECRUITING
Kitakyushu-shi Yahatanishi-ku
Medical Corporation Shirayurikai Swing Building Nozaki Clinic
RECRUITING
Musashino
Hosokawa Surgical Clinic
RECRUITING
Nagoya-shi Nakamura-ku
Nogata Clinic
RECRUITING
Nakano-ku
Noguchi Internal Medicine Clinic
RECRUITING
Nakano-ku
Social medical corporation Keiwakai Nishioka Hospital
RECRUITING
Sapporo-shi Toyohira-ku
Mih Clinic Yoyogi
RECRUITING
Shibuya-ku
Sato Clinic
RECRUITING
Shibuya-ku
Medical corporation Hiroyukai Yotsuya Internal Medicine
RECRUITING
Shinjuku-ku
Shiwa Central Pediatrics
RECRUITING
Shiwa-gun
Yoshida Clinic
RECRUITING
Suginami-ku
Shizuka Clinic
RECRUITING
Takasaki-shi
Sekino Hospital
RECRUITING
Toshima-ku
Tsuchiura Beryl Clinic
RECRUITING
Tsuchiura-shi
Gajyumaru Clinic Tsukuba
RECRUITING
Tsukuba
South Africa
Newtown Clinical Research Centre
RECRUITING
Johannesburg
Be Part Yoluntu Centre
RECRUITING
Paarl
Contact Information
Primary
Shionogi Clinical Trials Administrator Clinical Support Help Line
Shionogiclintrials-admin@shionogi.co.jp
800-849-9707
Time Frame
Start Date:2025-12-11
Estimated Completion Date:2026-12-30
Participants
Target number of participants:192
Treatments
Experimental: S-337395 High Dose
Participants will receive a high dose of S-337395 twice daily (BID) orally for up to 5 days.
Experimental: S-337395 Low Dose
Participants will receive a low dose of S-337395 BID orally for up to 5 days.
Placebo_comparator: Placebo
Participants will receive matching placebo BID orally for 5 days.