Actively Recruiting
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
Led by Shionogi · Updated on 2026-05-06
192
Participants Needed
68
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New or worsening symptoms of viral respiratory infection within 72 hours prior to randomization, including fever, nasal congestion, nasal discharge, sore throat, cough, sputum production, shortness of breath, or wheezing
- Diagnosed with RSV infection preferably by rapid PCR or molecular test
- At least one risk factor for severe RSV disease: 75 years or older, symptomatic chronic lung disease requiring treatment, or symptomatic chronic cardiovascular disease requiring treatment
- Medically stable apart from RSV disease based on history, physical exam, vital signs, and ECG at screening
You will not qualify if you...
- Hospitalized or expected to be hospitalized within 24 hours of screening
- Considered immunocompromised due to medical condition or therapy such as chemotherapy, radiation, stem cell or organ transplant
- Known allergies or intolerance to S-337395 or placebo components
- Suspected or known severe kidney impairment
- Any medical or psychiatric condition making participation unsuitable or interfering with study evaluation
- Received RSV treatment within 14 days before screening
- Receiving chemotherapy or immunotherapy for cancer
- Received RSV vaccination within 7 days before screening
- Confirmed SARS-CoV-2 or influenza infection within 28 days before screening
- Any other confirmed significant respiratory infection at or within 28 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 68 locations
1
LA Universal Research Center, Inc.
Los Angeles, California, United States, 900057-4040
Actively Recruiting
2
Med Partnes, Inc - Elligo- PPDS
Toluca Lake, California, United States, 91602-3457
Actively Recruiting
3
Hope Clinical Trials - 3970 W Flagler St.
Coral Gables, Florida, United States, 33134-1642
Actively Recruiting
4
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, United States, 33157
Actively Recruiting
5
Doral Medical Research
Hialeah, Florida, United States, 33016-1897
Actively Recruiting
6
Southern Clinical Research
Miami, Florida, United States, 33125-4106
Actively Recruiting
7
LCC Medical Research - Miami - BTC - PPDS
Miami, Florida, United States, 33126
Actively Recruiting
8
Nuren Medical and Research Center
Miami, Florida, United States, 33144-2069
Actively Recruiting
9
Continental Clinical Research, LLC
Miami, Florida, United States, 33144-4273
Actively Recruiting
10
Dynamic Medical Research, LLC - Miami
Miami, Florida, United States, 33144
Actively Recruiting
11
Miami Clinical Research, LLP.
Miami, Florida, United States, 33155
Actively Recruiting
12
Reed Medical Research
Miami, Florida, United States, 33176-8709
Actively Recruiting
13
Palm Springs Community Health Center
Miami Lakes, Florida, United States, 33014-2266
Actively Recruiting
14
Oceanic Research Group, LLC
North Miami Beach, Florida, United States, 33169-5513
Actively Recruiting
15
CDC Research Institute, LLC
Port Saint Lucie, Florida, United States, 34952-7539
Actively Recruiting
16
Cordova Research Insittute
Sweetwater, Florida, United States, 33182
Actively Recruiting
17
Better Life Clinical Research LLC
Tampa, Florida, United States, 33607
Actively Recruiting
18
Research Bay,Inc.
Tampa, Florida, United States, 33607
Actively Recruiting
19
Santos Research Center - 5927 Webb Rd
Tampa, Florida, United States, 33615-3219
Actively Recruiting
20
Angels Clinical Research Institute Tampa-Palm Springs
Tampa, Florida, United States, 336214-2869
Actively Recruiting
21
Covenant Pulmonary Criticial Care and Research Ins
East Point, Georgia, United States, 30344-3604
Actively Recruiting
22
Clay Platte Family Medicine - CCT Research
Kansas City, Missouri, United States, 64151-2411
Actively Recruiting
23
Prime Global Research, Inc.
The Bronx, New York, United States, 10456-2102
Actively Recruiting
24
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
25
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
26
Epic Medical Research - Chickasha
Chickasha, Oklahoma, United States, 73018-2738
Actively Recruiting
27
Rhode Island Hospital
Providence, Rhode Island, United States, 02903-4923
Actively Recruiting
28
Epic Med. Research LLC, DeSoto
DeSoto, Texas, United States, 75115-2043
Actively Recruiting
29
SMS Clinical Research, LLC - 400 W. Kearney St
Mesquite, Texas, United States, 751497
Actively Recruiting
30
Clinical Research Partners LLC
Richmond, Virginia, United States, 23226-3786
Actively Recruiting
31
Frontier Clinical Research Waterfront
Morgantown, West Virginia, United States, 26501
Actively Recruiting
32
Medical Center Hera EOOD, Montana
Montana, Sofia, Bulgaria, 3400
Actively Recruiting
33
Multiprofile Hospital For Active Treatment Dr Tota Venkova - PRATIA - PPDS
Gabrovo, Bulgaria, 5300
Actively Recruiting
34
MCpulmo-2018 Ltd
Haskovo, Bulgaria, 6300
Actively Recruiting
35
Medical Center Hera EOOD
Sofia, Bulgaria, 1510
Actively Recruiting
36
Kamezawa Clinic
Kasugai-Shi, Aiti, Japan, 0568-56-5050
Actively Recruiting
37
Hosokawa Surgical Clinic
Nagoya-Shi Nakamura-Ku, Aiti, Japan, 052-481-9921
Actively Recruiting
38
Doi Clinic
Chikushino-shi, Fukuoka, Japan, 092-926-7415
Actively Recruiting
39
Irie Clinic
Fukuoka, Fukuoka, Japan, 092-651-4521
Actively Recruiting
40
Tomita Internal Medicine Clinic
Fukuoka-Shi Chuo-Ku, Fukuoka, Japan, 092-707-2103
Actively Recruiting
41
PS Clinic
Fukuoka-Shi Hakata-Ku, Fukuoka, Japan, 092-283-7777
Actively Recruiting
42
Medical corporation Aimeikai Morizono internal medicine
Kitakyushu-Shi Yahatanishi-Ku, Fukuoka, Japan, 093-611-5335
Actively Recruiting
43
Social Medical Corporation the Chiyukai foundation Shin Komonji Hospital
Kitakyushu-Shi, Fukuoka, Japan, 093-391-1001
Actively Recruiting
44
Shizuka Clinic
Takasaki-shi, Gunma, Japan, 027-370-0777
Actively Recruiting
45
Social medical corporation Keiwakai Nishioka Hospital
Sapporo-Shi Toyohira-Ku, Hokkaidô, Japan, 011-853-8322
Actively Recruiting
46
Terada Internal Medicine and Respiratory Department
Himeji-shi, Hyôgo, Japan, 079-285-0111
Actively Recruiting
47
Tsuchiura Beryl Clinic
Tsuchiura-Shi, Ibaraki, Japan, 029-835-3002
Actively Recruiting
48
Gajyumaru Clinic Tsukuba
Tsukuba, Ibaraki, Japan, 029-893-4159
Actively Recruiting
49
Shiwa Central Pediatrics
Shiwa-gun, Iwate, Japan, 019-672-1110
Actively Recruiting
50
Medical corporation Kojinkai Takahashi Internal Medicine
Kawasaki-Shi, Kanagawa, Japan, 044-740-2717
Actively Recruiting
51
Ebino Centro Clinic
Ebino, Miyazaki, Japan, 0984-33-5777
Actively Recruiting
52
Rinku General Medical Center
Izumisano, Osaka, Japan, 072-469-3111
Actively Recruiting
53
Yamaichi Building Internal Medicine Clinic
Adachi-Ku, Tokyo, Japan, 03-884-8888
Actively Recruiting
54
Medical Corporation Hosoda Clinic
Katsushika-ku, Tokyo, Japan, 03-3657-3430
Actively Recruiting
55
Medical Corporation Shirayurikai Swing Building Nozaki Clinic
Musashino, Tokyo, Japan, 0422-36-3534
Actively Recruiting
56
Nogata Clinic
Nakano-ku, Tokyo, Japan, 03-3389-2201
Actively Recruiting
57
Noguchi Internal Medicine Clinic
Nakano-Ku, Tokyo, Japan, 03-3926-0007
Actively Recruiting
58
Sato Clinic
Shibuya-Ku, Tokyo, Japan, 03-5447-2477
Actively Recruiting
59
Mih Clinic Yoyogi
Shibuya-Ku, Tokyo, Japan, 03-6276-5385
Actively Recruiting
60
Medical corporation Hiroyukai Yotsuya Internal Medicine
Shinjuku-Ku, Tokyo, Japan, 03-5368-0675
Actively Recruiting
61
Yoshida Clinic
Suginami-ku, Tokyo, Japan, 03-5347-7300
Actively Recruiting
62
Sekino Hospital
Toshima-Ku, Tokyo, Japan, 03-3986-5501
Actively Recruiting
63
Kijima Kids Clinic
Higashiokitama-gun, Yamagata, Japan, 0238-54-0135
Actively Recruiting
64
Toda Internal Medicine and Neurology
Hyōgo, Japan, 078-947-5575
Actively Recruiting
65
Alergo-Med Osrodek Badan Klinicznych sp z o.o
Tarnów, Lesser Poland Voivodeship, Poland, 33-100
Actively Recruiting
66
Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
Actively Recruiting
67
Newtown Clinical Research Centre
Johannesburg, Gauteng, South Africa, 2001
Actively Recruiting
68
Be Part Yoluntu Centre
Paarl, Western Cape, South Africa, 7655
Actively Recruiting
Research Team
S
Shionogi Clinical Trials Administrator Clinical Support Help Line
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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