Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07214571

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease | DecenTrialz