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New RSV drug trial aims to protect vulnerable adults

NCT ID NCT07214571

Disease control Sponsor: Shionogi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 6 times

Summary

This study tests an experimental antiviral drug called S-337395 in adults with RSV who are at high risk for severe illness. Participants must have symptoms for less than 72 hours and a confirmed RSV infection. The goal is to see if the drug can lower the amount of virus in the body and ease symptoms compared to a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 192 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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: 1. ≥ 75 years of age; 2. Chronic lung disease that is symptomatic and requiring chronic treatment; and 3. 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. Key Exclusion Criteria: * Hospitalized or expected to be hospitalized within 24 hours of screening. * Is considered by the investigator to be immunocompromised, due to an underlying medical condition or medical therapy, chemotherapy, radiation, stem cell or solid organ transplant. * Has known allergies, hypersensitivity, or intolerance to S-337395 or to any of the excipients of the S-337395 or placebo formulation. * Suspicion or known severe renal impairment. * Any other medical or psychiatric condition making the participant unsuitable for the current study or interfering with the evaluation of response to the study intervention in the opinion of the investigator/subinvestigator. * Has received a therapy intended to treat RSV infection within 14 days prior to screening. * Is receiving chemotherapy or immunotherapy for malignancy. * Has received RSV vaccination within 7 days prior to screening. * Has had either confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or influenza infection (test was positive) during the 28 days prior to screening. * Has any other confirmed clinically relevant respiratory infection by any pathogen at, or within 28 days of screening. Note: Other protocol-specified inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease viral infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory syncytial virus infections

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    83 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AES - AS - Clinica Mayo de Urgencias

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina

  • AES - AS - Glenny Corp. S.A. Buenos Aires

    RECRUITING

    CABA, Buenos Aires, C1430CKE, Argentina

  • Alergo-Med Osrodek Badan Klinicznych sp z o.o

    RECRUITING

    Tarnów, Lesser Poland Voivodeship, 33-100, Poland

  • Angels Clinical Research Institute Tampa-Palm Springs

    RECRUITING

    Tampa, Florida, 336214-2869, United States

  • Be Part Yoluntu Centre

    RECRUITING

    Paarl, Western Cape, 7655, South Africa

  • Beautiful Minds Clinical Research Center

    RECRUITING

    Cutler Bay, Florida, 33157, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Better Life Clinical Research LLC

    RECRUITING

    Tampa, Florida, 33607, United States

  • CDC Research Institute, LLC

    RECRUITING

    Port Saint Lucie, Florida, 34952-7539, United States

  • Central Valley Research

    RECRUITING

    Modesto, California, 95350, United States

  • Centrum Medyczne Chojnice - PRATIA - PPDS

    RECRUITING

    Chojncie, Pomeranian Voivodeship, 86-900, Poland

  • Clay Platte Family Medicine - CCT Research

    RECRUITING

    Kansas City, Missouri, 64151-2411, United States

  • Clinical Research Partners LLC

    RECRUITING

    Richmond, Virginia, 23226-3786, United States

  • Continental Clinical Research, LLC

    RECRUITING

    Miami, Florida, 33144-4273, United States

  • Cordova Research Insittute

    RECRUITING

    Sweetwater, Florida, 33182, United States

  • Covenant Pulmonary Criticial Care and Research Ins

    RECRUITING

    East Point, Georgia, 30344-3604, United States

  • DCT-McAllen Primary Care Research, LLC

    RECRUITING

    McAllen, Texas, 78503, United States

  • Doi Clinic

    RECRUITING

    Chikushino-shi, Fukuoka, 092-926-7415, Japan

  • Doral Medical Research

    RECRUITING

    Hialeah, Florida, 33016-1897, United States

  • Dynamic Medical Research, LLC - Miami

    WITHDRAWN

    Miami, Florida, 33144, United States

  • Ebino Centro Clinic

    RECRUITING

    Ebino, Miyazaki, 0984-33-5777, Japan

  • Epic Med. Research LLC, DeSoto

    RECRUITING

    DeSoto, Texas, 75115-2043, United States

  • Epic Medical Research - Chickasha

    RECRUITING

    Chickasha, Oklahoma, 73018-2738, United States

  • Frontier Clinical Research Waterfront

    RECRUITING

    Morgantown, West Virginia, 26501, United States

  • Fundación Huésped - PPDS

    RECRUITING

    CABA, Buenos Aires, C1427CEA, Argentina

  • Gajyumaru Clinic Tsukuba

    RECRUITING

    Tsukuba, Ibaraki, 029-893-4159, Japan

  • Global Health Clinical Trials

    RECRUITING

    Miami, Florida, 33135-2961, United States

  • Hope Clinical Trials - 3970 W Flagler St.

    RECRUITING

    Coral Gables, Florida, 33134-1642, United States

  • Hosokawa Surgical Clinic

    RECRUITING

    Nagoya-Shi Nakamura-Ku, Aiti, 052-481-9921, Japan

  • Instituto Médico Río Cuarto

    RECRUITING

    Río Cuarto, Córdoba Province, X5800AEV, Argentina

  • Irie Clinic

    RECRUITING

    Fukuoka, Fukuoka, 092-651-4521, Japan

  • Kamezawa Clinic

    RECRUITING

    Kasugai-Shi, Aiti, 0568-56-5050, Japan

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, Taiwan

  • Kaohsiung Veterans General Hospital

    RECRUITING

    Kaohsiung City, 813414, Taiwan

  • Kijima Kids Clinic

    RECRUITING

    Higashiokitama-gun, Yamagata, 0238-54-0135, Japan

  • LA Universal Research Center, Inc.

    RECRUITING

    Los Angeles, California, 900057-4040, United States

  • LCC Medical Research - Miami - BTC - PPDS

    RECRUITING

    Miami, Florida, 33126, United States

  • MCpulmo-2018 Ltd

    RECRUITING

    Haskovo, 6300, Bulgaria

  • Med Partnes, Inc - Elligo- PPDS

    RECRUITING

    Toluca Lake, California, 91602-3457, United States

  • Medical Center Hera EOOD

    RECRUITING

    Sofia, 1510, Bulgaria

  • Medical Center Hera EOOD, Montana

    RECRUITING

    Montana, Sofia, 3400, Bulgaria

  • Medical Center Neuromedics EOOD - 4 Veliki Preslav Str

    RECRUITING

    Veliko Tarnovo, 5005, Bulgaria

  • Medical Corporation Hosoda Clinic

    RECRUITING

    Katsushika-ku, Tokyo, 03-3657-3430, Japan

  • Medical Corporation Shirayurikai Swing Building Nozaki Clinic

    RECRUITING

    Musashino, Tokyo, 0422-36-3534, Japan

  • Medical corporation Aimeikai Morizono internal medicine

    RECRUITING

    Kitakyushu-Shi Yahatanishi-Ku, Fukuoka, 093-611-5335, Japan

  • Medical corporation Hiroyukai Yotsuya Internal Medicine

    RECRUITING

    Shinjuku-Ku, Tokyo, 03-5368-0675, Japan

  • Medical corporation Kojinkai Takahashi Internal Medicine

    RECRUITING

    Kawasaki-Shi, Kanagawa, 044-740-2717, Japan

  • Miami Clinical Research, LLP.

    RECRUITING

    Miami, Florida, 33155, United States

  • Mih Clinic Yoyogi

    RECRUITING

    Shibuya-Ku, Tokyo, 03-6276-5385, Japan

  • Multiprofile Hospital For Active Treatment Dr Tota Venkova - PRATIA - PPDS

    RECRUITING

    Gabrovo, 5300, Bulgaria

  • NYC Health + Hospitals/Lincoln Medical Center - BRANY - PPDS

    RECRUITING

    The Bronx, New York, 10451, United States

  • Newtown Clinical Research Centre

    RECRUITING

    Johannesburg, Gauteng, 2001, South Africa

  • Nogata Clinic

    RECRUITING

    Nakano-ku, Tokyo, 03-3389-2201, Japan

  • Noguchi Internal Medicine Clinic

    RECRUITING

    Nakano-Ku, Tokyo, 03-3926-0007, Japan

  • Nuren Medical and Research Center

    RECRUITING

    Miami, Florida, 33144-2069, United States

  • Oceanic Research Group, LLC

    RECRUITING

    North Miami Beach, Florida, 33169-5513, United States

  • Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik

    RECRUITING

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland

  • PS Clinic

    RECRUITING

    Fukuoka-Shi Hakata-Ku, Fukuoka, 092-283-7777, Japan

  • Palm Springs Community Health Center

    RECRUITING

    Miami Lakes, Florida, 33014-2266, United States

  • Prime Global Research, Inc.

    RECRUITING

    The Bronx, New York, 10456-2102, United States

  • Progressive Medicine of the Triad, LLC

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Reed Medical Research

    RECRUITING

    Miami, Florida, 33176-8709, United States

  • Research Bay,Inc.

    RECRUITING

    Tampa, Florida, 33607, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903-4923, United States

  • Rinku General Medical Center

    RECRUITING

    Izumisano, Osaka, 072-469-3111, Japan

  • Roodepoort Medicross Clinical Research Centre

    RECRUITING

    Princess Crossing, Roodepoort, 1724, South Africa

  • SMS Clinical Research, LLC - 400 W. Kearney St

    RECRUITING

    Mesquite, Texas, 751497, United States

  • Santos Research Center - 5927 Webb Rd

    RECRUITING

    Tampa, Florida, 33615-3219, United States

  • Sato Clinic

    RECRUITING

    Shibuya-Ku, Tokyo, 03-5447-2477, Japan

  • Sekino Hospital

    RECRUITING

    Toshima-Ku, Tokyo, 03-3986-5501, Japan

  • Shiwa Central Pediatrics

    RECRUITING

    Shiwa-gun, Iwate, 019-672-1110, Japan

  • Shizuka Clinic

    RECRUITING

    Takasaki-shi, Gunma, 027-370-0777, Japan

  • Social Medical Corporation the Chiyukai foundation Shin Komonji Hospital

    RECRUITING

    Kitakyushu-Shi, Fukuoka, 093-391-1001, Japan

  • Social medical corporation Keiwakai Nishioka Hospital

    RECRUITING

    Sapporo-Shi Toyohira-Ku, Hokkaidô, 011-853-8322, Japan

  • Southern Clinical Research

    RECRUITING

    Miami, Florida, 33125-4106, United States

  • Terada Internal Medicine and Respiratory Department

    RECRUITING

    Himeji-shi, Hyôgo, 079-285-0111, Japan

  • The Aurum Institute Rustenburg Clinical Research Site

    RECRUITING

    Rustenburg, 2999, South Africa

  • Toda Internal Medicine and Neurology

    RECRUITING

    Hyōgo, 078-947-5575, Japan

  • Tomita Internal Medicine Clinic

    RECRUITING

    Fukuoka-Shi Chuo-Ku, Fukuoka, 092-707-2103, Japan

  • Tri-Service General Hospital

    RECRUITING

    Neihu District, Taipei, 114202, Taiwan

  • Tsuchiura Beryl Clinic

    RECRUITING

    Tsuchiura-Shi, Ibaraki, 029-835-3002, Japan

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Yamaichi Building Internal Medicine Clinic

    RECRUITING

    Adachi-Ku, Tokyo, 03-884-8888, Japan

  • Yoshida Clinic

    RECRUITING

    Suginami-ku, Tokyo, 03-5347-7300, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.