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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
S-337395 High Dose 		Participants will receive a high dose of S-337395 twice daily (BID) orally for up to 5 days.
  • Drug: S-337395
    S-337395 will be administered per schedule specified in the arm description.
Experimental
S-337395 Low Dose 		Participants will receive a low dose of S-337395 BID orally for up to 5 days.
  • Drug: S-337395
    S-337395 will be administered per schedule specified in the arm description.
Placebo Comparator
Placebo 		Participants will receive matching placebo BID orally for 5 days.
  • Drug: Placebo
    Placebo matched to S-337395 will be administered per schedule specified in the arm description.

Recruiting Locations

LA Universal Research Center, Inc.
Los Angeles, California 900057-4040

Med Partnes, Inc - Elligo- PPDS
Toluca Lake, California 91602-3457

Hope Clinical Trials - 3970 W Flagler St.
Coral Gables, Florida 33134-1642

Beautiful Minds Clinical Research Center
Cutler Bay, Florida 33157

Doral Medical Research
Hialeah, Florida 33016-1897

Southern Clinical Research
Miami, Florida 33125-4106

LCC Medical Research - Miami - BTC - PPDS
Miami, Florida 33126

Global Health Clinical Trials
Miami, Florida 33135-2961

Nuren Medical and Research Center
Miami, Florida 33144-2069

Continental Clinical Research, LLC
Miami, Florida 33144-4273

Miami Clinical Research, LLP.
Miami, Florida 33155

Reed Medical Research
Miami, Florida 33176-8709

Palm Springs Community Health Center
Miami Lakes, Florida 33014-2266

Oceanic Research Group, LLC
North Miami Beach, Florida 33169-5513

CDC Research Institute, LLC
Port Saint Lucie, Florida 34952-7539

Cordova Research Insittute
Sweetwater, Florida 33182

Better Life Clinical Research LLC
Tampa, Florida 33607

Research Bay,Inc.
Tampa, Florida 33607

Santos Research Center - 5927 Webb Rd
Tampa, Florida 33615-3219

Angels Clinical Research Institute Tampa-Palm Springs
Tampa, Florida 336214-2869

Covenant Pulmonary Criticial Care and Research Ins
East Point, Georgia 30344-3604

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215

Clay Platte Family Medicine - CCT Research
Kansas City, Missouri 64151-2411

NYC Health + Hospitals/Lincoln Medical Center - BRANY - PPDS
The Bronx, New York 10451

Prime Global Research, Inc.
The Bronx, New York 10456-2102

Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina 27103

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

Epic Medical Research - Chickasha
Chickasha, Oklahoma 73018-2738

Rhode Island Hospital
Providence, Rhode Island 02903-4923

Epic Med. Research LLC, DeSoto
DeSoto, Texas 75115-2043

SMS Clinical Research, LLC - 400 W. Kearney St
Mesquite, Texas 751497

Clinical Research Partners LLC
Richmond, Virginia 23226-3786

Frontier Clinical Research Waterfront
Morgantown, West Virginia 26501

More Details

Status
Recruiting
Sponsor
Shionogi

Study Contact

Shionogi Clinical Trials Administrator Clinical Support Help Line
800-849-9707
Shionogiclintrials-admin@shionogi.co.jp

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.