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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Shionogi
Study ID
NCT07214571
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Respiratory Syncytial Virus Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • S-337395 — DRUG
    S-337395 will be administered per schedule specified in the arm description.
  • Placebo — DRUG
    Placebo matched to S-337395 will be administered per schedule specified in the arm description.

Study Details

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.

Key Dates

Start date
Dec 11, 2025
Status verified
Jun 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change From Baseline in RSV Ribonucleic Acid (RNA) Load by Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) (Nasopharyngeal Swab) at Day 2 [ Time Frame: Baseline, Day 2 ]

Central Contacts

  • Shionogi Clinical Trials Administrator Clinical Support Help Line
    800-849-9707
    [email protected]

Locations (33)

FacilityCityStateZIPSite coordinators
LA Universal Research Center, Inc.Los AngelesCalifornia900057-4040-
Med Partnes, Inc - Elligo- PPDSToluca LakeCalifornia91602-3457-
Hope Clinical Trials - 3970 W Flagler St.Coral GablesFlorida33134-1642-
Beautiful Minds Clinical Research CenterCutler BayFlorida33157-
Doral Medical ResearchHialeahFlorida33016-1897-
Continental Clinical Research, LLCMiamiFlorida33144-4273-
Dynamic Medical Research, LLC - MiamiMiamiFlorida33144-
Global Health Clinical TrialsMiamiFlorida33135-2961-
LCC Medical Research - Miami - BTC - PPDSMiamiFlorida33126-
Miami Clinical Research, LLP.MiamiFlorida33155-
Nuren Medical and Research CenterMiamiFlorida33144-2069-
Reed Medical ResearchMiamiFlorida33176-8709-
Southern Clinical ResearchMiamiFlorida33125-4106-
Palm Springs Community Health CenterMiami LakesFlorida33014-2266-
Oceanic Research Group, LLCNorth Miami BeachFlorida33169-5513-
CDC Research Institute, LLCPort Saint LucieFlorida34952-7539-
Cordova Research InsittuteSweetwaterFlorida33182-
Angels Clinical Research Institute Tampa-Palm SpringsTampaFlorida336214-2869-
Better Life Clinical Research LLCTampaFlorida33607-
Research Bay,Inc.TampaFlorida33607-
Santos Research Center - 5927 Webb RdTampaFlorida33615-3219-
Covenant Pulmonary Criticial Care and Research InsEast PointGeorgia30344-3604-
Clay Platte Family Medicine - CCT ResearchKansas CityMissouri64151-2411-
NYC Health + Hospitals/Lincoln Medical Center - BRANY - PPDSThe BronxNew York10451-
Prime Global Research, Inc.The BronxNew York10456-2102-
Progressive Medicine of the Triad, LLCWinston-SalemNorth Carolina27103-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Epic Medical Research - ChickashaChickashaOklahoma73018-2738-
Rhode Island HospitalProvidenceRhode Island02903-4923-
Epic Med. Research LLC, DeSotoDeSotoTexas75115-2043-
SMS Clinical Research, LLC - 400 W. Kearney StMesquiteTexas751497-
Clinical Research Partners LLCRichmondVirginia23226-3786-
Frontier Clinical Research WaterfrontMorgantownWest Virginia26501-

Find similar trials in Los Angeles, CA

By research site
LA Universal Research Center, Inc.· Los Angeles, CAMed Partnes, Inc - Elligo- PPDS· Toluca Lake, CAHope Clinical Trials - 3970 W Flagler St.· Coral Gables, FLBeautiful Minds Clinical Research Center· Cutler Bay, FLDoral Medical Research· Hialeah, FLContinental Clinical Research, LLC· Miami, FL

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