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

Phase 2RecruitingNCT07214571

Shionogi192 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

192

Conditions

Respiratory Syncytial Virus Infections

Interventions

S-337395DRUG

S-337395 will be administered per schedule specified in the arm description.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (64)

Outcomes

Primary Outcomes

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

Change From Baseline in RSV RNA Load by qRT-PCR (Nasopharyngeal Swab) at Day 4

Time frame: Baseline, Day 4

Change From Baseline in RSV RNA Load by qRT-PCR (Nasopharyngeal Swab) at Day 6

Time frame: Baseline, Day 6

Secondary Outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame: Day 1 up to Day 28

Change From Baseline in Severity of RSV Respiratory Symptom Score Based on the Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Respiratory Symptom Subscale (RiiQ-RSS)

Time frame: Baseline up to Day 6

Change From Baseline in Severity of RSV Systemic Symptoms Score Based on the RiiQ Systemic Symptom Subscale (RiiQ-SSS)

Time frame: Baseline up to Day 6

Change From Baseline in Severity of RSV Total Symptoms Score Based on the Combined RiiQ RSS and RiiQ-SSS

Time frame: Baseline up to Day 6

Time to First Resolution of All Respiratory RSV-related Symptoms Based on the RiiQ-RSS

Time frame: Baseline up to Day 6

Time to Sustained (2 Consecutive Days) Resolution of All Respiratory RSV-related Symptoms Based on the RiiQ-RSS

Time frame: Baseline up to Day 6

Central Contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line

CONTACT

800-849-9707 Shionogiclintrials-admin@shionogi.co.jp

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

LA Universal Research Center, Inc.

Los Angeles, California, United States

RECRUITING

Med Partnes, Inc - Elligo- PPDS

Toluca Lake, California, United States

RECRUITING

Hope Clinical Trials - 3970 W Flagler St.

Coral Gables, Florida, United States

RECRUITING

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, United States

RECRUITING

Doral Medical Research

Hialeah, Florida, United States

RECRUITING

Southern Clinical Research

Miami, Florida, United States

RECRUITING

LCC Medical Research - Miami - BTC - PPDS

Miami, Florida, United States

RECRUITING

Nuren Medical and Research Center

Miami, Florida, United States

RECRUITING

Continental Clinical Research, LLC

Miami, Florida, United States

RECRUITING

Dynamic Medical Research, LLC - Miami

Miami, Florida, United States

RECRUITING

...and 54 more locations

Time to First Resolution of All Systemic RSV-related Symptoms Based on the RiiQ-SSS

Time frame: Baseline up to Day 6

Time to Sustained Resolution of All Systemic RSV-related Symptoms Based on the RiiQ-SSS

Time frame: Baseline up to Day 6

Time to First Resolution of All Respiratory and Systemic RSV-related Symptoms Based on the Combined RiiQ RSS and RiiQ-SSS

Time frame: Baseline up to Day 6

Time to Sustained Resolution of All Respiratory and Systemic RSV-related Symptoms Based on the Combined RiiQ RSS and RiiQ-SSS

Time frame: Baseline up to Day 6

Time to First Resolution of Each Separate RSV-related Symptom Based on the RiiQ Symptom Subscale

Time frame: Baseline up to Day 6

Time to Sustained Resolution of Each Separate RSV-related Symptom Based on the RiiQ Symptom Subscale

Time frame: Baseline up to Day 6

Change From Baseline in RSV RNA Load

Time frame: Baseline up to Day 6

Area Under the Curve (AUC) of Change From Baseline in RSV RNA Load

Time frame: Baseline up to Day 6

Time to the First Negative RSV RNA Load by qRT-PCR

Time frame: Baseline up to Day 6

Time to Sustained Negative RSV RNA Load by qRT-PCR

Time frame: Baseline up to Day 6

Percentage of Participants With Negative RSV RNA Load by qRT-PCR

Time frame: Baseline up to Day 6

Time to the First RSV RNA Load <Lower Limit of Quantitation (LLOQ)

Time frame: Baseline up to Day 6

Time to Sustained RSV RNA Load <LLOQ

Time frame: Baseline up to Day 6

Percentage of Participants With RSV RNA Load <LLOQ

Time frame: Baseline up to Day 6

Change From Baseline in Infectious Titer

Time frame: Baseline up to Day 6

AUC of Change From Baseline in Infectious Titer

Time frame: Baseline up to Day 6

Time to the First Negative RSV Infectious Titer

Time frame: Baseline up to Day 6

Time to Sustained Negative RSV Infectious Titer

Time frame: Baseline up to Day 6

Percentage of Participants With Negative RSV Infectious Titer

Time frame: Baseline up to Day 6

Time to the First RSV Infectious Titer <LLOQ

Time frame: Baseline up to Day 6

Time to Sustained RSV Infectious Titer <LLOQ

Time frame: Baseline up to Day 6

Percentage of Participants With RSV Infectious Titer <LLOQ

Time frame: Baseline up to Day 6

Plasma Concentration of S-337395 After Repeated Oral Doses of S-337395

Time frame: Baseline up to Day 6

Plasma Concentration of S-337395 12 and 24 Hours After the First Dose and the Last Dose (C12 and C24)

Time frame: 12 hours and 24 hours after first dose (Day 2) and last dose (Day 6)