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

Shionogi

Status and phase: Enrolling; Phase 2

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: Placebo; Drug: S-337395

Study type: Interventional

Funder types: Industry

Identifiers

NCT07214571

2402T1432

Details and patient eligibility

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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192 participants in 3 patient groups, including a placebo group

S-337395 High Dose

Experimental group

Description:

Participants will receive a high dose of S-337395 twice daily (BID) orally for up to 5 days.

Treatment:

Drug: S-337395

S-337395 Low Dose

Experimental group

Description:

Participants will receive a low dose of S-337395 BID orally for up to 5 days.

Treatment:

Drug: S-337395

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo BID orally for 5 days.

Treatment:

Drug: Placebo