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

ConditionRespiratory Syncytial Virus Infections
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShionogi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

≥ 75 years of age;

Chronic lung disease that is symptomatic and requiring chronic treatment; and

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

192 Participants
are divided into 3 treatment groups
Group A: S-337395 High DoseExperimental treatment 1 intervention
Group B: S-337395 Low DoseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Time frame
Baseline, Day 4
3

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

Time frame
Baseline, Day 6

Secondary outcomes

1

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

Time frame
Day 1 up to Day 28
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shionogi

Lead sponsor

Source ClinicalTrials.gov
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