A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection

JRCT ID: jRCT2031230632

Registered date:14/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Respiratory Syncytial Virus Infection
• Date of first enrollment: 05/01/2024
• Target sample size: 2715
• Study type: Interventional

Intervention(s)

Drug: Sisunatovir
Participants will receive tablets from Day 1 to Day 5
Drug: Placebo
Participants will receive matching placebo tablets from Day 1 to Day 5

Outcome(s)

Primary Outcome

Primary Outcome Measures :
1.Proportion of participants with Respiratory Syncytial Virus (RSV)-related hospitalization or death from any cause through Day 28, among patients treated <=3 days after RSV symptom onset [ Time Frame: 28 days ]

Secondary Outcome

Secondary Outcome Measures :
1.Proportion of participants with RSV-related hospitalization or death from any cause through Day 28. [ Time Frame: 10 days and 28 days ]
2.Proportion of participants with Respiratory Syncytial Virus (RSV)-related visits or death from any cause through Day 28. [ Time Frame: 28 days ]
3.Proportion of participants with progression, development or resolution of Lower Respiratory Tract Infection (LRTI) through Day 10 [ Time Frame: 10 days ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

Inclusion Criteria:
*Participants aged 18 years or older at screening.
*Diagnosis of RSV infection collected within 5 days prior to randomization.
*New onset or worsening (if present chronically) of at least one of the following signs and/or symptoms consistent with a viral acute respiratory infection (ARI), within 5 days prior to randomization: nasal congestion, nasal discharge, sore throat, cough, sputum production, shortness of breath, or wheezing.
*Has at least 1 of the following characteristics or underlying medical conditions: a) 65 years of age or older b) Chronic lung disease, c) Heart failure, d) Immunosuppressive disease/condition or immune-weakening medications

Exclude criteria

Exclusion Criteria:
*Any medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study or interfere with the evaluation of response to the study intervention.
*Diagnosis of viral respiratory infections other than RSV including influenza and SARS-CoV-2
*Current need for hospitalization or anticipated need for hospitalization for any reason to provide inpatient/acute care within 24 hours after randomization
*Known history or has risk factors for QT prolongation or Torsades de Pointes or congenital deafness, family history of long QT syndrome or unexplained sudden death, or a standard 12-lead ECG with QTcF >=450 ms
*Has hypersensitivity to or other contraindication to any of the components of the study interventions, as determined by the investigator.

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT06079320