Respiratory Syncytial Virus Infection
Conditions
Interventions
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
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 ] | — |
Countries
Argentina, Australia, Canada, China, India, Japan, South Africa, Taiwan, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed