A study to determine if the study medicine called Sisunatovir is safe and prevents severe illness in adults with Respiratory Syncytial Virus infection.
- Conditions
- Health Condition 1: J22- Unspecified acute lower respiratory infection
- Registration Number
- CTRI/2024/04/065929
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
(1) Participants aged 18 years or older at screening.
(2) Diagnosis of RSV infection collected within 5 days prior to randomization.
(3) 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.
(4) 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
1. Any medical (eg, confirmed concurrent active systemic infection other than RSV
including bacterial, fungal, or viral) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality 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.
2. Diagnosis of viral respiratory infections other than RSV including influenza and SARSCoV-2, within 7 days prior to randomization. A negative test for SARS-CoV-2 and
influenza is required within 7 days prior to randomization.
3. Current need for hospitalization or anticipated need for hospitalization for any reason to provide inpatient/acute care within 24 hours after randomization in the clinical opinion of the site investigator.
4. Known history or has risk factors for QT prolongation or Torsades de Pointes (eg,
organic heart disease, hypokalemia, hypomagnesaemia, congenital long QT syndrome) or
congenital deafness, family history of long QT syndrome or unexplained sudden death
OR a standard 12-lead ECG with QTcF =450 ms.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 onsetTimepoint: 28 days
- Secondary Outcome Measures
Name Time Method Mean number of days alive & free from hospital stay (hospital-free days) through Day 28.Timepoint: 28 days;Proportion of participants with progression or development of Lower Respiratory Tract Infection (LRTI) through Day 10Timepoint: 10 days;Proportion of participants with resolution of LRTI at Day 15Timepoint: 15 days;Proportion of participants with Respiratory Syncytial Virus (RSV)-related visits or death from any cause through Day 28.daysTimepoint: 28;Proportion of participants with RSV-related hospitalization or death from any cause through Day 28.Timepoint: 10 days & 28 days