An interventional phase 2/3, adaptive, multi-Center, randomized, double-blind study to investigate efficacy and safety of oral Sisunatovir compared with Placebo in non-hospitalized symptomatic adults with Respiratory Syncytial Virus infection who are at risk of progression to severe illness. - NI

Pfizer Inc.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•(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.

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