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.
试验速览
- 阶段
- 2/3 期
- 状态
- Other (Terminated)
- 发起方
- Pfizer Inc.
- 入组人数
- 4,075
- 试验地点
- 11
- 主要终点
- 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
研究概览
简要总结
| Respiratory syncytial |
| virus (RSV) is a worldwide cause of respiratory infection that causes |
| significant morbidity and mortality among vulnerable patients (young |
| children, immunocompromised, cardiopulmonary comorbidities, and elderly). The |
| virus is highly infectious and transmitted through respiratory secretions via |
| close contact with infected individuals, droplets, or contaminated surfaces. |
| The virus circulates during the colder months, resulting in geographically |
| specific RSV seasons. The 2 major subtypes of RSV (A and B) cause similar |
| disease and can co-circulate. |
Older adults and individuals affected by cardiopulmonary comorbidities or compromised immune system are at increased risk of poor clinical outcomes following respiratory syncytial virus (RSV) infection. Currently, no oral treatment is approved for this indication.
The purpose of this trial is to investigate the safety and efficacy of orally administered sisunatovir, a potent inhibitor of the RSV F protein that prevents entry into the host cells, for the treatment of RSV infection in non-hospitalized adults at risk of severe illness.
All objectives, endpoints, and estimands will be evaluated in non-hospitalized adults who are infected with RSV and are at high risk of severe illness. The treatment effect is evaluated in the population of study participants who are randomized and treated irrespective of their compliance to the planned course of treatment or use of concomitant medications. The primary analysis is restricted to adults treated ≤3 days after RSV symptom onset. All key secondary endpoints are analyzed regardless of duration from RSV symptom onset to initiation of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •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.
- •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.
- •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.
- •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.
结局指标
主要结局
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
时间窗: 28 days
次要结局
- Proportion of participants with RSV-related hospitalization or death from any cause through Day 28.(10 days & 28 days)
- Proportion of participants with Respiratory Syncytial Virus (RSV)-related visits or death from any cause through Day 28.days(28)
- Proportion of participants with progression or development of Lower Respiratory Tract Infection (LRTI) through Day 10(10 days)
- Proportion of participants with resolution of LRTI at Day 15(15 days)
- Mean number of days alive & free from hospital stay (hospital-free days) through Day 28.(28 days)