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 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 18
- 主要终点
- Number of Participants With Respiratory Syncytial Virus (RSV) Related Hospitalization or Death From Any Cause Through Day 28
研究概览
简要总结
The purpose of this study is to learn about the safety and effects of sisunatovir. Sisunatovir is studied for the possible treatment of Respiratory Syncytial Virus (RSV). RSV is a virus that causes lung infections with cold-like symptoms, but it can cause severe illness in some people. Sisunatovir is studied in adults:
- who are not admitted to the hospital and
- who have high chances of having a severe illness from RSV infection.
This study is seeking participants who:
- Are confirmed to have RSV.
- Have symptoms of a lung infection.
- Are 18 years of age or older.
- Have one or more of the following which increases the chances of RSV illness:
- A long-term lung disease.
- heart failure.
- a condition that weakens the immune system.
- Are 65 years of age or older and do not have any of the conditions above
Half of the participants in this study will receive sisunatovir. The other half will receive a placebo for 5 days. Placebo looks same like the study medicine but does not have any medication. Both sisunatovir and placebo will be taken by mouth. The study will compare the experiences of people receiving sisunatovir to those of the people who do not. This will help decide if sisunatovir is safe and effective.
Participants will attend about 8-10 study visits over 5 weeks. During this time, they will have:
- visits at the study clinic,
- blood work,
- swabs of the nose,
- questionnaires,
- a follow-up phone call.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be assigned to receive study intervention according to the assigned treatment group from the randomization scheme. Investigators will remain blinded to each participant's assigned study intervention until all participants complete treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Any clinically significant ECG abnormality in the pre-dose ECG that, per investigator judgement, may affect participant safety
- •Has hypersensitivity to or other contraindication to any of the components of the study interventions, as determined by the investigator.
研究组 & 干预措施
Sisunatovir
干预措施: Sisunatovir (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Respiratory Syncytial Virus (RSV) Related Hospitalization or Death From Any Cause Through Day 28
时间窗: From Day 1 (start of study intervention) up to Day 28
RSV related hospitalization included a specialized acute medical care unit within an assisted living facility or nursing home.
次要结局
- Mean Number of RSV Related Days in Intensive Care Unit (ICU) Through Day 28(From Day 1 (start of study intervention) up to Day 28)
- Mean Number of RSV Related Days in Hospital Through Day 28(From Day 1 (start of study intervention) up to Day 28)
- Number of Participants With RSV-Related Visits (Urgent Care/ Emergency Department (ED)/Hospital) or Death From Any Cause Through Day 28(From Day 1 (start of study intervention) up to Day 28)
- Number of Participants With Progression of Lower Respiratory Tract Infection (LRTI) Through Day 10(From randomization on Day 1 up to Day 10)
- Number of Participants With Development of LRTI Through Day 10(From randomization on Day 1 up to Day 10)
- Number of Participants With Resolution of LRTI at Day 15(Day 15)
- Mean Number of Hospital Free Days Through Day 28(From Day 1 (start of study intervention) up to Day 28)
- Number of Participants With Progression of LRTI Through Days 3, 5, 15 and 28(From randomization on Day 1 up to Days 3, 5, 15 and 28)
- Number of Participants With Development of LRTI Through Days 3, 5, 15 and 28(From randomization on Day 1 up to Days 3, 5, 15 and 28)
- Number of Participants With Resolution of LRTI at Days 3, 5, 10 and 28(At Days 3, 5, 10 and 28)
- Number of Participants With Improvement of LRTI at Days 3, 5, 10, 15 and 28(At Days 3, 5, 10, 15 and 28)
- Number of Participants With a Clinical Response of Improvement or Resolution at Days 5, 10, 15, and 28(At Days 5, 10, 15, and 28)
- Number of Participants With Undetectable RSV Viral Load at Days 3, 5, 10, 15 and 28(At Days 3, 5, 10, 15, and 28)
- Change From Baseline in Log10 Transformed Total RSV Viral Load at Days 3, 5, 10, 15 and 28(Baseline (within 1 hour post start of study intervention on Day 1) and Days 3, 5, 10, 15, and 28)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) Through Day 35(From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35))
- Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) Through Day 35(From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35))
- Plasma Concentrations of Sisunatovir at Days 3 and 5(Anytime between 3 to 8 hours post dose on Day 3, and pre-dose on Day 5)