A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EDP-938 in Non-hospitalized Adults With Acute Respiratory Syncytial Virus Infection Who Are at High Risk for Complications
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 166
- 主要终点
- Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms
研究概览
简要总结
This was a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed RSV infection who were at high risk for complications after RSV infection.
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
- Double (Participant, Investigator)
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
- •At least one of the following conditions that predispose them to complications after RSV infection:
- •Age ≥65 years
- •Congestive heart failure (CHF)
- •Chronic obstructive pulmonary disease (COPD)
- •The subject has a new onset of any of the following symptom(s) or worsening of pre-existing symptom(s) consistent with a respiratory tract infection no more than 72 hours prior to the administration of the first dose of study drug: feeling feverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep, body aches, sore throat, nasal congestion, cough, cough with phlegm, wheezing, or short of breath.
- •The subject reports at least 2 of the following symptoms, one of which must be reported as at least 'moderate' severity: cough, cough with phlegm, wheezing, or short of breath
- •The subject has tested positive for RSV infection using a NAAT (polymerase chain reaction [PCR] or other) on a nasal/nasopharyngeal swab sample.
- •A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug.
- •A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.
排除标准
- •The subject has an anticipated need for hospitalization within 24 hours of signing the Study ICF
- •The subject has concomitant respiratory infections that are viral (other than RSV but including influenza), bacterial, or fungal, including systemic bacterial or fungal infections, within 7 days prior to signing the Study ICF
- •The subject has a SARS-CoV-2 test result that is positive within 28 days prior to signing the Study ICF
- •The subject has COPD with spirometry results (obtained within 1 year prior to signing the Study ICF) FEV1 ≤35%
- •The subject has a known positive human immunodeficiency virus infection, active hepatitis A virus infection, chronic hepatitis B virus infection, and/or current hepatitis C virus (HCV) infection; subjects with a history of HCV infection who have achieved a documented sustained virologic response 12 weeks after completion of HCV therapy may be enrolled.
- •The subject has any of the following cardiac conditions: any congenital heart disease, congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation
- •The subject has immunocompromised status
- •The subject is living in institutional care or assisted living facility and is also receiving acute care management for any respiratory condition; Note: Independent living apartments are not considered institutional care or assisted living facility
研究组 & 干预措施
Placebo
Matching placebo, once daily
干预措施: Placebo (Drug)
EDP-938
EDP-938 800 mg, once daily
干预措施: EDP-938 (Drug)
结局指标
主要结局
Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms
时间窗: Day 1 through Day 33
Time to Resolution of RSV Lower Respiratory Tract Disease (LRTD) Symptoms
时间窗: Day 1 through Day 33
Resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm\[sputum\]) as assessed by RiiQTM Scale Score is zero or 1. Time to resolution of LRTD symptoms is calculated as: date/time of resolution - date/time of first dose with conversion to days.
Time to Complete Resolution of LRTD Symptoms for the mITT Population
时间窗: Day 1 through Day 33
Complete resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm\[sputum\]) as assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale Score is zero. Time to complete resolution of LRTD symptoms is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.
Time to Complete Resolution of LRTD Symptoms for the HR3 Population
时间窗: Day 1 through Day 33
Complete resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm\[sputum\]) as assessed by RiiQTM Scale Score is zero. Time to complete resolution of LRTD symptoms is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.
次要结局
- Time to resolution of LRTD symptoms and 2 systemic symptoms(Day 1 through Day 33)
- Time to resolution of Upper Respiratory Tract Disease congestion), LRTD, and 2 systemic symptoms(Day 1 through Day 33)
- Change from Baseline in severity of RSV LRTD symptoms(Day 1 through Day 33)
- Time to return to usual health(Day 1 through Day 33)
- Time to resolution of all RSV symptoms(Day 1 through Day 33)
- Change from Baseline for impact scale(Day 1 through Day 33)
- Change from Baseline for Health-Related Quality of Life(Day 1 through Day 33)
- Percentage of subjects requiring hospitalization for RSV or other causes;(Day 1 through Day 33)
- All-cause mortality(Day 1 through Day 33)
- Change in infectious RSV viral load over time(Up to Day 14)
- Time to no or mild impact of RSV disease on daily activities, emotions, and social relationships(Day 1 through Day 33)
- Percentage of participants with post-baseline RSV-related complications(Day 1 through Day 33)
- Time to improvement in RSV disease(Day 1 through Day 33)
- Safety as measured by frequency of adverse events (AEs)(Up to Day 33)
- Time to return to usual activities(Day 1 through Day 33)
- Duration of hospitalization for RSV or other causes(Day 1 through Day 33)
- RSV RNA viral load change from Baseline(Days 3, 5, 9, and 14)
- Plasma PK Concentrations of EDP-938(Up to Day 5)
- Time to Resolution of LRTD Symptoms and 2 Systemic Symptoms(Day 1 through Day 33)
- Time to Resolution of All RSV Symptoms(Day 1 through Day 33)
- Time to Complete Resolution of All RSV Symptoms for the mITT Population(Day 1 through Day 33)
- Time to Complete Resolution of All RSV Symptoms for the HR3 Population(Day 1 through Day 33)
- Change From Baseline in Severity of RSV LRTD Symptoms(Day 1 through Day 33)
- Change From Baseline for Impact Scale(Day 1 through Day 33)
- Time to Resolution of Upper Respiratory Tract Disease Congestion, LRTD, and 2 Systemic Symptoms(Day 1 through Day 33)
- Time to no or Mild Impact of RSV Disease on Daily Activities, Emotions, and Social Relationships(Day 1 through Day 33)
- Percentage of Participants With Post-baseline RSV-related Complications(Day 1 through Day 33)
- Time to Improvement in RSV Disease(Day 1 through Day 33)
- Change From Baseline for Health-Related Quality of Life(Day 1 through Day 33)
- Time to Return to Usual Health(Day 1 through Day 33)
- Time to Return to Usual Activities(Day 1 through Day 33)
- Percentage of Subjects Requiring Hospitalization for RSV or Other Causes(Day 1 through Day 33)
- Duration of Hospitalization for RSV or Other Causes(Day 1 through Day 33)
- All-cause Mortality(Day 1 through Day 33)
- RSV RNA Viral Load Change From Baseline for the mITT Population(Days 3, 5, 9, and 14)
- Change in Infectious RSV Viral Load Over Time(Up to Day 14)
- Proportion of Subjects With RSV RNA Viral Load Target Not Detected (TND) for the mITT Population(Days 1, 3, 5, 9 and 14)
- Time to RSV RNA Viral Load TND for the mITT Population(Day 1 through Day 14)
- Safety as Measured by Frequency of Adverse Events (AEs)(Up to Day 33)
- Time to Resolution of RSV Infection Symptoms by Patient Global Impression of Severity (PGI-S) Scale Score for the mITT Population(Day 1 through Day 33)
- Incidence of New Antibiotic Use, or New or Increased Use of Bronchodilators, Systemic or Inhaled Corticosteroids, or Oxygen Supplementation for the mITT Population(Day 1 through Day 33)
- Incidence of Unscheduled Medically Attended Visits for RSV Infection or Other Causes for the mITT Population(Day 1 through Day 33)