Placebo-Controlled, Randomized Trial of Ensitrelvir (S-217622) for Viral Persistence and Inflammation in People Experiencing Long COVID (PREVAIL-LC)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score from Baseline.
研究概览
简要总结
Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID. This mechanism may be susceptible to antiviral therapy that blocks viral replication, which has the potential to alleviate long COVID symptoms. This trial will study the safety and efficacy of Ensitrelvir (S-217622), an antiviral, to treat individuals with Long COVID in an adult population.
详细描述
The study will enroll approximately 40 participants who meet the World Health Organization (WHO) Long COVID criteria. Participants will be enrolled at a single center and randomized 1:1 to receive ensitrelvir fumaric acid (Ensitrelvir: S-217622), given orally for 5 days, or placebo. Subjects randomized to receive Ensitrelvir will take 375 mg on day 1, followed by 125 mg daily for 4 additional days. Evaluations will take place at baseline and at timepoints up to 60 days post-initiation of study drug.
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
Double blinded
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ensitrelvir (S-217622)
Ensitrelvir fumaric acid (S-217622) given orally 375 mg on day 1 followed by 125 mg daily for 4 additional days
干预措施: Ensitrelvir (Drug)
Placebo
Placebo administered orally for 5 days
干预措施: Placebo (Other)
结局指标
主要结局
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score from Baseline.
时间窗: Baseline and Day 10
This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on the PROMIS-29 scale between baseline and day 10. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). The primary outcome evaluated will be change in the Physical Health Summary Score.
次要结局
- Change in Quality of Life Score (5-Item EuroQol EQ-5D-5L) Index Value Score from Baseline.(Baseline and Day 10)
- Change in 6 Minute Walking Test (6MWT) from Baseline(Baseline and Day 10)
- Change in Everyday Cognition Form instrument from Baseline(Baseline and Day 10)
- Change in Neurocognition Index (NCI) score from the CNS-VS from Baseline(Baseline and Day 10)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score from Baseline.(Baseline and Day 30)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score from Baseline.(Baseline and Day 30)
- Change in Quality of Life (Global Health Score) on a 100-point Visual-Analogue Scale from Baseline(Baseline and Day 10)
- Change in Duke Activity Status Index (DASI) from Baseline(Baseline and Day 10)
- Change in Orthostatic Intolerance Score from Baseline(Baseline and Day 10)
- Change in World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0) questionnaire from Baseline(Baseline and Day 10)
- Patient Global Impression of Change (PGIC) at D10(Day 10)
- Change in Active Stand Test from Baseline(Baseline and Day 10)
研究者
Timothy Henrich
Professor of Medicine
University of California, San Francisco