Selective Trial Of Paxlovid for PASC (STOP-PASC): Randomized Double-Blind Placebo-Controlled Pilot Trial of Paxlovid for the Treatment of PASC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
研究概览
简要总结
The purpose of this study is to compare whether being treated with Paxlovid (nirmatrelvir plus ritonavir) for 15 days works better than being treated with placebo (plus ritonavir) to reduce severe symptoms of Long Covid (the placebo does not have any active drug).
Participants will have 5 planned visits to the study clinic over 15 weeks and will take the drug (or placebo) for the first 15 days.
This study uses the term post-acute sequelae of SARS-CoV-2 (PASC), which is another name for "Long Covid."
详细描述
An exploratory sub-study will investigate the correlation of physical activity and biometric parameters from digital wearable devices with the subjective symptom severity and other patient-reported outcomes in the main study. All participants with iPhone 6S Plus or newer will be offered an opportunity to opt-in to this sub-study. An Apple Watch and Bluetooth-enabled blood pressure monitor will be provided to participants and data will be collected for the duration of the main study to track participants' physiological and behavioral trends in the Paxlovid versus placebo groups.
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
- •Normal or near-normal kidney function
- •History of confirmed COVID-19 infection that preceded the post-COVID symptoms
- •Post-COVID-19 symptoms persisting greater than three months
- •At least 2 post-COVID symptoms of moderate or severe intensity (fatigue, brain fog, shortness of breath, body aches, gastrointestinal symptoms, or cardiovascular symptoms)
- •Willing to report all vaccinations
- •Women of childbearing potential or men whose partners may become pregnant must use acceptable method of contraception during the treatment period and for 28 days after the last dose of the study drug
- •Willing and able to adhere to study procedures and available for the duration of the study
排除标准
- •Suspected or confirmed pregnancy or breastfeeding
- •Severe liver disease
- •Prior use of study drug or other COVID treatment within 30 days
- •Hypersensitivity or other contraindication to any components of the study drug
- •Current or expected use of any medication dependent on or inducer of CYP3A4
- •Current or expected use of supplements or herbs (unless medically necessary) that cannot be temporarily held (period as determined necessary by investigators)
- •HIV infection with viral load >50 copies/ml
- •Suspected or confirmed active COVID infection within 30 days
- •History of COVID vaccine within 28 days prior to enrollment, or other vaccine (influenza, shingles, etc.) within 14 days of enrollment, or planned use of any vaccine until the primary endpoint has been met (10 weeks)
- •Other medical condition(s) or concomitant therapy that would compromise participant's safety or compliance with the study protocol or significantly confound interpretation of study results, as determined by study investigators
- •Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device
- •Inability to provide informed consent
- •Currently hospitalized
研究组 & 干预措施
Nirmatrelvir plus ritonavir
Participants receive nirmatrelvir plus ritonavir (Paxlovid) for 15 days, and attend follow-up visits through week 15.
干预措施: Nirmatrelvir (Drug)
Nirmatrelvir plus ritonavir
Participants receive nirmatrelvir plus ritonavir (Paxlovid) for 15 days, and attend follow-up visits through week 15.
干预措施: Ritonavir (Drug)
Placebo plus ritonavir
Participants receive placebo to match nirmatrelvir plus ritonavir for 15 days, and attend follow-up visits through week 15.
干预措施: Placebo (Drug)
Placebo plus ritonavir
Participants receive placebo to match nirmatrelvir plus ritonavir for 15 days, and attend follow-up visits through week 15.
干预措施: Ritonavir (Drug)
结局指标
主要结局
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
时间窗: Week 10
This measure was to evaluate whether there is a difference between treatment with Paxlovid versus placebo on any of the 6 core symptoms of PASC at week 10 (adjusting for patients' baseline levels). Each symptom (fatigue, brain fog, dyspnea, body aches, gastrointestinal symptoms, cardiovascular symptoms) was assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).
次要结局
- Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score(Day 15)
- Number of Participants Reporting Relief of at Least One Core Symptom for 2 Weeks(Baseline through week 10, assessed at week 10)
- Number of Participants With Overall Alleviation for 2 Weeks(Baseline through week 10, assessed at week 10)
- Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom(Assessed at weeks 5, 10, and 15)
- Time to Relief of the 6 Core Symptoms(Up to 15 weeks)
- Time to Relief of the Most Bothersome Symptom(Up to 15 weeks)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function T-Score(Baseline and week 10)
- Change in PROMIS Fatigue T-Score(Baseline and week 10)
- Change in PROMIS Dyspnea-Severity T-Score(Baseline and week 10)
- Change in PROMIS Cognitive Function Abilities T-Score(Baseline and week 10)
- Change in Orthostatic Vitals Test(Baseline and week 10)
- Change in Heart Rate(Baseline and week 10)
- Change in 1-minute Sit-to-stand Test(Baseline and week 10)
- Patient Global Impression of Severity (PGIS) Scale Score(Day 15, and weeks 5, 10, and 15)
- Patient Global Impression of Change (PGIC) Scale Score(Day 15, and weeks 5, 10, and 15)
- Summative Severity Score for All Core Symptoms(Weeks 5, 10, and 15)
- Percentage of Weeks 1-15 With Mild or no Symptoms(15 weeks)