Scripps-eMed Covid-19 Study: A Prospective Monitoring Study for Those Individuals Treated With Paxlovid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 917
- 试验地点
- 2
- 主要终点
- Paxlovid Rebound
研究概览
简要总结
A prospective monitoring study for those individuals treated with Paxlovid
详细描述
The purpose of this study is to understand the epidemiology and pathophysiology of Paxlovid rebound in patients with acute Covid-19 infection who have been prescribed the Paxlovid per standard of care.
The study will be a collaborative effort between Scripps and eMed, digitally recruiting 800 participants who have tested positive for Covid-19 and have agreed to be prescribed Paxlovid on the eMed platform.
The vision of the study is to understand Paxlovid rebound and ultimately inform management of acute Covid-19 infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18
- •Covid positive
- •Qualified for Paxlovid prescription (treatment decision already made prior to enrollment)
排除标准
- •Non-english speaking
- •Resides outside of the United States
研究组 & 干预措施
Paxlovid Cohort
Participants will be separated into 2 arms that are self-selected through the decision to opt in or out of Paxlovid. After patients are offered a 5-day course of Paxlovid and have made a treatment decision they will be eligible to join the study. Arm 1 will include 400 participants that opt to take the 5-day course of Paxlovid. Participation will look identical in this study.
Control Cohort
Participants will be separated into 2 arms that are self-selected through the decision to opt in or out of Paxlovid. After patients are offered a 5-day course of Paxlovid and have made a treatment decision they will be eligible to join the study. Arm 2, control, will include 400 participants that opt out of taking the 5-day course of Paxlovid. Participation will look identical in this study.
结局指标
主要结局
Paxlovid Rebound
时间窗: 16 day period
Incidence of paxlovid rebound defined as test positivity after a documented negative rapid antigen test post 5 day course of Paxlovid
次要结局
未报告次要终点
研究者
Jay Pandit
Study Principal Investigator
Scripps Translational Science Institute