A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Viral shedding time
研究概览
简要总结
The study was designed to analyze the efficacy and safety of Paxlovid for the treatment of COVID-19.
详细描述
The study is a real-world study and the case records of patients with COVID-19 who visit Huashan Hospital affiliated to Fudan University from 2022 to 2027 and receive Paxlovid therapy will be collected in this study. The medical data including patient demographic, clinical characteristics, laboratory examination, history of treatments, adverse reactions and treatment outcome will be extracted to analyze the effectivity and safety of paxlovid and explore the prognosis-relevant factors of COVID-19.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have a positive SARS-CoV-2 test result;
- •Participants who have one or more mild or moderate COVID-19 symptoms.
排除标准
- •No specific exclusion criteria in this real world study.
研究组 & 干预措施
Paxlovid
Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive Paxlovid therapy
干预措施: Paxlovid (Drug)
结局指标
主要结局
Viral shedding time
时间窗: up to 28 days
time from the first positive testing to the first day of nucleic acid Ct value\> 35 for both ORF1ab and N gene (in two consecutive).
Percentage of the participants who have progression of COVID-19
时间窗: up to 28 days
Percentage of participants who experience these events by Day 28 Progress to severe and/or critical COVID-19; Death from any cause
次要结局
- AEs and SAEs through Day 28(up to 28 days)
- Percentage of participants who turned negative for SARS-CoV-2(up to 28 days)
- Time to sustained clinical recovery(up to 28 days)