A Retrospective, Real World Study to Analyze Disease Outcomes in Patients With Mild to Moderate Coronavirus Disease 2019 (COVID-19)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Percentage of participants who experience these events
研究概览
简要总结
The purpose of this retrospective study is to analyze real-world disease progression in mild-moderate COVID-19 patients with at least one risk factor for serve COVID-19 illness or death.
详细描述
This study is a retrospective, real world study, without any intervention in clinical diagnosis and treatment, and only real world data are collected for analysis.
The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
The study will collect and analyze available symptoms, risk factors and SARS-COV-2 Ct value up to 28 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Participants who have a positive SARS-CoV-2 test result.
- •Participants who have one or more mild or moderate COVID-19 symptoms.
- •Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to Day 1; ≤5 days from the first onset of COVID-19 symptoms to Day
- •Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death.
排除标准
- •Participants who are diagnosed with severe/critical COVID-19 before Day
- •Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute before Day
- •Participants who have received mechanical ventilation before Day
- •Participants who have received or plan to receive a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) before and during hospitalization.
- •Participants who have received convalescent COVID-19 plasma treatment before and during hospitalization.
结局指标
主要结局
Percentage of participants who experience these events
时间窗: Day 1 to 28 days
Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause
Percentage of the participants who have progression of COVID-19
时间窗: Day 1 to 28 days
Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause
次要结局
- Time to sustained negative conversion of SARS-CoV-2(Up to 28 days)
- Percentage of participants who turned negative for SARS-CoV-2(Day 3, 5, 7, 10, 14)
- Time to sustained clinical recovery(Up to 28 days)
- Time to sustained disappearance of clinical symptoms(Up to 28 days)
- Time to initial negative conversion of SARS-COV-2(Up to 28 days)
- The change of SARS-COV-2 Ct value(Day 3, 5, 7, 10, 14)
- Safety assessment Results: such as AEs and SAEs through Day 28(Up to 28 days)