An International Observational Study of Outpatients With SARS-CoV-2 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11,973
- 试验地点
- 4
- 主要终点
- Time to Expiration
研究概览
简要总结
The general aim of this study is to estimate the rate of disease progression for adults testing positive for SARS-CoV-2. The primary endpoint for this study and the basis for sample size is hospitalization or death during the 28 day follow-up period. In some locations special facilities are being built/utilized for quarantine/public health reasons for those who are SARS-CoV-2 positive. Hospitalization is defined as a stay for at least 18 hours, irrespective of reason, at a hospital or one of these special facilities after study enrollment.
Secondary outcomes include participant-reported health status and change in severity of dyspnoea.
详细描述
SARS-CoV-2 is a coronavirus that emerged in China in late 2019 causing a novel Corona-Virus Induced Disease (COVID-19). COVID-19 is spreading rapidly throughout the world. While a proportion of people with COVID-19 have sufficiently severe symptoms to require hospitalization at the time of initial symptom onset, in others the disease may remain mild, and in some cases there has been observed a worsening of symptoms a few days after initial presentation with relatively mild symptoms. There is an urgent need for understanding the progression of disease for individuals with SARS-CoV-2 infection/COVID-19 who do not require immediate hospitalization.
This is an international, observational cohort study of adults with SARS-CoV-2 infection/COVID-19 managed as outpatients (not hospitalized). This study will also be a platform for the enrollment of outpatients for randomized trials that will be conducted by the INSIGHT group.
Those with confirmed SARS-CoV-2 infection will form an observational cohort study and be followed for 28 days. Procedures and data collection have been streamlined to facilitate the enrollment of a large number of adults at INSIGHT sites around the world.
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
- 否
入选标准
- •Not currently hospitalized
排除标准
- •Persons with a known positive SARS-CoV-2 test > 28 days ago
结局指标
主要结局
Time to Expiration
时间窗: 28 days
Outcome reported as the mean number of days from enrollment to expiration (death) due to COVID-19.
Time to Hospitalization
时间窗: 28 days
Outcome reported as the mean number of days from enrollment to hospitalization due to COVID-19.
次要结局
- Rate of Hospitalization at 28 Days(28 days)
- Participant Health at 7 Days(7 days)
- Rate of Hospitalization at 7 Days(7 days)
- Rate of Hospitalization at 14 Days(14 days)
- Participant Health at 14 Days(14 days)
- Modified Borg Dyspnea Scale at 7 Days(7 Days)
- Modified Borg Dyspnea Scale at 14 Days(14 Days)
- Modified Borg Dyspnea Scale at 28 Days(28 Days)
- Rate of Death at 7 Days(7 days)
- Rate of Death at 14 Days(14 days)
- Rate of Death at 28 Days(28 days)
- Participant Health at 28 Days(28 days)