Registry to Study Factors That May Impact COVID-19 Occurrence and Severity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35,278
- 试验地点
- 1
- 主要终点
- COVID-19 symptom occurrence and severity
研究概览
简要总结
COVID-19 Active Research Experience (CARE) is an observational, direct-to-participant, web-based, longitudinal study of adults with COVID-19 or COVID-19 like illness or who were vaccinated against COVID-19 to better understand risk factors, symptoms, and treatments for COVID-19 illness and vaccine safety and effectiveness.
详细描述
This is an observational, direct-to-participant, web-based, longitudinal study of adults with COVID-19 or COVID-19 like illness to better understand risk factors, symptoms, and treatments for COVID-19 illness and vaccine safety and effectiveness. Upon consent and enrollment, participants will complete an initial baseline survey reporting their demographics, relevant medical history, testing, vaccination, symptoms, use of prescription medications as well as use of supplements and other factors. The study follow-up period is 12 months. During the first month of follow-up participants will be invited to complete a symptom diary weekly to gauge symptom progression and severity and to provide updates on pharmaceutical and non-pharmaceutical interventions as well as healthcare encounters. Reporting will then reduce to monthly for Month 2 through 12.
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
- •Adult (18 years or older)
- •Currently living in the US or UK
- •Have regular access to a computer, smartphone or tablet and sufficient internet to support registry demands (note: this registry is designed to operate well even in regions with low bandwidth)
- •Willing and able to provide informed consent
- •Willing and able to follow the procedures of the study
- •Participants must also meet at least one of the following conditions:
- •Have COVID-19 or COVID-19 like symptoms
- •Received a COVID-19 vaccine
- •Potential exposure to COVID-19
排除标准
- •Unable to provide informed consent
- •Unable to perform the requested study tasks and unable or unwilling to assign a proxy informant to complete the tasks
结局指标
主要结局
COVID-19 symptom occurrence and severity
时间窗: 12 months
Occurrence and severity of potential COVID-19 symptoms as reported by participants in the survey
Occurrence of medically attended events after vaccination
时间窗: 1 month
Occurrence of medically attended events as reported by participants after after SARS-CoV-2 vaccine
COVID-19 risk factors
时间窗: 12 months
Assess potential role of comorbidities and concomitant medications on COVID-19 occurrence and severity
Occurrence and severity of COVID-19 infection after vaccination
时间窗: 12 months
Occurrence and severity of COVID-19 infection as reported by participants after SARS-CoV-2 vaccine
COVID-19 treatments
时间窗: 12 months
Prescription treatments for COVID-19 as reported by participants in the survey
次要结局
未报告次要终点