EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois: CONTACT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,007
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Evidence of Prior SARS-CoV-2 Infection
研究概览
简要总结
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to assess infection of SARS-CoV-2 and how quality of life is affected in adult volunteers in Lake County, Illinois.
Volunteers will be recruited through digital advertisements and participants will be required to fill an online questionnaire. Upon consent, participants will be required to provide nasal swab and blood sample. Approximately 1250 adult volunteers living or working in Lake County, IL will be enrolled.
Participants will be followed for approximately 9 months and will be required to provide nasal swab and blood samples every 3 months and complete questionnaires every 2 weeks.
There may be higher treatment burden for participants in this trial. Participants will be monitored by medical assessments, blood tests and questionnaires.
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
- •Currently living or employed in Lake County, Illinois.
- •Have regular access to computer, smartphone or tablet and sufficient internet access to connect to study platform.
- •Willing and able to provide informed consent for collection of online data and of respiratory and blood specimens.
- •Willing and able to follow the procedures of the study.
- •Able to complete survey in English or Spanish.
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.
- •Hospitalized at the time of study enrollment.
结局指标
主要结局
Percentage of Participants With Evidence of Prior SARS-CoV-2 Infection
时间窗: Baseline (Week 0)
SARS-CoV-2 infection prior to enrollment is assessed by Immunoglobulin G (IgG) serology testing and/or self-reported diagnosis.
Percentage of Participants With Incidence of SARS-CoV-2 Infection
时间窗: Up to Approximately 9 months
Incidence of SARS-CoV-2 Infection is assessed by positive PCR test, positive IgG serology test or COVID-19 diagnosis.
Percentage of Participants With Current SARS-CoV-2 Infection
时间窗: Baseline (Week 0)
SARS-CoV-2 active infection is assessed by polymerase chain reaction (PCR) testing.
次要结局
- Percentage of Participants With COVID-19 Hospitalization(Up to approximately 9 months)
- Percentage of Participants With Influenza and COVID-like Illness(Up to approximately 9 months)
- Change in Quality of Life (QOL)(Up to approximately 9.5 months)
- Time to Symptom Resolution(Up to approximately 9 months)
- Time to Infection(Up to approximately 9 months)
- Time to Symptom Onset(Up to approximately 9 months)