Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,000
- 试验地点
- 8
- 主要终点
- Assess for medium and long-term sequalae of SARS-CoV-2 infection
研究概览
简要总结
The Innovative Support for Patients with SARS COV-2 Infections Registry (INSPIRE) study is a CDC-funded COVID-19 project to understand the long-term health outcomes in recently tested adults, both negative and positive, who have suspected COVID symptoms at the time of their test. Participants will complete short online surveys every 3 months for 18 months, share information about their health using a secure web-based platform, and are compensated for their time.
详细描述
This study will use a digital platform to longitudinally track comprehensive information including patient self-report as well as data that describe the process and outcome of care in the electronic medical record (EMR) of a large representative sample of patients under investigation for SARSCOV2. The objective is to generate knowledge rapidly using digital tools and collaborative sciences to produce real-time data, analysis, and reporting compared to more traditional approaches. An additional goal is to promote an open science approach whereby scientists, with proper approvals and in line with the permissions granted by the participants, have the opportunity to work with data in ways that protect individual privacy but promote rapid dissemination and implementation of knowledge.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Assess for medium and long-term sequalae of SARS-CoV-2 infection
时间窗: 18 months post enrollment
Clinical phenotypes of sequelae will be determined at the time of analysis based on published literature
次要结局
- Ambulatory care and/or ED visits post enrollment(18 months post enrollment)
- Hospitalizations post enrollment(18 months post enrollment)
- ICU-free survival(18 months post enrollment)
- Incident myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)(18 months post enrollment)
- Death during hospital admission(18 months post enrollment)
- Hospital-free survival(18 months post enrollment)
研究者
Michael Gottlieb
Associate Professor of Emergency Medicine
Rush University Medical Center