Incidence, Associated Factors, and Burden of Post COVID-19 Condition in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,694
- 试验地点
- 1
- 主要终点
- Post COVID-19 condition according to the WHO definition
研究概览
简要总结
This is a national retrospective cohort study with internet-based recruitment which intends to enroll 1,694 adult patients with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil. Participants with confirmed symptomatic COVID-19 after january 2022 will be evaluated in order to assess incidence, potential risk factors and impact of post COVID-19 condition according to the WHO definition on health-related quality of life and other relevant patient-centered outcomes.
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
- 是
入选标准
- •Age ≥ 18 years;
- •Brazilian resident;
- •Symptomatica COVID-19 confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or antigen test for SARS-COV-2 after January 2022, with diagnosis at least 90 days before recruitment.
排除标准
- •No availability to participate in remote research appointments;
- •Communication difficulty (aphasia, important hearing loss, non-portuguese speaker, severe dementia)
- •Refuse to provide informed consent
结局指标
主要结局
Post COVID-19 condition according to the WHO definition
时间窗: 3 to 24 months
Post COVID-19 condition occurs in individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms and that last for at least 2 months and cannot be explained by an alternative diagnosis
EQ5D-3L
时间窗: 3 to 24 months
Health-related quality of life assessed using the EuroQol five-dimensional 3-level descriptive system (EQ5D-3L). This outcome will be considered as primary when Post COVID-19 condition be used as exposure.
次要结局
- Depression symptoms(3 to 24 months)
- Functional status(3 to 24 months)
- Cognition(3 to 24 months)
- Time to return to work or studies(3 to 24 months)
- Costs(3 to 24 months)
- Instrumental activities of daily living(3 to 24 months)
- Posttraumatic stress symptoms(3 to 24 months)
- Anxiety symptoms(3 to 24 months)
- Healthcare utilization(3 to 24 months)