Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Mild COVID-19 Patients in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 1,085
- 试验地点
- 14
- 主要终点
- One-year utility score of health related quality of life
研究概览
简要总结
The present prospective cohort study aims to assess factors associated with of one-year health-related quality of life and physical, cognitive and mental health outcomes among adult patients with mild COVID-19. Adult patients with symptomatic COVID-19 not requiring hospitalization will be followed through structured and centralized telephone interviews performed at 1, 3, 6, 9 and 12 months after enrollment.
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
- •Age ≥18 years;
- •Positive polymerase chain reaction (PCR) test for SARS-CoV-2;
- •At least one of the following symptoms: fever, cough, sneezing, dyspnea, fatigue, smell alteration, rhinorrhea, sore throat, myalgia, arthralgia, diarrhea;
- •Outpatient COVID-19 care at the moment of enrollment (without indication for in-hospital care).
排除标准
- •Severe comorbidity with life expectancy less than 3 months;
- •Absence of proxy for patients with communication difficulties;
- •Absence of telephone contact;
- •Refusal or withdrawal of agreement to participate;
- •Previous enrollment in the study.
结局指标
主要结局
One-year utility score of health related quality of life
时间窗: The outcome will be assessed 12 months after enrollment.
The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
次要结局
- Utility score of health related quality of life at 3, 6, and 9 months(The outcome will be assessed at 3, 6, and 9 months after enrollment.)
- Incidence of all-cause mortality(The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.)
- Prevalence of anxiety and depression symptoms(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Incidence of hospitalizations(The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.)
- Prevalence of posttraumatic stress disorder symptoms(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Incidence of major cardiovascular events(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Incidence of new symptomatic COVID-19 infection(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Incidence of return to work or study(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Prevalence of prolonged COVID-19 symptoms(The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.)
- Prevalence of cognitive dysfunction(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Physical functional status(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Instrumental Activities of Daily Living(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
