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临床试验/NCT05197647
NCT05197647进行中(未招募)不适用

Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Mild COVID-19 Patients in Brazil

Hospital Moinhos de Vento14 个研究点 分布在 1 个国家目标入组 1,085 人开始时间: 2022年1月25日最近更新:
适应症

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

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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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