Patient-Reported Outcomes Associated With COVID-19 and Influenza: A Prospective Survey Study on Outpatient Symptomatic Adults With Laboratory-Confirmed Illness in the United States
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Change in Health Related Quality of Life (HRQoL) using EQ-5D-5L
研究概览
简要总结
The main purpose of this study is to understand:
- the symptoms of COVID-19 or influenza
- health-related outcomes of people with COVID-19 or influenza
- the effects of vaccines in people with COVID-19 or influenza.
This study will take in participants who are:
- 18 years or older
- reported to have symptoms with lab tests that have confirmed illness. The lab tests can be tested at any of Walgreens pharmacy COVID-19 or influenza test sites.
The study will collect vaccine history information from participants who are ready to take part in the study. Participant will be emailed a form with questions about their health related to COVID-19 or influenza during twelve follow-ups over a 6-month period.
详细描述
This is a prospective non-interventional longitudinal cohort survey study. Repeated measures on PROs: symptoms (prevalence, frequency, duration, and severity), EQ-5D-5L, WPAI and PROMIS-Fatigue short form 8a over 6 months will be collected and evaluated.
COVID-19 Cohort: Participants 18 years or older with laboratory-confirmed COVID-19 illness and at least one patient-reported symptom.
Influenza Cohort: Participants 18 years or older with laboratory-confirmed influenza illness and at least one patient-reported symptom.
All study objectives and outcomes will be assessed separately for the two study cohorts.
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 or older
- •Self-reported at least one symptom in the screening questionnaire
- •Positive result reported from the laboratory
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
- •Able to complete the questionnaires by themselves in English
排除标准
- •Positive result for both COVID-19 and influenza (coinfection)
- •COVID-19 test is done with non-RT-PCR methods such as a rapid antigen test or antibody test
结局指标
主要结局
Change in Health Related Quality of Life (HRQoL) using EQ-5D-5L
时间窗: 6 Months
To assess the change in HRQoL using EQ-5D-5L before COVID-19 or influenza and over a 6-month period following lab confirmed COVID-19 or influenza.
Prevalence, Severity, and duration of influenza symptoms
时间窗: 6 Months
To characterize prevalence and duration of influenza symptoms before influenza and up to 6 months (acute phase and Long Flu).
Prevalence, Severity, and duration of SARS-CoV-2 symptoms
时间窗: 6 Months
To characterize prevalence and duration of SARS-CoV-2 symptoms before COVID-19 and up to 6 months (acute phase and Long COVID).
Visual Analog Scale (VAS) scores
时间窗: 6 Months
To estimate the VAS scores and their change over six months following the lab confirmed COVID-19 or influenza.
Change in Health Related Quality of Life (HRQoL) using WPAI:GH
时间窗: 6 Months
To assess the change in HRQoL using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) before COVID-19 or influenza and over a 6-month period following lab confirmed COVID-19 or influenza.
EQ-5D-5L Utility Index (UI) scores
时间窗: 6 Months
To estimate the EQ-5D-5L UI scores and their change over six months following lab confirmed COVID-19 or influenza.
Work Productivity and Activity Impairment (WPAI) scores
时间窗: 6 Months
To estimate the WPAI scores and their change over six months following the lab confirmed COVID-19 or influenza.
次要结局
- Fatigue after COVID-19 or influenza(6 Months)