Patient-Reported Outcomes Associated With COVID-19 and Influenza: A Prospective Survey Study on Outpatient Symptomatic Adults With Test-Confirmed Illness in the United States
概览
- 阶段
- 不适用
- 干预措施
- COVID-19 Vaccine
- 疾病 / 适应症
- COVID-19
- 发起方
- Pfizer
- 入组人数
- 999
- 试验地点
- 1
- 主要终点
- Change in Health Related Quality of Life (HRQoL) using EQ-5D-5L
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
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 (influenza only included in updated study analyses)
- the potential effects of COVID-19 vaccines in people with COVID-19
This study will enroll participants who are:
- 18 years or older
- reported to have symptoms with tests that have confirmed illness. The tests can be taken at any of CVS 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 multiple 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 including: symptoms (prevalence, frequency, duration, and severity), EQ-5D-5L, and WPAI over 6 months will be collected and evaluated. COVID-19 Cohort: Participants 18 years or older with test-confirmed COVID-19 illness and at least one patient-reported symptom. Influenza Cohort: Participants 18 years or older with test-confirmed influenza illness and at least one patient-reported symptom. All study objectives and outcomes will be assessed separately for the two study cohorts. Influenza cohort is only included in updated study analyses.
研究者
入排标准
入选标准
- •Age 18 or older
- •Self-reported at least one symptom in the CVS Health pre-test screening questionnaire
- •Positive result reported from diagnostic test for COVID-19 (or influenza in updated analysis)
- •Evidence of a signed and dated informed consent through electronic consent process indicating that the participant has been informed of all pertinent aspects of the study
- •Able to complete the questionnaires by themselves in English or Spanish
排除标准
- •\- No symptoms reported in the study screening questionnaire
研究组 & 干预措施
COVID-19 Positive
Test-confirmed COVID-19 illness and at least one patient-reported symptom
干预措施: COVID-19 Vaccine
Influenza Positive
Test-confirmed influenza illness and at least one patient-reported symptom
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 the test-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 across six time points in a span of six months following the test-confirmed COVID-19 or influenza.
Visual Analog Scale (VAS) scores
时间窗: 6 months
To estimate the VAS scores and their change across six time points in a span of six months following the test-confirmed COVID-19 or influenza.
WPAI scores
时间窗: 6 months
To estimate the WPAI scores and their change across six time points in a span of six months following the test-confirmed COVID-19 or influenza.
次要结局
- Prevalence and duration of SARS-CoV-2 symptoms(6 months)
- Prevalence, Severity, and duration of influenza symptoms aggregated as index score area under the curve(6 Months)
- Fatigue before COVID-19(6 months)
- Fatigue after COVID-19(6 months)