Patient Reported Health-Related Quality of Life Associated With COVID-19

Study Overview
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Brief Summary
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COVID-19 pandemic elicited broad medical, economic, and social consequences. There is limited research and outstanding data gaps related to understanding the impact of long-term effect of COVID-19 on Health-Related Quality of Life (HRQoL) and Work Productivity and Activity Impairment (WPAI) in the outpatient settings in the US. Information on the evolution of recovery of daily function and the return to the level of health enjoyed by outpatients prior to SARS-CoV-2 infection will inform the overall estimation of the benefits of vaccines (quality-adjusted life years [QALYs] and indirect cost saving) in COVID-19 health economics models.

Detailed Description
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This is a non-interventional (NI) prospective longitudinal participant reported outcome (PRO) study on adults who consented to participate in the PRO study on HRQoL and WPAI. To be eligible for the enrollment, participants would have at least one self-reported ARI symptom and RT-PCR test positive confirmation.

Official Title
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Patient-Reported Health-Related Quality of Life Associated With COVID-19: A Prospective Survey Study on Symptomatic Adults Confirmed With RT-PCR From Outpatient Settings in the US

Conditions
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COVID-19

Intervention / Treatment
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* Other: ARI symptom and Positive RT-PCR for COVID-19


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Self-reported at least one symptom in the CVS Health pre-test screening questionnaire Positive result reported from the laboratory using RT-PCR test method 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 Exclusion Criteria: No symptom reported in the CVSH pre-test questionnaire COVID-19 test is done with non-RT-PCR methods such as a rapid antigen test or antibody test

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study cohort positive for COVID-19<br>Cohort will be those that are COVID-19 positive by RT-PCR from a SOC nasopharyngeal swab. | Other: ARI symptom and Positive RT-PCR for COVID-19<br>* Subjects with a self reported ARI and a positive COVID-19 nasopharyngeal swab collected for SOC will be approached to participate to assess impact on COVID-19 infection on quality of life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health Related Quality of Life (HRQoL) using EQ-5D-5L | To assess the change in HRQoL using EQ-5D-5L before COVID-19 and over a 6-month period following the RT-PCR confirmed COVID-19. | 6 months | 
| Change in Health Related Quality of Life (HRQoL) using WPAI:GH | To assess the change in HRQoL using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) before COVID-19 and over a 6-month period following the RT-PCR confirmed COVID-19. | 6 months | 
| EQ-5D-5L Utility Index (UI) scores | To estimate the EQ-5D-5L UI scores and their change across six time points in a span of six months following the RT-PCR confirmed COVID-19. | 6 months | 
| Visual Analog Scale (VAS) scores | To estimate the VAS scores and their change across six time points in a span of six months following the RT-PCR confirmed COVID-19. | 6 months | 
| WPAI scores | To estimate the WPAI scores and their change across six time points in a span of six months following the RT-PCR confirmed COVID-19. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and duration of SARS-CoV-2 symptoms | To characterize prevalence and duration of SARS-CoV-2 symptoms before COVID-19 and up to 6 months (acute phase and Long COVID). | up to 6 months | 
| Fatigue before COVID-19 | To assess fatigue (using PROMIS questionnaire Fatigue short-form 8a) before COVID-19 and over a six-month follow-up. | 6 months | 
| Fatigue after COVID-19 | To estimate the PROMIS questionnaire Fatigue short-form 8a score and its change across six time points in a span of six months following the RT-PCR confirmed COVID-19. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS CoV-2, acute respiratory infection, positive RT-PCR.