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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05160636
• Other study ID #: C4591034
• Status: Recruiting
• Start date: January 31, 2022
• Est. completion date: March 15, 2026

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 999
• Est. completion date: March 15, 2026
• Est. primary completion date: March 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• ARI symptom and Positive RT-PCR for COVID-19
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.

Locations

Country	Name	City	State
United States	CVS Health	Woonsocket	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	CVS Caremark

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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

External Links

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