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

• Sponsor: Pfizer (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05160636
• Collaborator: (none)
• Enrollment: 999
• Location: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 125.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID19	Other: ARI symptom and Positive RT-PCR for COVID-19

Detailed Description

This is a non-intervention (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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 999 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jan 31, 2022
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Study cohort positive for COVID 19 Cohort will be those that are COVID19 positive by RTPCR from a SOC nasopharyngeal swab.	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.

Outcome Measures

Primary Outcome Measures

1. Utility Index [six months]

   Utility Index (UI) to measure utility across five timepoints over six months

2. Utility decrements [six months]

   utility measured at five timepoints over six months

3. EQ-5D VAS Score [six months]

   Health related quality of life over six months

4. WPAI scores [six months]

   Work productivity and activity impairment over six months

Secondary Outcome Measures

1. Proportion of subjects with long-COVID symptoms [six months]

   4 weeks after onset of COVID-19 through the 6-month study period

2. Proportion of subjects with emergency room (ER) visit [six months]

3. Proportion of subjects with hospital inpatient admission [six months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CVS Health	Woonsocket	Rhode Island	United States	02895

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05160636
• Other Study ID Numbers: C4591034
• First Posted: Dec 16, 2021
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: COVID-19; SARS CoV-2; acute respiratory infection; positive RT-PCR.
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Mar 2, 2022