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

• ClinicalTrials.gov Identifier: NCT05160636
• Recruitment Status: Recruiting
• First Posted: December 16, 2021
• Last Update Posted: February 28, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

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
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
• Estimated 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: January 31, 2022
• Estimated Primary Completion Date: November 15, 2023
• Estimated Study Completion Date: November 15, 2023

Groups and Cohorts

Group/Cohort	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 [ Time Frame: six months ]
   Utility Index (UI) to measure utility across five timepoints over six months
2. Utility decrements [ Time Frame: six months ]
   utility measured at five timepoints over six months
3. EQ-5D VAS Score [ Time Frame: six months ]
   Health related quality of life over six months
4. WPAI scores [ Time Frame: six months ]
   Work productivity and activity impairment over six months

Secondary Outcome Measures :

1. Proportion of subjects with long-COVID symptoms [ Time Frame: six months ]
   4 weeks after onset of COVID-19 through the 6-month study period
2. Proportion of subjects with emergency room (ER) visit [ Time Frame: six months ]
3. Proportion of subjects with hospital inpatient admission [ Time Frame: six months ]

Biospecimen Retention:   None Retained

Nasopharyngeal swabs that are obtained as SOC for COVID-19 testing.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Participants are 18 years or older who are self-reported symptomatic, who tested positive with RT-PCR at any of the approximately 5,000 CVSH COVID-test sites and consented to participate in the PRO study from mid-October 2021 through mid-January 2022 or when enrollment reaches 600

Criteria

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

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Locations

United States, Rhode Island

CVS Health; Recruiting

Woonsocket, Rhode Island, United States, 02895

Sponsors and Collaborators

Pfizer

Investigators

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

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05160636
• Other Study ID Numbers: C4591034
• First Posted: December 16, 2021
• Last Update Posted: February 28, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

• 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; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases