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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05160636
Recruitment Status : Recruiting
First Posted : December 16, 2021
Last Update Posted : February 28, 2023
Information provided by (Responsible Party):

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

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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

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.

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.

Information from the National Library of Medicine

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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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05160636

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

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United States, Rhode Island
CVS Health Recruiting
Woonsocket, Rhode Island, United States, 02895
Sponsors and Collaborators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05160636    
Other Study ID Numbers: C4591034
First Posted: December 16, 2021    Key Record Dates
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
acute respiratory infection
positive RT-PCR.
Additional relevant MeSH terms:
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Pneumonia, Viral
Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases