NCT05160636

Brief Summary

The main purpose of this study is to understand:

  • the symptoms of COVID-19 or influenza- health-related outcomes of people with COVID-19 or influenza (influenza only included in updated study analyses)
  • the potential effects of COVID-19 vaccines in people with COVID-19 This study will enroll participants who are:
  • 18 years or older
  • reported to have symptoms with tests that have confirmed illness. The tests can be taken at any of CVS pharmacy COVID-19 or influenza test sites. The study will collect vaccine history information from participants who are ready to take part in the study. Participant will be emailed a form with questions about their health related to COVID-19 or influenza during multiple follow-ups over a 6-month period.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
999

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2022Jan 2027

First Submitted

Initial submission to the registry

December 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

March 31, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

December 15, 2021

Last Update Submit

March 30, 2026

Conditions

COVID-19Coronavirus Disease 2019Influenza

Keywords

Patient-Reported OutcomesHumanistic BurdenQuality of LifeDisease Symptoms AssessmentCOVID-19SARS-CoV-2Severe Acute Respiratory Syndrome Coronavirus 2 InfectionAcute respiratory infectionInfluenzaHuman Influenza

Outcome Measures

Primary Outcomes (4)

  • 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 or influenza and over a 6-month period following the test-confirmed COVID-19 or influenza.

    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 test-confirmed COVID-19 or influenza.

    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 test-confirmed COVID-19 or influenza.

    6 months

  • WPAI scores

    To estimate the WPAI scores and their change across six time points in a span of six months following the test-confirmed COVID-19 or influenza.

    6 months

Secondary Outcomes (4)

  • Prevalence and duration of SARS-CoV-2 symptoms

    6 months

  • Prevalence, Severity, and duration of influenza symptoms aggregated as index score area under the curve

    6 Months

  • Fatigue before COVID-19

    6 months

  • Fatigue after COVID-19

    6 months

Study Arms (2)

COVID-19 Positive

Test-confirmed COVID-19 illness and at least one patient-reported symptom

Biological: COVID-19 Vaccine

Influenza Positive

Test-confirmed influenza illness and at least one patient-reported symptom

Interventions

COVID-19 VaccineBIOLOGICAL

Receipt of Pfizer BioNTech COVID-19 vaccine

COVID-19 Positive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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. Updated study analysis included participants 18 years or older who are self-reported symptomatic, with test-confirmed illness when tested at any of CVS pharmacy COVID-19 or influenza test sites, and consent to participate in the study.

You may qualify if:

  • Age 18 or older
  • Self-reported at least one symptom in the CVS Health pre-test screening questionnaire
  • Positive result reported from diagnostic test for COVID-19 (or influenza in updated analysis)
  • 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

You may not qualify if:

  • \- No symptoms reported in the study screening questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer

New York, New York, 10001, United States

Location

Related Publications (3)

  • Sun X, Di Fusco M, Lupton LL, Yehoshua A, Alvarez MB, Allen KE, Puzniak L, Lopez SMC, Cappelleri JC. Predictors of Long COVID Among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy. Healthcare (Basel). 2024 Nov 21;12(23):2321. doi: 10.3390/healthcare12232321.

    PMID: 39684943DERIVED

  • Di Fusco M, Cappelleri JC, Yehoshua A, Craig KJT, Alvarez MB, Allen KE, Porter TM, Lopez SMC, Puzniak L, Sun X. Associations between symptom-based long COVID clusters and long-term quality of life, work and daily activities among individuals testing positive for SARS-CoV-2 at a national retail pharmacy. J Patient Rep Outcomes. 2024 Oct 22;8(1):122. doi: 10.1186/s41687-024-00797-7.

    PMID: 39436613DERIVED

  • Sun X, Di Fusco M, Puzniak L, Coetzer H, Zamparo JM, Tabak YP, Cappelleri JC. Assessment of retrospective collection of EQ-5D-5L in a US COVID-19 population. Health Qual Life Outcomes. 2023 Sep 8;21(1):103. doi: 10.1186/s12955-023-02187-x.

    PMID: 37679771DERIVED

Related Links

Biospecimen

Retention: NONE RETAINED

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

MeSH Terms

Conditions

COVID-19Influenza, Human

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOrthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2021

First Posted

December 16, 2021

Study Start

January 31, 2022

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

March 31, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)