A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza

Conditions

Coronavirus Disease 2019, COVID-19, Influenza

Keywords

Patient-Reported Outcomes, Humanistic Burden, Quality of Life, Disease Symptoms Assessment, COVID-19, SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus 2 Infection, Acute respiratory infection, Influenza, Human Influenza

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.

Detailed description

This is a prospective non-interventional longitudinal cohort survey study. Repeated measures on PROs including: symptoms (prevalence, frequency, duration, and severity), EQ-5D-5L, and WPAI over 6 months will be collected and evaluated. COVID-19 Cohort: Participants 18 years or older with test-confirmed COVID-19 illness and at least one patient-reported symptom. Influenza Cohort: Participants 18 years or older with test-confirmed influenza illness and at least one patient-reported symptom. All study objectives and outcomes will be assessed separately for the two study cohorts. Influenza cohort is only included in updated study analyses.

Tianyan Hu, Laura L. Lupton, Alon Yehoshua, Joseph C. Cappelleri, Meghan Gavaghan et al. (10 authors)

BMC Infectious Diseases2026-07-09

10.1186/s12879-026-13950-y

P-697. Symptom Burden During the First Week of Acute Influenza Infection Among US Adults: An Interim Analysis of a Nationwide Prospective Study during the 2024/25 Season

Tianyan Hu, Laura L Lupton, Alon Yehoshua, Joseph C Cappelleri, Meghan Gavaghan et al. (9 authors)

Open Forum Infectious Diseases2026-01-01

10.1093/ofid/ofaf695.910

P-2201. The Burden of Influenza on Health-Related Quality of Life and Work Productivity During the First Week of Infection Among US Adults: An Interim Analysis of a Nationwide Prospective Study

Tianyan Hu, Alon Yehoshua, Joseph C Cappelleri, Meghan Gavaghan, Manuela Di Fusco et al. (6 authors)

Open Forum Infectious Diseases2026-01-01

10.1093/ofid/ofaf695.2364

P-1977. Six-Month Trajectory of Symptoms of COVID-19 Fatigue by Age and BNT162b2 COVID-19 Vaccination Status: A Prospective Study among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy

Manuela Di Fusco, Alexandra Berk, Kristen E. Allen, Thomas M. Porter, Mary B. Alvarez et al. (8 authors)

Open Forum Infectious Diseases2025-01-29

10.1093/ofid/ofae631.2135

P-2060. Effectiveness of BNT162b2 COVID-19 Vaccination Against Long COVID Among Older Adults: A Nationwide Study

Manuela Di Fusco, Abby E. Rudolph, Laura Lupton, Joseph C. Cappelleri, Alon Yehoshua et al. (8 authors)

Open Forum Infectious Diseases2025-01-29

10.1093/ofid/ofae631.2216

Predictors of Long COVID Among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy

Xiaowu Sun, Manuela Di Fusco, Laura Lupton, Alon Yehoshua, Mary B. Alvarez et al. (9 authors)

Healthcare2024-11-21

10.3390/healthcare12232321

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.

Di Fusco M, Cappelleri JC, Yehoshua A, Craig KJT, Alvarez MB, Allen KE, Porter TM, Lopez SMC, Puzniak L, Sun X.

2024-10-221 citations

10.1186/s41687-024-00797-7

Impact of Bivalent BA.4/5 BNT162b2 COVID-19 Vaccine on Acute Symptoms, Quality of Life, Work Productivity and Activity Levels among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy

Manuela Di Fusco, Xiaowu Sun, Laura Anatale‐Tardiff, Alon Yehoshua, Henriette Coetzer et al. (11 authors)

Vaccines2023-10-317 citations

10.3390/vaccines11111669

Assessment of retrospective collection of EQ-5D-5L in a US COVID-19 population

Xiaowu Sun, Manuela Di Fusco, Laura Puzniak, Henriette Coetzer, Joann M. Zamparo et al. (7 authors)

Health and Quality of Life Outcomes2023-09-0714 citations

10.1186/s12955-023-02187-x

Interventions

BIOLOGICALCOVID-19 Vaccine

Receipt of Pfizer BioNTech COVID-19 vaccine

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 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

Exclusion criteria

\- No symptoms reported in the study screening questionnaire

Design outcomes

Primary

Measure	Time frame	Description
Change in Health Related Quality of Life (HRQoL) using EQ-5D-5L	6 months	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.
EQ-5D-5L Utility Index (UI) scores	6 months	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.
Visual Analog Scale (VAS) scores	6 months	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.
WPAI scores	6 months	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.

Secondary

Measure	Time frame	Description
Prevalence and duration of SARS-CoV-2 symptoms	6 months	To characterize prevalence and duration of SARS-CoV-2 symptoms before COVID-19 and up to 6 months (acute phase and Long COVID).
Prevalence, Severity, and duration of influenza symptoms aggregated as index score area under the curve	6 Months	To characterize prevalence and duration of influenza symptoms before influenza and up to 6 months (acute phase and Long Flu). Outcome will be aggregated by assigning a point-scale to the symptom severity and calculating the area under the curve of the severity index score.
Fatigue before COVID-19	6 months	To assess fatigue (using PROMIS questionnaire Fatigue short-form 8a) before COVID-19 and over a six-month follow-up.
Fatigue after COVID-19	6 months	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.

Countries

United States

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed