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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05160636 | Registry Identifier | ClinicalTrials.gov |
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| Name | Class |
|---|---|
| CVS Caremark | INDUSTRY |
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The main purpose of this study is to understand:
This study will enroll participants who are:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 Positive | Test-confirmed COVID-19 illness and at least one patient-reported symptom |
| |
| Influenza Positive | Test-confirmed influenza illness and at least one patient-reported symptom |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Vaccine | Biological | Receipt of Pfizer BioNTech COVID-19 vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence and duration of SARS-CoV-2 symptoms | To characterize prevalence and duration of SARS-CoV-2 symptoms before COVID-19 and up to 6 months (acute phase and Long COVID). | 6 months |
| Prevalence, Severity, and duration of influenza symptoms aggregated as index score area under the curve |
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Inclusion Criteria:
Exclusion Criteria:
- No symptoms reported in the study screening questionnaire
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | New York | New York | 10001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39684943 | Derived | 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. | |
| 39436613 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Nasopharyngeal swabs that are obtained as SOC for COVID-19 testing.
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. |
| 6 Months |
| Fatigue before COVID-19 | To assess fatigue (using PROMIS questionnaire Fatigue short-form 8a) before COVID-19 and over a six-month follow-up. | 6 months |
| Fatigue after COVID-19 | 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. | 6 months |
| 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. |
| 37679771 | Derived | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |