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Study cancelled due to change in feasibility.
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The main purpose of this study is to understand:
This study will take in 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 twelve follow-ups over a 6-month period.
This is a prospective non-interventional longitudinal cohort survey study. Repeated measures on PROs: symptoms (prevalence, frequency, duration, and severity), EQ-5D-5L, WPAI and PROMIS-Fatigue short form 8a over 6 months will be collected and evaluated.
COVID-19 Cohort: Participants 18 years or older with laboratory-confirmed COVID-19 illness and at least one patient-reported symptom.
Influenza Cohort: Participants 18 years or older with laboratory-confirmed influenza illness and at least one patient-reported symptom.
All study objectives and outcomes will be assessed separately for the two study cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 Positive | Laboratory-confirmed COVID-19 illness and at least one patient-reported symptom |
| |
| Influenza Positive | Laboratory-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 |
|---|---|---|
| Prevalence, Severity, 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 | To characterize prevalence and duration of influenza symptoms before influenza and up to 6 months (acute phase and Long Flu). | 6 Months |
| 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 lab confirmed COVID-19 or influenza. | 6 Months |
| Change in Health Related Quality of Life (HRQoL) using WPAI:GH | To assess the change in HRQoL using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) before COVID-19 or influenza and over a 6-month period following lab 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 over six months following lab confirmed COVID-19 or influenza. | 6 Months |
| Visual Analog Scale (VAS) scores | To estimate the VAS scores and their change over six months following the lab confirmed COVID-19 or influenza. | 6 Months |
| Work Productivity and Activity Impairment (WPAI) scores |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue after COVID-19 or influenza | To estimate the PROMIS questionnaire Fatigue short-form 8a score and its change over six months following lab confirmed COVID-19 or influenza. | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants 18 years or older who are self-reported symptomatic, with laboratory-confirmed illness when tested at any of Walgreens 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 |
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| 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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To estimate the WPAI scores and their change over six months following the lab confirmed COVID-19 or influenza. |
| 6 Months |
| 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 |