COVID-19 Active Research Experience (CARE)

Study Overview
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Brief Summary
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COVID-19 Active Research Experience (CARE) is an observational, direct-to-participant, web-based, longitudinal study of adults with COVID-19 or COVID-19 like illness or who were vaccinated against COVID-19 to better understand risk factors, symptoms, and treatments for COVID-19 illness and vaccine safety and effectiveness.

Detailed Description
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This is an observational, direct-to-participant, web-based, longitudinal study of adults with COVID-19 or COVID-19 like illness to better understand risk factors, symptoms, and treatments for COVID-19 illness and vaccine safety and effectiveness. Upon consent and enrollment, participants will complete an initial baseline survey reporting their demographics, relevant medical history, testing, vaccination, symptoms, use of prescription medications as well as use of supplements and other factors. The study follow-up period is 12 months. During the first month of follow-up participants will be invited to complete a symptom diary weekly to gauge symptom progression and severity and to provide updates on pharmaceutical and non-pharmaceutical interventions as well as healthcare encounters. Reporting will then reduce to monthly for Month 2 through 12.

Official Title
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Registry to Study Factors That May Impact COVID-19 Occurrence and Severity

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (18 years or older) Currently living in the US or UK Have regular access to a computer, smartphone or tablet and sufficient internet to support registry demands (note: this registry is designed to operate well even in regions with low bandwidth) Willing and able to provide informed consent Willing and able to follow the procedures of the study Participants must also meet at least one of the following conditions: Have COVID-19 or COVID-19 like symptoms Received a COVID-19 vaccine Potential exposure to COVID-19 Exclusion Criteria: Unable to provide informed consent Unable to perform the requested study tasks and unable or unwilling to assign a proxy informant to complete the tasks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 symptom occurrence and severity | Occurrence and severity of potential COVID-19 symptoms as reported by participants in the survey | 12 months | 
| COVID-19 treatments | Prescription treatments for COVID-19 as reported by participants in the survey | 12 months | 
| COVID-19 risk factors | Assess potential role of comorbidities and concomitant medications on COVID-19 occurrence and severity | 12 months | 
| Occurrence and severity of COVID-19 infection after vaccination | Occurrence and severity of COVID-19 infection as reported by participants after SARS-CoV-2 vaccine | 12 months | 
| Occurrence of medically attended events after vaccination | Occurrence of medically attended events as reported by participants after after SARS-CoV-2 vaccine | 1 month |