Clinical trial NCT04368065: COVID-19 Active Research Experience (CARE)
Official title: Registry to Study Factors That May Impact COVID-19 Occurrence and Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Iqvia Pty Ltd
Sponsor class: INDUSTRY
First posted: 2020-04-29
Enrollment: 35278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults living in the US or UK who have COVID-19 or COVID-19 like symptoms, were vaccinated against COVID-19, or were exposed to COVID-19.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: COVID-19 symptom occurrence and severity
timeFrame: 12 months
measure: COVID-19 treatments
timeFrame: 12 months
measure: COVID-19 risk factors
timeFrame: 12 months
measure: Occurrence and severity of COVID-19 infection after vaccination
timeFrame: 12 months
measure: Occurrence of medically attended events after vaccination
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: IQVIA
state: Massachusetts
city: London
country: United Kingdom
facility: IQVIA
Study officials:
affiliation: Iqvia Pty Ltd
name: Nancy Dreyer, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reynolds MW, Secora A, Joules A, Albert L, Brinkley E, Kwon T, Mack C, Toovey S, Dreyer NA. Evaluating real-world COVID-19 vaccine effectiveness using a test-negative case-control design. J Comp Eff Res. 2022 Nov;11(16):1161-1172. doi: 10.2217/cer-2022-0069. Epub 2022 Sep 23.
citation: Reynolds MW, Xie Y, Knuth KB, Mack CD, Brinkley E, Toovey S, Dreyer NA. COVID-19 Vaccination Breakthrough Infections in a Real-World Setting: Using Community Reporters to Evaluate Vaccine Effectiveness. Infect Drug Resist. 2022 Sep 3;15:5167-5182. doi: 10.2147/IDR.S373183. eCollection 2022.
citation: Dreyer N, Reynolds MW, Albert L, Brinkley E, Kwon T, Mack C, Toovey S. How frequent are acute reactions to COVID-19 vaccination and who is at risk? Vaccine. 2022 Mar 15;40(12):1904-1912. doi: 10.1016/j.vaccine.2021.12.072. Epub 2022 Feb 9.