Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Inclusion Criteria:
Participants must also meet at least one of the following conditions:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nancy Dreyer, PhD, MPH | IQVIA Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IQVIA | Cambridge | Massachusetts | 02139 | United States | ||
| IQVIA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38412008 | Derived | Dreyer NA, Knuth KB, Xie Y, Reynolds MW, Mack CD. COVID-19 Vaccination Reactions and Risk of Breakthrough Infections Among People With Diabetes: Cohort Study Derived From Community Reporters. JMIR Diabetes. 2024 Feb 27;9:e45536. doi: 10.2196/45536. | |
| 37336535 | Derived | Largent J, Xie Y, Knuth KB, Toovey S, Reynolds MW, Brinkley E, Mack CD, Dreyer NA. Cognitive and other neuropsychiatric symptoms in COVID-19: analysis of person-generated longitudinal health data from a community-based registry. BMJ Open. 2023 Jun 19;13(6):e069118. doi: 10.1136/bmjopen-2022-069118. |
| Label | URL |
|---|---|
| Study Website | View source |
Not provided
It is anticipated that external researchers may want to leverage these data for public health and life sciences research. The intent is to provide limited data access to qualified researchers for research that has gone through a review process.
Data will be available during conduct of the study and two years following study completion.
Qualified researchers that have undergone a review process may submit requests to the IQVIA Registry Data Governance Committee (DGC) requesting approval and access for specific research purposes.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 9, 2021 | Apr 5, 2021 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| London |
| United Kingdom |
| 36148919 | Derived | 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. |
| 36090603 | Derived | 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. |
| 35177299 | Derived | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |