1. Study identification
EU PAS Register NumberEUPAS36240
Official titleRegistry to study factors that may impact COVID-19 occurrence and severity
Study title acronymCARE
Study typeObservational study
Brief description of the studyThis is an observational, direct-to-participant, web-based, longitudinal study of adults with potential exposure to COVID-19 to better understand risk factors, symptoms, and treatments for COVID-19 illness.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableParticipants enter information here:
https://www.helpstopcovid19.com/
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIQVIA
Department/Research group
Organisation/affiliationIQVIA
Details of (Primary) lead investigator
Title Dr
Last name Nancy
First name Dreyer
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
International study
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/04/202001/04/2020
Start date of data collection22/04/202022/04/2020
Start date of data analysis28/04/202028/04/2020
Date of interim report, if expected
Date of final study report01/07/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherIQVIA100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Nancy
First name Dreyer
Address line 1201 Broadway, 5th floor
Address line 2
Address line 3
CityCambridge
Postcode02139
CountryUnited States
Phone number (incl. country code)16177156810
Alternative phone number16177339478
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Nancy
First name Dreyer
Address line 1201 Broadway, 5th floor
Address line 2
Address line 3
CityCambridge
Postcode02139
CountryUnited States
Phone number (incl. country code)16177156810
Alternative phone number16177339478
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
COVID-19
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
Other population
Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women
9. Number of subjects
Estimated total number of subjects20000
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Prospective patient-based data collection
Disease/case registry
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Risk assessment
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
The objective of this study is to identify factors that may impact the occurrence or severity of COVID-19 infections including examining the role of underlying health conditions, prescription and over-the-counter medications, vitamins and supplements.
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
3 months
15. Data analysis plan
Please provide a brief summary of the analysis method
TBC
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Available when the study ends
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted