Status: Ongoing
First registered on:
19/10/2020
Last updated on:
30/11/2020
1. Study identification
EU PAS Register NumberEUPAS37658
Official titleDynamics of prescription drug use, diagnoses and health care utilization after community managed SARS-CoV-2 infection
Study title acronym
Study typeObservational study
Brief description of the studyUsing the Danish national health registries, we examine drug use, hospital diagnoses and health care utilization prior to and after SARS-CoV-2 infection among individuals with community managed SARS-CoV-2 infection. Analyses are repeated for an age and sex matched cohort of individuals tested negative for SARS-CoV-2 and individuals hospitalized with SARS-CoV-2 infection.
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 applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research group
Organisation/affiliationUniversity of Southern Denmark
Details of (Primary) lead investigator
Title Professor
Last name Pottegård
First name Anton
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
National study
Denmark
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/10/202001/10/2020
Start date of data collection27/02/202027/02/2020
Start date of data analysis20/10/202020/10/2020
Date of interim report, if expected
Date of final study report15/11/2020
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
OtherUniversity of Southern Denmark100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Pottegård
First name Anton
Address line 1JB Winsløwsvej 19,2
Address line 2
Address line 3
CityOdense C
PostcodeDK-5000
CountryDenmark
Phone number (incl. country code)45-65503024
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Pottegård
First name Anton
Address line 1JB Winsløwsvej 19,2
Address line 2
Address line 3
CityOdense C
PostcodeDK-5000
CountryDenmark
Phone number (incl. country code)45-65503024
Alternative phone number
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
SARS-CoV-2 PCR test positive
SARS-CoV-2 PCR test negative
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects531619
Additional information
Community managed individuals who tested positive for SARS-CoV-2: 9080
Hospitalized individuals who tested positive for SARS-CoV-2: 1696
Individuals tested negative for SARS-CoV-2: 520,843
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Administrative database, e.g. claims database
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Drug utilisation study
Healthcare utilization
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
The aim of the study is to examine drug use, hospital diagnoses and health care utilization after SARS-CoV-2 infection.
Are there primary outcomes?Yes
Primary outcomes are the initiation of prescription drugs or hospital diagnoses that may represent delayed complication or persisting symptoms to SARS-CoV-2 infection and healthcare utilization after SARS-CoV-2 infection.
For a detailed list of all outcomes, please see the study protocol
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
Drug utilisation study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
90 days after recovery from SARS-CoV-2 infection.
15. Data analysis plan
Please provide a brief summary of the analysis method
The measure of occurrence for initiation of new medication, reinitiation of medication, first-ever diagnoses and readmissions will be the cumulative incidence proportion (IP) during follow up (duration: 90 days). IP differences comparing individuals with community managed SARS-CoV-2 infection to SARS-CoV-2 negative individuals and individuals hospitalized for SARS-CoV-2 infection, will be estimated using generalized linear models using a binomial distribution and an identity link.
The rates of healthcare utilization (number of visits per 1000 individuals during follow up) will be quantified during the prior comparator period and follow up (duration: 90 days each) for each cohort. Rate ratios, rate differences and exact 95% confidence intervals comparing the prior comparator period to follow up will be calculated for each cohort.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
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)
Document
coi.pdf
Composition of Steering Group and
ObserversNot submitted
Other documents
DescriptionDocumentLatest version
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Submitted
