Status: Finalised
First registered on:
22/12/2020
Last updated on:
02/03/2022
1. Study identification
EU PAS Register NumberEUPAS38759
Official titleSystemic glucocorticoids in the treatment of COVID-19 and risks of adverse outcomes in COVID-19 patients in the primary and secondary care setting
Study title acronymCorticosteroids in COVID19
Study typeObservational study
Brief description of the studyApproximately 10-20% of COVID-19 positive patients, many of whom are older or have co-morbidities, suffer from pneumonia and acute respiratory distress syndrome (ARDS), requiring hospitalization and ventilatory support. As a result, current treatment recommendations are to combine anti-viral therapy with immunosuppressive or immunomodulatory drugs to mitigate these immunologic complications, reducing COVID-19 associated morbidity and mortality. While the search for appropriate anti-viral therapy is ongoing, there have been some positive results with respect to systemic glucocorticoid use, such as dexamethasone, which has been associated with reduced mortality in ventilated patients and those on supplemental oxygen therapy. This has mobilised efforts to repurpose some of these steroids for the treatment of severe COVID-19 cases.
The aim of this study is to explore patterns of systemic glucocorticoid use and administration in patients with either a first confirmed diagnosis for COVID-19 (diagCOVID-19) or a first positive PCR test for SARS-CoV-2 (labCOVID-19). In addition, we will also study the risks of adverse events associated with these medications, as well as disease outcomes, in diagCOVID-19 or labCOVID-19 patients across seven European countries in ambulatory and hospital inpatient care settings.
Was this study requested by a regulator?Yes: EMA
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 groupIQVIA European Data Science Hub
Organisation/affiliationIQVIA
Details of (Primary) lead investigator
Title Professor
Last name Layton
First name Deborah
Is this study being carried out with the collaboration of a research network?
Yes
E-CORE
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?4
Erasmus University, Netherlands
Oxford University, UNited Kingdom
Countries in which this study is being conducted
International study
Belgium
France
Germany
Italy
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/06/202001/06/2020
Start date of data collection05/04/202101/09/2021
Start date of data analysis05/05/202120/09/2021
Date of interim report, if expected
Date of final study report27/07/202127/09/2021
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 bodyEMA100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Layton
First name Deborah
Address line 1210 Pentoville Road
Address line 2
Address line 3
CityLondon
Postcode
CountryUnited Kingdom
Phone number (incl. country code)442030754423
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Layton
First name Deborah
Address line 1210 Pentoville Road
Address line 2
Address line 3
CityLondon
Postcode
CountryUnited Kingdom
Phone number (incl. country code)442030754423
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)H02AB (prednisolone)
Substance class (ATC Code)H02AB02 (dexamethasone)
Substance class (ATC Code)H02AB07 (prednisone)
Substance class (ATC Code)H02AB04 (methylprednisolone)
Substance class (ATC Code)H02AB09 (hydrocortisone)
7. Medical conditions to be studied
Medical condition(s)Yes
COVID-19 virus test
COVID-19 PCR test
8. Population under study
Age
Adults (18 - 44 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
Other population
Renal impaired
Hepatic impaired
9. Number of subjects
Estimated total number of subjects153000
Additional information
The databases include between 1,417 to 124,221 diagCOVID-19 and labCOVID-19 patients per database, and a total of 153,759 patients, only one database observing hospitalized patients (around 2,000 patients).
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
Longitudinal Patient Database (LPD) Belgium (IQVIA), Belgium
Longitudinal Patient Database (LPD) France(IQVIA), France
Disease Analyser (DA) Germany, Germany
Longitudinal Patient Database (LPD) Italy (IQVIA), Italy
Hospital de Madrid (HM) Hospitales, Spain
Sources of data
Administrative database, e.g. claims database
Routine primary care electronic patient registry
Hospital databases
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Risk assessment
Drug utilisation study
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
To describe utilization of systemic glucocorticoids (e.g., dexamethasone, prednisolone, methylprednisolone or hydrocortisone) for treatment of COVID-19 in two settings: hospitalized (in hospital care) and ambulatory (any care received outside of hospital) within 90 days following COVID-19 diagnosis.
Are there primary outcomes?No
Are there secondary outcomes?Yes
Adverse events such as infections, hyperglycaemia, hypertension, GI bleeding, composite of cardiovascular events
Disease severity outcomes such as
- Hospital admission
- Venous thromboembolism (VTE) or pulmonary embolism (PE)
- Disseminated intravascular coagulation (DIC)
- Death of any cause
- Intensive services
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
Follow up for all patients will begin from the index date until they experience the outcome of interest (endpoint, depending on the objective) or until cohort exit (date of censoring). The patients will be followed up for maximum 90 days or until censoring occurs, censoring criteria are: death, patient exit (deregister) from a contributing data provider (GP practice) and end of the database’s
15. Data analysis plan
Please provide a brief summary of the analysis method
• Descriptive analysis for systemic glucocorticoid use patterns will be carried and stratified by setting, glucocorticoid exposure type (naive, prevalent) and subgroups of special interest.
• Kaplan-Meier methods will be used to estimate time to systemic glucocorticoid initiation from COVID-19 diagnosis, stratified by route of administration (oral vs intravenous).
• Cohort-specific descriptive statistics summarizing demographic, health and clinical patient characteristics, stratified by setting, glucocorticoid exposure type glucocorticoid (naive, prevalent), and subgroups of special interest will be presented.
• Crude incidence (presented as both proportions and rates) for the relevant outcomes for each of the treatment exposure groups will be calculated.
• The cumulative incidence rates will be reported at the end of follow-up (30 and 90 days).
• Data will be stratified by setting, glucocorticoid exposure type (naive, prevalent), and subgroups of special interest
etc.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
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 documents
DescriptionDocumentLatest version
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Submitted
