Status: Planned First registered on: 22/12/2020
Last updated on: 23/06/2021
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
Centre to which the investigator belongsIQVIA European Data Science Hub
Department/Research groupIQVIA European Data Science Hub
Organisation/affiliationIQVIA
Website/Homepage
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 collection05/04/2021
Start date of data analysis05/05/2021
Date of interim report, if expected
Date of final study report27/07/2021
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 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) 
Email address DLayton@uk.imshealth.com
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) 
Top