Study identification

PURI

https://redirect.ema.europa.eu/resource/46063

EU PAS number

EUPAS38759

Study ID

46063

Official title and acronym

Systemic glucocorticoids in the treatment of COVID-19 and risks of adverse outcomes in COVID-19 patients in the primary and secondary care setting (Corticosteroids in COVID19)

DARWIN EU® study

No

Study countries

Belgium
France
Germany
Italy
Spain
United Kingdom

Study description

Approximately 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.

Study status

Finalised
Research institutions and networks

Institutions

Erasmus University Netherlands, Oxford University UNited Kingdom

Networks

Contact details

Deborah Layton

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

COVID 19 and steroid treatments_v4.0 clean

English (1.3 MB - PDF)View document
Updated protocol

COVID 19 and steroid treatments_v5.0 Clean

English (1.26 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable