Study identification

PURI

https://redirect.ema.europa.eu/resource/34735

EU PAS number

EUPAS34734

Study ID

34735

Official title and acronym

Use of non-steroidal anti-inflammatory drugs and clinical outcome of COVID-19: a Danish nationwide cohort study (NSAID COVID-19)

DARWIN EU® study

No

Study countries

Denmark

Study description

In the early stages of the COVID-19 pandemic in Europe, case reports from southern France described young patients without comorbidities who developed severe COVID-19 after exposure to ibuprofen. This led to warnings against use of ibuprofen and other NSAIDs in patients with COVID-19 by multiple parties, including the French health ministry. However, no data has been published regarding the safety of NSAIDs in COVID-19. We aim to study the association between NSAID use and risk of death in patients with COVID-19. In secondary analyses, associations between NSAIDs and hospitalisation, ICU admission and mechanical ventilation will be investigated. This is a Danish nationwide registry-based cohort study. All individuals tested positive for severe acute respiratory syndrome coronavirus 2 will be followed from the date of positive test and 30 days onward for occurrence of death, and from the date of positive test and 14 days onward for occurrence of hospital admission, ICU admission, and mechanical ventilation. Use of NSAIDs will be compared to non-use using an exposure assessment window of 30 days prior to the positive test. Risks, risk difference and relative risk will be estimated for each outcome.

Study status

Ongoing
Research institution and networks

Institutions

Contact details

Anton Pottegård

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

University of Southern Denmark
Study protocol
Initial protocol
English (513.95 KB - 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