Status: Ongoing First registered on: 15/04/2020
Last updated on: 21/04/2020
1. Study identification
EU PAS Register NumberEUPAS34734
Official titleUse of non-steroidal anti-inflammatory drugs and clinical outcome of COVID-19: a Danish nationwide cohort study
Study title acronymNSAID COVID-19
Study typeObservational study
Brief description of the studyIn 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.
Was this study requested by a regulator?Yes:
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 belongsUniversity of Southern Denmark Pharmacoepi center
Department/Research groupOdense University Pharrnacoepidemiological Database
Organisation/affiliationUniversity of Southern Denmark
Website/Homepage
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 signed27/02/202027/02/2020
Start date of data collection27/02/202027/02/2020
Start date of data analysis01/06/2020
Date of interim report, if expected
Date of final study report15/06/2020
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 1J.B. Winsløwsvej 19, 2
Address line 2 
Address line 3 
CityOdense C 
Postcode5000 
CountryDenmark
Phone number (incl. country code)45-65503024 
Alternative phone number 
Fax number (incl. country code) 
Email address apottegaard@health.sdu.dk
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) 
Email address apottegaard@health.sdu.dk 
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