Status: Ongoing First registered on: 29/06/2020
Last updated on: 20/08/2020
1. Study identification
EU PAS Register NumberEUPAS36056
Official titleThe prognosis of coronavirus disease (COVID-19) in patients recently treated with immunosuppressant medications.
Study title acronym
Study typeObservational study
Brief description of the studyImmunosuppressant medications are effective treatments for several immune-mediated inflammatory diseases, as well as vasculitides, chronic lung diseases and certain malignancies. These medications have a strong effect on the immune system decreasing inflammation, but this has prompted concerns regarding the body’s defence against infection. This is particularly pertinent during the current epidemic of coronavirus (COVID-19), as a weakened immune system may be vulnerable to severe coronavirus disease. We aim to evaluate the prognosis of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection in patients treated with immunomodulating medications, including immunosuppressants and systemic glucocorticoids. We will leverage unique Danish health registers to conduct a nationwide cohort study of the outcome of SARS-COV-2 infection, i.e. admission to hospital, admission to intensive care unit (intensive care observation/intensive care therapy) or death, in this patient population, with adjustment for the severity of patients’ underlying indication for immunosuppression, as well as other factors that may affect the course of coronavirus disease.
Was this study requested by a regulator?Yes: Denmark
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 Hallas
First name Jesper
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 analysis30/06/2020
Date of interim report, if expected
Date of final study report30/07/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesLundbeck Foundation50
Charities
Government body
Research councils
EU funding scheme
OtherUniversity of Southern Denmark50
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)4565503024 
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 1J. B. Winsløwsvej 19, 2 
Address line 2 
Address line 3 
CityOdense C 
Postcode5000 
CountryDenmark 
Phone number (incl. country code)4565503024 
Alternative phone number 
Fax number (incl. country code) 
Email address apottegaard@health.sdu.dk 
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