Status: Ongoing First registered on: 30/06/2020
Last updated on: 09/09/2020
1. Study identification
EU PAS Register NumberEUPAS36089
Official titleImpact of use of newer glucose lowering drugs on outcomes in patients with COVID-19
Study title acronym
Study typeObservational study
Brief description of the studyThe coronavirus disease 2019 (COVID-19) pandemic poses great health care challenges worldwide. In Denmark, authority regulated social distancing has been the key to limit rapid spread of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) keeping the diseased population below the tolerable threshold. However, the COVID-19 epidemic is expected to return in one or more waves which emphasizes the need for identifying modifiable risk factors in vulnerable patients. Newer glucose lowering drugs (GLD) have potential for affecting the disease course by suppressing the inflammatory state or by upregulation of the angiotensin-converting enzyme 2 (ACE2). The study is a national cohort study on patients tested positive for SARS-CoV-2 in Denmark. This study will examine the association between ongoing use of newer glucose-lowering drugs (Glucagon Like Peptid-1 (GLP-1) receptor agonists, Dipeptidyl Peptidase-4 (DPP4) inihibitors and Sodium-Glucose Transport Protein-2 (SGLT2) inhibitors) and other glucose lowering drugs and risk of severe outcomes in COVID-19 patients. Severe outcomes include hospital admission, intensive care unit (ICU) admission, mechanical ventilation and death within 30 days from positive SARS-CoV-2 test.
Was this study requested by a regulator?No
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 Dr
Last name Bastrup Israelsen
First name Simone
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3
Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
Center for Research and Disruption in Infectious Diseases, Department of Infectious Diseases, Amager Hvidovre Hospital, Hvidovre, Denmark
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 signed22/04/2020
Start date of data collection27/02/2020
Start date of data analysis01/07/2020
Date of interim report, if expected
Date of final study report01/10/2020
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
OtherErik and Susanna Olesen's Public Charity Fund100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Bastrup Israelsen
First name Simone
Address line 1Kettegaard Alle 30
Address line 2 
Address line 3 
CityHvidovre 
PostcodeDK-2650 
CountryDenmark
Phone number (incl. country code)45-40335495 
Alternative phone number 
Fax number (incl. country code) 
Email address simone.elisabeth.bastrup.israelsen.02@regionh.dk
Public Enquiries
Title Dr 
Last name Benfield 
First name Thomas 
Address line 1Kettegaard Alle 30 
Address line 2 
Address line 3 
CityHvidovre 
PostcodeDK-2650 
CountryDenmark 
Phone number (incl. country code)45-38622302 
Alternative phone number 
Fax number (incl. country code) 
Email address thomas.lars.benfield@regionh.dk 
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