Status: Ongoing First registered on: 16/06/2020
Last updated on: 04/09/2020
1. Study identification
EU PAS Register NumberEUPAS35835
Official titleImpact of use of proton pump inhibitors on susceptibility to infection and risk of hospitalisation in patients with COVID-19
Study title acronym
Study typeObservational study
Brief description of the studySince the COVID-19 epidemic was introduced in Denmark, measures have been taken to contain the spread and fight the disease. Studies from China and Italy describe that risk of severe or fatal COVID-19 disease increase with age, male sex and certain comorbid disease. The observed risk varied in the populations implying that the results are not necessarily transferable to other countries. This poses a great need to confirm known risk factors and identify unknown risk factors in a Danish population. Concern has been raised regarding antihypertensives and non-steroidal anti-inflammatory drugs (NSAIDs) via their suspected upregulation of ACE-2 receptors, but international recommendations have not yet been modified due to limited scientific evidence. Other medications possibly related to the host’s susceptibility to pneumonia include proton pump inhibitors (PPIs) that reduce the protective stomach acid production. Proton pump inhibitors have previously been associated with increased risk of infection in a meta-analysis from 2015 which showed that the risk of acquiring pneumonia and being admitted to hospital due to pneumonia was increased in persons receiving PPI. This study is a Danish nationwide registry-based study. We aim to examine the association between current use of PPI and risk of SARS-CoV-2 infection in patients tested for SARS-CoV-2 (in a case-control design) and risk of hospitalisation, mechanical ventilation, intensive care unit admission and death among patients with confirmed COVID-19 (in a cohort design), respectively. All individuals tested positive for SARS-CoV-2 will be followed from the date of positive test until hospital admission, date of death, or for up to 90 days. Current use of PPI is defined as redeemed prescription for PPI within the prior 90 days. Odds ratios will be estimated for both the primary outcome (hospital admission) and the secondary outcome (SARS-CoV-2 infection, severe outcomes).
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?2
Center of Research & Disruption in Infectious Diseases (CREDID), Department of Infectious Diseases, Amager Hvidovre Hospital, 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 analysis16/07/2020
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-260 
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 Professor 
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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