Study identification

PURI

https://redirect.ema.europa.eu/resource/41088

EU PAS number

EUPAS35835

Study ID

41088

Official title and acronym

Impact of use of proton pump inhibitors on susceptibility to infection and risk of hospitalisation in patients with COVID-19

DARWIN EU® study

No

Study countries

Denmark

Study description

Since 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).

Study status

Finalised
Research institutions and networks

Institutions

Center of Research & Disruption in Infectious Diseases (CREDID), Department of Infectious Diseases, Amager Hvidovre Hospital Denmark

Contact details

Simone Bastrup Israelsen

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

Erik and Susanna Olesen's Public Charity Fund
Study protocol
Initial protocol

Impact of use of proton pump inhibitors on susceptibility to infection_v1.4_15.07.2020

English (322.14 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable