Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Case-control
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(A02BC) Proton pump inhibitors
Proton pump inhibitors

Medical condition to be studied

COVID-19
Suspected COVID-19
Population studied

Short description of the study population

The study population consists of all patients tested for SARS-CoV-2 in the case-control design investigating the risk of infection. In the cohort design, the study population comprises patients with a positive test for SARS-CoV-2 examining the risk of hospitalisation and severe outcomes.

Age groups

Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

230000
Study design details

Main study objective

The main objective of the study is to examine the association between concomitant use of PPI and risk of SARS-CoV-2 infection in patients tested for SARS-CoV-2 and risk of hospitalisation, intensive care unit (ICU) admission, mechanical ventilation and death among patients with confirmed COVID-19, respectively.

Outcomes

The primary outcome is hospital admission within 30 days after positive test for SARS-CoV-2 or a positive test for SARS-CoV-2 within 48 hours of hospital admission in patients already admitted before the date of the test, Secondary outcomes comprise ICU admission, mechanical ventilation and death within 30 and 90 days after positive SARS-CoV-2 test. In the risk of infection analysis, the outcome is a positive SARS-CoV-2 test among all patients tested during the study period, and where the negative tests are included as potential controls.

Data analysis plan

We will estimate odds ratios for hospital admission and severe outcomes in patients with positive SARS-CoV-2 test for the exposed group (current PPI use) relative to the unexposed group by using logistic regression. In the case-control design, we will perform conditional logistic regression to examine a possible association between current PPI use and COVID-19 susceptibility, and results will be presented as odds ratios with 95% confidence intervals. In the nested case-control study, confounding by age, sex and calendar time will be handled by virtue of the risk set sampling and the matched analysis. Other potential confounders will be handled by multivariable modelling. In the cohort analysis, we will apply matching to adjust for pre-existing differences in significant risk factors between the exposed and unexposed groups. Matching will be performed by use of propensity scores. Sensitivity analysis will be performed on patients with current vs. past vs. never PPI use.
Documents
Study publications
Israelsen SB, Ernst MT, Lundh A, Lundbo LF, Sandholdt H, Hallas J, Benfield T. …