Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Case-population study
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(C03DA) Aldosterone antagonists
(C09) AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
(M01AA) Butylpyrazolidines
(M01AB) Acetic acid derivatives and related substances
(M01AC56) meloxicam, combinations
(M01AE01) ibuprofen
(M01AE02) naproxen
(M01AG) Fenamates
(M01AH) Coxibs
(M01AX) Other antiinflammatory and antirheumatic agents, non-steroids

Medical condition to be studied

Coronavirus infection

Additional medical condition(s)

COVID-19
Population studied

Age groups

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

11000
Study design details

Main study objective

To assess the association of renin-angiotensin system (RAS) blockers and non-steroidal anti-inflammatory drugs (NSAIDs) with hospital admission due to COVID-19 infection adjusted for age, sex, and cardiovascular risk factors.

Outcomes

- Hospital admission due to COVID-19- Hospital admission to the intensive care unit (ICU) due to COVID-19- In-hospital death after admission due to COVID-19- Admission to ICU or in-hospital death (combined)

Data analysis plan

Main analysis:Crude odds ratios (ORs) and their 95% confidence intervals (CIs) will be computed through univariate conditional logistic regression to assess the association of current use of RAS blockers with the outcome of interest as compared to non-use and as compared to other antihypertensive drugs. After that, we built a multivariate model including the potential confounders (other comorbidities and comedications) all at once. Intermediate analyses: Intermediate analyses will be performed at different points along the study when the number of cases included are: 100, 500 and 750.Sensitivity analysis: Two sources of information from different years will be used (2020 for cases and 2018 for controls). To correct for a secular trend in the prevalence of antihypertensive drugs, we will estimate the prevalence for 2020 and we will obtain a correction factor to adjust the odds ratios for.