Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(C02) ANTIHYPERTENSIVES
(A10BK) Sodium-glucose co-transporter 2 (SGLT2) inhibitors
(P01BA02) hydroxychloroquine
(M01AE53) ketoprofen, combinations
(A10BA02) metformin
(B01AC22) prasugrel
(C10BX15) atorvastatin and perindopril

Medical condition to be studied

Type 2 diabetes mellitus
Hypertension
Rheumatoid arthritis
Osteoarthritis
Polycystic ovaries
Atrial fibrillation
Cardiovascular examination
Population studied

Age groups

Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

15000
Study design details

Main study objective

The overall aim of this study is to investigate the effects of routine medications used to manage underlying chronic conditions on the rate and severity of COVID-19 infection.

Outcomes

Outcomes: (1) Composite of confirmed, suspected or probable diagnosis of COVID-19(2) Confirmed diagnosis of COVID-19 (3) COVID-19 associated mortality(4) Hospitalization due to COVID-19

Data analysis plan

We will use descriptive statistics to summarize the characteristics of the patients in each of the current prescription cohorts. We will provide the descriptive statistics for the exposure pairs: 1) as derived without matching, 2) after coarsened exact matching, 3) propensity score matching. Crude incidence rates of each outcome will be calculated with 95% CIs. In the primary analysis, we will apply a Cox proportional hazards regression model to determine crude and adjusted hazard ratios (HR) for pharmacological risk modifiers comparing pairs of treatment groups in patients with the underlying indicative condition for each of the outcomes mentioned. In addition, we will report survival curves adjusted for baseline confounders, and/or HRs at increasing periods of follow-up.