Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Drug utilisation
Healthcare resource utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

SARS-CoV-2 test positive
SARS-CoV-2 test negative
Population studied

Short description of the study population

Any individual with a positive or negative reverse-transcriptase polymerase chain reaction (RTPCR) test for SARS-CoV-2 in Denmark during the period 27-02-2020 to 31-05-2020 was eligible for inclusion in the study.

Age groups

Preterm newborn infants (0 – 27 days)
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

531619
Study design details

Main study objective

The aim of the study is to examine drug use, hospital diagnoses and health care utilization after SARS-CoV-2 infection.

Outcomes

Primary outcomes are the initiation of prescription drugs or hospital diagnoses that may represent delayed complication or persisting symptoms to SARS-CoV-2 infection and healthcare utilization after SARS-CoV-2 infection. For a detailed list of all outcomes, please see the study protocol

Data analysis plan

The measure of occurrence for initiation of new medication, reinitiation of medication, first-ever diagnoses and readmissions will be the cumulative incidence proportion (IP) during follow up (duration: 90 days). IP differences comparing individuals with community managed SARS-CoV-2 infection to SARS-CoV-2 negative individuals and individuals hospitalized for SARS-CoV-2 infection, will be estimated using generalized linear models using a binomial distribution and an identity link. The rates of healthcare utilization (number of visits per 1000 individuals during follow up) will be quantified during the prior comparator period and follow up (duration: 90 days each) for each cohort. Rate ratios, rate differences and exact 95% confidence intervals comparing the prior comparator period to follow up will be calculated for each cohort.
Documents