Study type

Study type

Non-interventional study

Scope of the study

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

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N05A) ANTIPSYCHOTICS
ANTIPSYCHOTICS
(N06A) ANTIDEPRESSANTS
ANTIDEPRESSANTS
(N05B) ANXIOLYTICS
ANXIOLYTICS
(N05CD09) brotizolam
brotizolam

Medical condition to be studied

SARS-CoV-2 test positive
Population studied

Age groups

  • Paediatric Population (< 18 years)
    • Neonate
      • 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)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Special population of interest

Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women

Estimated number of subjects

25000
Study design details

Main study objective

To provide a population-based description of the association and potential differential impact of frequently used psychotropic drugs on the course and outcomes of COVID-19 in people with hospital diagnosed and without hospital diagnosed psychiatric disorders.

Outcomes

Hospitalization within 14 days and death within -2 to 30 days since the verified positive test, (Among those hospitalized): Length of hospitalization, ICU treatment and ventilation (-2 days before the index date).

Data analysis plan

We will describe the prevalence of specific drug use within 6 months before testing for community treated, hospitalized and deceased patients, stratified by age, sex and psychiatric comorbidity. In the primary analyses, we will investigate the association between cumulative and current psychotropic drug use prior to testing and risk of hospitalization and death using logistic regression analysis among all positively tested individuals. The analyses will be stratified, following clinical and power considerations, by psychiatric diagnoses (any diagnosis) and by individual psychiatric disorders PS methodology will be applied by either matching of adjustment for each drug-outcome association of the respective drug pairs. We will apply formal testing for interactions between psychiatric diagnoses/hospital contacts and psychotropic drug use. We will report crude and adjusted odds ratios (ORs) and 95% confidence intervals (95% CI).