The effect of mental disorders and treatment with psychotropic agents on the course of COVID-19 (COVID-19 psychotropics)

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000097449

  ANTIPSYCHOTICS

  100000097650

  ANTIDEPRESSANTS

  100000097528

  ANXIOLYTICS

  100000097608

  brotizolam
• Medical condition to be studied:
  SARS-CoV-2 test positive

Population studied

• 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)
• 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).