Clinical features of COVID-19 in Pediatric Patients (COPP-study)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Pharmacokinetic study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CHLOROQUINE
• Medical condition to be studied:
  Coronavirus infection

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)
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The main study parameters are 1) Description of the clinical features and risk factors of COVID-19 in hospitalized and outpatient pediatric patients in the Netherlands. 2) Description of the clinical course of COVID-19 in hospitalized and outpatient pediatric patients. 3) Description of the response to treatment, including supportive care.
• Outcomes:
  Description of the clinical features of the COVID-19 in hospitalized and outpatient pediatric patients in the Netherlands.Description of the clinical course of the COVID-19 in hospitalized and outpatient pediatric patients.Description of the response to treatment, including supportive care. Characterization of the host responses (inflammatory parameters) to infection and COVID-19 in pediatric patients.Determine cytokine levels (e.g. IL-6) and medication concentrations (e.g. chloroquine) in scarce material.
• Data analysis plan:
  For real-time reporting of anonymous data on the website R will be used (R Foundation for Statistical Computing, Vienna, Austria). IBM SPSS Statistics software (SPSS Statistics for Windows, IBM, Armonk, NY) will be used.Demographic and clinical characteristics will be described using standard statistical analysis methods. The descriptive data will be presented as percentages and medians ± interquartile range, or numbers with percentages.