Pharmacogenetic study to predict the response to Tocilizumab in patients infected with SARS-CoV-2 (COVID-19)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Drug interaction study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AC07) tocilizumab

  tocilizumab
• Medical condition to be studied:
  Pneumonia viral
• Additional medical condition(s):
  SARS-CoV-2 infection

Population studied

• Age groups:
  • 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:
  384

Study design details

• Main study objective:
  Identify a biomarker panel of genetic variants that allows to predict the response to Tocilizumab
• Data analysis plan:
  Different bioinformatics tools will be used to develop a working "pipeline" thatFirst, allow the quality processing and analysis of the sequences obtained, followed byalignment against a reference sequence to finally identify the variants. Then the appropriate statistical analyzes will be carried out to identify variantsdifferential genetics between drug response groups using severe algorithms ofcorrection for multiple comparisons, Benjamini-Hochberg type.