Post-Marketing Surveillance of REGKIRONA ® 960mg (Regdanvimab)(monoclonal antibody, gene recombination) to Evaluate Its Safety and Efficacy (CT-P59 4.1)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J05AX) Other antivirals

  Other antivirals
• Medical condition to be studied:
  COVID-19

Population studied

• Age groups:
  • 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)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The objectives of this post-marketing surveillance (PMS) are to evaluate the safety and efficacy of Regdanvimab in Korea under routine care and identify the issues regarding SAEs, ADRs, unexpected AEs and ADRs, already known ADRs, non-serious AEs and other information about safety and efficacy.
• Outcomes:
  The objectives of this post-marketing surveillance (PMS) are to evaluate the safety and efficacy of Regdanvimab in Korea under routine care and identify the issues regarding SAEs, ADRs, unexpected AEs and ADRs, already known ADRs, non-serious AEs and other information about safety and efficacy.
• Data analysis plan:
  A table showing the list of advers events by type shall be created and the severity, causal relationships and outcome of adverse events shall be analyzed. Unexpected ADRs shall be presented in the summary table. The surveilance will analyse, as necessary, the incidence rate of AEs, depending on the subject's background factors. Analysis of the incidence rate according to the type of abnormal changes in the clinical laboratory test values and the incidence rate of ADE will be performed. In order to examine factors that are thought to affect efficacy, the surveilance will analyse the rate of disease progression, depending on the subject's background factors.