XEVUDY General Drug Use Investigation (SARS-CoV-2 Infection) - COVID-19 (217893)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Safety and clinical outcomes

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  XEVUDY
• Study drug International non-proprietary name (INN) or common name:
  SOTROVIMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (J06BD05) sotrovimab

  sotrovimab
• Medical condition to be studied:
  COVID-19

Population studied

• Age groups:
  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:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  630

Study design details

• Main study objective:
  The objective of this study is to collect and assess the following information about safety and clinical outcomes of Xevudy in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection who have risk factors for progression to severe SARS-CoV-2 infection and do not require oxygen administration (OA) in daily clinical practice.
• Outcomes:
  Occurrence status of adverse drug reactions (ADRs), Proportion of non-responders, and distribution and transition of vital signs and clinical symptoms.
• Data analysis plan:
  The incidence rate of adverse drug reactions (ADR) in participants will be calculated throughout the period of 29 days. The proportion of non-responders will be calculated (from Day 1 to the end of the observation period). The proportion of participant outcomes at the end of the observation period in participants other than non-responders will be calculated. The Robust (modified) Poisson regression model will be used to calculate the risk ratio and 95% confidence interval for each factor likely to affect safety (incidence rate of ADR participants) and clinical outcomes (proportion of non-responders), and to explore risk factors.

Documents

Study report

Sotrovimab PMS 217893 final report Anonymized 18 Apr 2024.pdf