A Cohort Study to Evaluate the Real-World Utilization and Effectiveness of Bebtelovimab Compared to Paxlovid among Patients with Mild-to-Moderate COVID-19 Who Are at High Risk for Progressing to Severe Illness (J2X-MC-B003)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  PAXLOVID
• Study drug International non-proprietary name (INN) or common name:
  BEBTELOVIMAB

  NIRMATRELVIR

  RITONAVIR
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AE30) nirmatrelvir and ritonavir

  nirmatrelvir and ritonavir
• Medical condition to be studied:
  SARS-CoV-2 test positive
• Additional medical condition(s):
  Positive results of direct SARS-CoV-2 viral testing and high risk for progression to severe 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)
• Estimated number of subjects:
  2780

Study design details

• Main study objective:
  To estimate the 30-day risk difference of the composite outcome of all-cause hospitalization or all-cause death for patients who received bebtelovimab compared to patients who received Paxlovid.
• Outcomes:
  All-cause hospitalization or all-cause death, 30-day risk difference of all-cause hospitalization, all-cause death, and all-cause emergency department visits.
• Data analysis plan:
  For patients included in both study cohorts, descriptive statistics will be used to describe baseline characteristics. Differences between baseline characteristics will be calculated using standardized differences before and after propensity score matching. An intent-to-treat approach will be used to derive the cumulative incidence (risk) and risk difference and 95% CI of 30-day all-cause hospitalization or all-cause death (primary analysis composite outcome). For comparing the outcomes between the 2 cohorts, confounding control will be achieved using coarsened exact matching on highly selected and a priori defined baseline variables in conjunction with propensity score matching on a broader set of baseline variables. For the primary analysis only, the noninferiority null hypothesis for this objective will be tested using the 1-sided Type I error of 0.025 by setting the RDUCL 95% CI of the bebtelovimab versus Paxlovid to be less than the prespecified noninferiority margin of 1.795%.