A secondary data use study of pregnancy and infant outcomes following administration of casirivimab + imdevimab (Ronapreve, REGEN-COV) during pregnancy based on data obtained from the COVID-19 international drug pregnancy registry [COVID-PR]

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  IMDEVIMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (J06BD07) casirivimab and imdevimab

  casirivimab and imdevimab
• Medical condition to be studied:
  COVID-19

  Pregnancy

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  The main objective of the study is to evaluate the effect that medications indicated for the treatment of mild to severe COVID-19 have on obstetric, neonatal, and infant outcomes.
• Outcomes:
  Obstetric outcomes (e.g. miscarriage, stillbirth, neonatal death, maternal death, preterm delivery, etc.), neonatal outcomes (e.g. major congenital malformations, low birth weight, small for gestational age, etc.), and infant outcomes until 1 year of age (e.g. developmental milestones) and maternal outcomes (e.g. COVID-19 reinfection). Descriptive analysis of pregnancy and infant outcomes for Cas/Imd against comparator groups consisting of pregnant women treated with another therapy for mild to severe COVID-19 (active comparator), and pregnant women hospitalized but not treated with a medication specifically indicated for the treatment of mild to severe COVID-19 (unexposed comparator for hospitalized exposed patient).
• Data analysis plan:
  Descriptive statistics will be used to summarize overall frequency of selected adverse pregnancy outcomes, as well as frequencies of specific outcomes such as major congenital malformations, miscarriages, stillbirths, preterm deliveries, small for gestational age infants, maternal obstetric and postpartum health, admission into the neonatal Intensive Care Unit (ICU), infant developmental milestones (at 6, 9, and 12 months of age), neonatal death and infant death, and maternal and infant incidence of COVID-19.
• Summary results:
  The MAH terminated participation in the COVID-PR and associated GA43744 study in May 2024 due to low enrollment associated with diminished in vitro neutralizing potency of casirivimab + imdevimab against Omicron subvariants. Due to a lack of data, no secondary data analyses were performed; hence, there are no results to report. Official cancellation of this study was initiated on 2 August 2024.