COVID-19 International Drug Pregnancy Registry (COVID-PR)

Study type

• Study topic:
  Other
• Study topic, other:
  COVID-19 International Drug Pregnancy Registry
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  VEKLURY

  XEVUDY
• Name of medicine, other:
  REGEN-COV, Lagevrio
• Study drug International non-proprietary name (INN) or common name:
  REMDESIVIR

  SOTROVIMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (J06BD05) sotrovimab

  sotrovimab
• Medical condition to be studied:
  SARS-CoV-2 test positive

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The objective of the COVID-19 International Drug Pregnancy Registry (COVID-PR) is to evaluate obstetric, neonatal, and infant outcomes among women treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from the first day of the LMP to end of pregnancy. ; For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of LMP.
• Outcomes:
  Risk of obstetric outcomes (spontaneous abortion, intrauterine growth restriction, gestational diabetes, gestational hypertension, postpartum hemorrhage, Caesarean delivery), neonatal outcomes (major congenital malformations, low birth weight, small for gestational age, neonatal infections, stillbirth, neonatal death, preterm birth), and infant outcomes until 12 months of age.
• Data analysis plan:
  The reference groups will provide an estimate of the expected incidence of obstetric, neonatal, and infant outcomes in women from a similar source population and risk factors as the exposed cohort. ; The exposed and reference cohorts will be matched by calendar time, country of residence, gestational week at the time of COVID-19 infection (± 2 weeks), and severity of COVID-19.