Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
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

PAXLOVID

Study drug International non-proprietary name (INN) or common name

NIRMATRELVIR
RITONAVIR

Anatomical Therapeutic Chemical (ATC) code

(J05AE) Protease inhibitors
Protease inhibitors
(J05AE30) nirmatrelvir and ritonavir
nirmatrelvir and ritonavir

Medical condition to be studied

Abortion spontaneous
Abortion induced
Stillbirth
Congenital anomaly
Foetal growth restriction
Small for dates baby
Gestational diabetes
Postpartum haemorrhage
Maternal death

Additional medical condition(s)

Elective termination of pregnancy, congenital malformations
Population studied

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)

Special population of interest

Pregnant women
Study design details

Main study objective

Estimate birth prevalence, prevalence ratio, and prevalence difference of adverse pregnancy, maternal and birth outcomes in pregnant women with COVID-19 exposed to Paxlovid compared with pregnant women with COVID-19 exposed to molnupiravir, other COVID-19 treatments or unexposed to any treatment.

Outcomes

Birth prevalence, prevalence ratio, and prevalence difference of spontaneous abortion, elective termination, stillbirth, preterm delivery (pregnancy outcomes), major congenital malformations, intrauterine growth retardation/small for gestational age (offspring outcomes), gestational diabetes, postpartum haemorrhage, maternal death (maternal outcomes).

Data analysis plan

The study will have a cohort design. Focusing on the target populations, the descriptive component will include tabulations of age, sex, comorbidities, selected concurrent medications, COVID-19 vaccination status, history of COVID-19, current COVID-19 status and setting of Paxlovid use (among Paxlovid users). Comparative analyses will be based on the estimation of risk/prevalence, risk/prevalence ratios, and risk/prevalence differences. Comparative analyses will control for measured confounding within each data source. Aggregated results from each data source will be combined using meta-analytic techniques as numbers allow. If a study population is too small, analyses will be only descriptive, pooling of results from various data sources will be undertaken only if at least 3 independent data points are available.