Pregnancy and Infant Outcomes Following Exposure to PAXLOVID: A Post-Authorization Safety Study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106322
• EU PAS number:
  EUPAS106321
• Study ID:
  106322
• Official title and acronym:
  Pregnancy and Infant Outcomes Following Exposure to PAXLOVID: A Post-Authorization Safety Study
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study aims to answer the research question: What is the risk of pregnancy outcomes of interest, and infant outcomes of interest, among pregnant women with COVID-19 exposed to PAXLOVID, and among pregnant women with COVID-19 unexposed to PAXLOVID? ; To estimate the risk of major congenital malformation [MCM] among pregnant women exposed to PAXLOVID (and not other COVID-19 treatments) during pregnancy (Cohort 1), pregnant women not exposed to PAXLOVID but exposed to other COVID-19 treatments (Cohort 2), and pregnant women with COVID-19 not exposed to any COVID-19 treatments (Cohort 3). The secondary objectives of this study are to: 1. Estimate the risk of pregnancy outcomes (spontaneous abortion, induced termination, stillbirth, livebirth) and the risk of infant outcomes (preterm birth, small for gestational age, postnatal growth deficiency and infant developmental delay) for livebirths among the 3 study cohorts. 2. Pending sufficient sample size, to compare the risk of pregnancy and infant outcomes in Cohort 1 compared to, separately, Cohort 2 and Cohort 3. Exposure (or lack thereof) to COVID-19 treatments will be assessed via the presence of pharmacy and/or medical claims in the Optum Research Database (ORD). This is an observational cohort study using administrative healthcare claims data of commercially insured persons in the United States (the ORD). Medical records will be retrieved for the adjudication of select outcomes from the subset of patients for whom access is available.
• Study status:
  Ongoing

Research institution and networks

Institutions

Pfizer

Networks

OptumInsight Life Sciences, Inc.

Study timelines

Date when funding contract was signed

Planned: 30/01/2023

Actual: 30/01/2023

Study start date

Planned: 01/01/2024

Actual: 02/01/2024

Date of final study report

Planned: 31/07/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C4671038_PROTOCOL_V1_22JUN2023

Updated protocol

C4671038_PROTOCOL AMENDMENT 1_14FEB2024.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable