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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/50701
• EU PAS number:
  EUPAS50700
• Study ID:
  50701
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

TriNetX

Belgium

Study timelines

Date when funding contract was signed

Actual: 27/04/2022

Study start date

Planned: 15/02/2023

Actual: 15/02/2023

Date of final study report

Planned: 31/07/2023

Actual: 21/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

LY3853113 J2X-MC-B003 RWE Protocol_Redacted

Updated protocol

LY3853113 J2X-MC-B003(a) RWE Protocol_Redacted

Regulatory

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