A Multicenter, Retrospective, Observational Study Using Real-world Data to Describe the Safety, Treatment Pattern and Effectiveness of Nirmatrelvir/Ritonavir among Patients treated with Nirmatrelvir/Ritonavir in China

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/103410
• EU PAS number:
  EUPAS103409
• Study ID:
  103410
• Official title and acronym:
  A Multicenter, Retrospective, Observational Study Using Real-world Data to Describe the Safety, Treatment Pattern and Effectiveness of Nirmatrelvir/Ritonavir among Patients treated with Nirmatrelvir/Ritonavir in China
• DARWIN EU® study:
  No
• Study countries:
  China
• Study status:
  Finalised

Research institutions and networks

Institutions

Guangzhou Medical University

Multiple centres: 9 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 08/09/2022

Study start date

Planned: 06/03/2023

Actual: 05/12/2022

Data analysis start date

Actual: 26/02/2024

Date of interim report, if expected

Actual: 25/07/2023

Date of final study report

Planned: 17/04/2024

Actual: 07/06/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C4671043_Protocol-5Dec2022-Redacted

Updated protocol

C4671043_Protocol-5Dec2022-full protocol.pdf

Regulatory

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