A standing cohort to understand the characteristics of patients with COVID-19 and contextualize the COVID-19 complication and safety events of interests using US OPTUM EHR data

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48655
• EU PAS number:
  EUPAS48654
• Study ID:
  48655
• Official title and acronym:
  A standing cohort to understand the characteristics of patients with COVID-19 and contextualize the COVID-19 complication and safety events of interests using US OPTUM EHR data
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The main purpose of the study is to understand the characteristics and healthcare utilization of patients with COVID 19 and to examine the COVID 19 complication and safety events of interests.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 07/09/2022

Actual: 07/09/2022

Study start date

Planned: 01/05/2022

Actual: 01/05/2022

Date of final study report

Planned: 30/12/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C4671040 NIS Protocol V1_Final 29Apr2022_Redacted

Updated protocol

C4671040 Non Interventional Study Protocol Amendment 2_Version 3.0_(clean)_23Aug2022_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable