A Multicenter, Multi-countiy Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults with Severe COVID-19

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39810
• EU PAS number:
  EUPAS34303
• Study ID:
  39810
• Official title and acronym:
  A Multicenter, Multi-countiy Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults with Severe COVID-19
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Hong Kong

  Italy

  Korea, Democratic People's Republic of

  Singapore

  Spain

  United Kingdom

  United States
• Study description:
  GS-US-540-5807: The primary objectives of this study were to assess the clinical course and outcome of adults with severe COVID-19 assessed by: 1) a 7-point ordinal scale on Day 14, and 2) all-cause mortality at Day 28.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Multiple centres: 50 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 24/03/2020

Actual: 23/03/2020

Study start date

Planned: 01/04/2020

Actual: 01/04/2020

Date of final study report

Planned: 01/04/2021

Actual: 15/01/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences

Study protocol

Initial protocol

GS-US-540-5807-appendix-16.1.1-protocol_f-redact

Updated protocol

GS-US-540-5807-appendix-16.1.1-protocol amendment 1_f-redact

Regulatory

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