A Multi-center, Longitudinal, Clinical Real-World Study to Evaluate Mortality and Clinical Outcomes in Hospitalized Adults with COVID-19 Infection in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42040
• EU PAS number:
  EUPAS35465
• Study ID:
  42040
• Official title and acronym:
  A Multi-center, Longitudinal, Clinical Real-World Study to Evaluate Mortality and Clinical Outcomes in Hospitalized Adults with COVID-19 Infection in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  GS-US-540-5835: The primary objectives of this study were to estimate the mortality rate in hospitalized adults aged ≥ 18 years with coronavirus disease 2019 (COVID-19) in the United States (US) using real-world data (RWD) and to compare the mortality rate of hospitalized patients from the RWD clinical setting to patients participating in remdesivir (RDV, GS-5734™, Veklury®) studies including compassionate use.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Multiple centres: 13 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 24/03/2020

Study start date

Actual: 20/01/2020

Data analysis start date

Actual: 30/03/2020

Date of interim report, if expected

Actual: 01/04/2020

Date of final study report

Planned: 30/09/2020

Actual: 10/04/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences

Study protocol

Initial protocol

GS-US-540-5835-appendix-16.1.1-protocol_f-redact

Regulatory

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