Study identification

PURI

https://redirect.ema.europa.eu/resource/46384

EU PAS number

EUPAS34411

Study ID

46384

Official title and acronym

Real-world characteristics, management and outcomes of subjects screened or diagnosed with COVID-19 in Spain (COVID-19 REAL)

DARWIN EU® study

No

Study countries

Spain

Study description

The study is a non-interventional, retrospective, database, cohort study based on anonymized and routinely-collected health care data from several Spanish Hospitals which have been mapped to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). The present study aims to participate in the OHDSI international collaboration by analyzing data from Spain. Further analyses to answer specific, local COVID-19 research questions that may arise during the ongoing crisis might be also considered.

Study status

Finalised
Research institution and networks

Institutions

TFS HealthScience (TFS)
Sweden
First published:
03/04/2024
Institution
Non-Pharmaceutical companyENCePP partner
Hospital Vall Hebron Barcelona (Spain), Hospital del Mar Barcelona (Spain), Hospital de Cruces Barakaldo (Spain), Hospital San Eloy Barakaldo (Spain), Hospital Urduliz Urduliz (Spain)

Contact details

Neus Valveny

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

TFS, IOMED, Bill Gates Foundation (through Oxford University)
Study protocol
Initial protocol

OHDSI COVID-19 Real_protocol_25Mar20

English (649.19 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable