Study identification

PURI

https://redirect.ema.europa.eu/resource/45221

EU PAS number

EUPAS40414

Study ID

45221

Official title and acronym

Natural history of coagulopathy and use of anti-thrombotic agents in COVID-19 patients and persons vaccinated against SARS-CoV-2

DARWIN EU® study

No

Study countries

France
Germany
Italy
Netherlands
Spain
United Kingdom

Study description

Aim/s To estimate incidence rates of coagulopathy and thromboembolic events in the general population, in COVID-19 patients, and in recipients of COVID-19 vaccine/s Design We will perform a network cohort study using data mapped to the Observational Medical Outcomes Partnership (OMOP) Common Data Model Population Cohorts: 1) General population, 2) Vaccinated against SARS-CoV-2 with a first dose, 3) Persons vaccinated against SARS-CoV-2 with a second dose, 4) Persons tested positive for SARS-CoV-2, 5) Persons tested positive for SARS-CoV-2 or with a clinical diagnosis of COVID-19, 6) Persons hospitalised with COVID-19, and 7) Persons requiring intensive services during a hospitalisation with COVID-19 Outcomes Venous thromboembolic events, arterial thromboembolic events, rare thrombotic and coagulopathy events, cardiovascular events, and mortality will be identified for all study populations. The occurrence of these events of interest will be identified at 7, 14, 21, and 28 days following vaccination against SARS-CoV-2, while the occurrence of venous thromboembolic and arterial thromboembolic events will be identified in the 30-, 60- and 90-days post-index date for COVID-19 patients. COVID-19 worsening will be defined as increasing care intensity (e.g. from outpatient to inpatient, from inpatient to receiving intensive care services) and/or mortality Data sources Primary care and hospital records from NL (IPCI), IT (IQVIA LPD Italy), FR (IQVIA LPD France), DE (IQVIA DA Germany), ES (SIDIAP and HM), and the UK (CPRD GOLD, CPRD AURUM, and linked HES) Analyses Background rates will be estimated per 100,000 person-years for 2017-2019, at 7, 14, 21, and 28 days following vaccination against SARS-CoV-2, and 30, 60, and 90 days for COVID-19 patients. Rates will be stratified by socio-demographics and cohort. Post-vaccine/background rate ratios will be estimated adjusted for age and sex. Multi-state models will be fitted to study COVID-19 worsening

Study status

Finalised
Research institution and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution
Non-Pharmaceutical companyENCePP partner

Contact details

Daniel Prieto-Alhambra

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 final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol
English (1.62 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable