Status: Finalised First registered on: 02/04/2021
Last updated on: 18/01/2022
1. Study identification
EU PAS Register NumberEUPAS40414
Official titleNatural history of coagulopathy and use of anti-thrombotic agents in COVID-19 patients and persons vaccinated against SARS-COV-2
Study title acronym
Study typeObservational study
Brief description of the studyAim/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
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)n/a
Other study registration identification numbers and URLs as applicablen/a
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsHealth Data Science
Department/Research groupDepartment of Medical Informatics - Health Data Science
Organisation/affiliationErasmusMC
Website/Homepagehttps://www.healthdatascience.nl/contact
Details of (Primary) lead investigator
Title Professor
Last name Prieto-Alhambra
First name Daniel
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

Pharmacoepidemiology Research Group
IQVIA
Countries in which this study is being conducted
International study

France
Germany
Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed12/11/202012/11/2020
Start date of data collection01/01/201701/01/2017
Start date of data analysis01/03/202101/03/2021
Date of interim report, if expected
Date of final study report30/09/202115/10/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherEuropean Medicines Agency tender100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Daniel
First name Prieto-Alhambra
Address line 1Botnar Research Centre, Windmill Road
Address line 2 
Address line 3 
CityOxford 
PostcodeOX37LD 
CountryUnited Kingdom
Phone number (incl. country code)31107044129 
Alternative phone number 
Fax number (incl. country code) 
Email address d.prietoalhambra@erasmusmc.nl
Public Enquiries
Title Professor 
Last name Prieto-Alhambra 
First name Daniel 
Address line 1Dr. Molewaterplein 40 
Address line 2 
Address line 3 
CityRotterdam 
Postcode3015 GD 
CountryNetherlands 
Phone number (incl. country code)31107044129 
Alternative phone number 
Fax number (incl. country code) 
Email address d.prietoalhambra@erasmusmc.nl 
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