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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BX) Other viral vaccines
• Medical condition to be studied:
  SARS-CoV-2 test positive

  COVID-19 immunisation

Population studied

• Short description of the study population:
  People with a specific clinical diagnosis of COVID-19 or a positive PCR test against SARS-CoV-2 were included. People with <1 year of data visibility before index date were excluded.; ; The following study cohorts will be defined: 1) General population, 2) Persons 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.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  COVID-19 patients
• Estimated number of subjects:
  6000000

Study design details

• Main study objective:
  1-To estimate background rates of thrombo-embolic events (TEE) 2-To estimate rates of TEE in persons vaccinated against SARS-CoV-2 3-To estimate the incidence of TEE among COVID-19 patients 4-To study the risks of worsening of COVID-19 stratified by the occurrence of TEE 5-To study the risk factors for TEE in COVID-19 patients 6-To derive and externally validate prediction tools for TEE
• Outcomes:
  1.Venous thromboembolic events 2.Arterial thromboembolism 3.Rare thrombotic and coagulopathy events: disseminated intravascular coagulation, immune thrombocytopenia, thrombotic thrombocytopenia purpura, cerebral venous sinus thrombosis, and intracranial venous thrombosis 4.Other cardiovascular events 5.All-cause mortality
• Data analysis plan:
  Background rates will be estimated per 100,000 person-years, with individuals identified as of the 1st January in 2017, 2018, 2019, and 2020. We will estimate the incidence for all outcomes at 7, 14, 21, and 28 days following vaccination against SARS-CoV-2, and 30, 60, and 90 days for COVID-19 patients. Age-sex adjusted incidence rate ratios for post-vaccine/background rates for all events will be estimated, stratified by age, sex, and data source. We will use a multistate model to summarise risks of worsening among COVID-19 patients stratified by those with and without thromboembolic events of interest. The impact of risk factors on risks of venous and arterial thromboembolic events among COVID-19 patients will be assessed using two approaches: 1) Cox models to estimate relative risks for pre-specified risk factors, 2) data-driven using Lasso regression and external validatio

Documents

Study results

EMAROC13_Final report

EMAROC13_report3_enceppupload

Study report

Progress_report_2_vaccinesTTS_enceppupload

Progress_report_BackgroundRates_enceppupload

Study, other information

Progress_report_BackgroundRates_enceppupload.pdf

Study publications

Burn E, Li X, Kostka K, Stewart HM, Reich C, Seager S, Duarte‐Salles T, Fernand…