COVID-19 Clinical Trial
Official title:
National Cohort Study to Assess the Influence of COVID-19 Infection in Thromboembolic Venous Disease:
There is an urgent need to understand the outcomes of COVID-19 infected patients regarding
the thromboembolic venous disease. Capturing real-world data and sharing Spanish national
experience will inform the management of this complex group of patients, improving their
clinical care.
Interventions are needed to reduce both the incidence and severity of COVID-19. Although it
shares characteristics with other similar viruses that also arose in outbreaks, the
physiological mechanisms of the virus and its responses on the host are not yet fully known.
There are indications that the clinical picture of this disease is in a procoagulant state,
with possible increase in episodes of thromboembolic disease. This study aims to analyze the
influence of COVID-19 on the incidence of deep vein thrombosis (DVT) in lower and upper
limbs, and the variation in the clinical presentation of COVID-19, as well as to provide new
evidence applicable to the clinical management of these patients and the establishment of
prognostic factors that help early take therapeutic decisions.
To this end, an observational, multicenter, national cohorts study will be carried out,
sponsored by the Spanish Society of Angiology and Vascular Surgery (SEACV) and the Spanish
Chapter of Phlebology and Linfology through its Vascular Research Network (RIV), which will
collect demographic variables, comorability, concomitant treatment, analytical status and
complementary and ultrasound diagnostic tests, parameters of clinical evolution, therapeutic
and complications and mortality to 30 days. All national centers you wish to participate
through a secure server that will be accessed through the SEACV and CEFyL website.
The global community has recognised that rapid dissemination and completion of studies in
COVID-19 infected patients is a high priority, so we encourage all stakeholders (local
investigators, ethics committees, IRBs) to work as quickly as possible to approve this
project.
This investigator-led, non-commercial, non-interventional study is extremely low risk, or
even zero risk. This study does not collect any patient identifiable information (including
no dates) and data will not be analysed at hospital-level.
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