Influence of COVID-19 Infection in Thromboembolic Venous Disease: National Cohort Study (TVP-COVID-RIV)

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Other: Deep Venous Disease Diagnostic

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28004
    • Red de Investigacion Vascular (SEACV)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with COVID-19 infection who suffer from deep venous disease

Description

Inclusion Criteria:

• Adults (age 18 years) considered as a case of COVID-19 disease with suspected DVT in lower and/or upper limbs: (i) A laboratory test confirming COVID-19 infection or (ii) a clinical diagnosis of COVID-19 infection (without any testing) is considered.

  - Suspected DVT:

• Patients with clinical data of suspected DVT
• and/or patients with analytical data on suspected DVT
• and/or patients with ultrasound data of suspected DVT

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; COVID-19 infection patients with a Deep Venous Disease event	Other: Deep Venous Disease Diagnostic; Clinical and/or echographic diagnosis of Deep Venous Disease in a patient with COVID-19 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deep Venous Disease Incidence	Incidence of Deep Venous Disease events in patients with COVID-19 infection	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-days mortality	30-days mortality in COVID-19 infection patients with a Deep Venous Disease event	30 days
ICU admission	Rate of ICU admission in COVID-19 infection patients with a Deep Venous Disease event	30 days
Anticoagulant treatment	Type of anticoagulant treatment in COVID-19 infection patients with a Deep Venous Disease event	30days

Collaborators and Investigators

• Sponsor: Sociedad Espanola de Angiologia y Cirugia Vascular
• Investigators: Study Chair: Joaquin De Haro, MD, Hospital Universitario Getafe. Red de Investigacion Vascular

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RIV-R3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No