COVID-19TVP-COVID-RIVNCT04361981
Influence of COVID-19 Infection in Thromboembolic Venous Disease: National Cohort Study
An observational study of COVID-19, run by Sociedad Espanola de Angiologia y Cirugia Vascular at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- Deep Venous Disease Diagnostic
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2020to 31 Dec 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with COVID-19 infection who suffer from deep venous disease
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Spain1 site
Red de Investigacion Vascular (SEACV)
Madrid, 28004
Joaquin De Haro, MD, +34 626022977, deharojoaquin@yahoo.es
About this study
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.
Read more
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.
- Conditions
- COVID-19
- Being tested
- Deep Venous Disease Diagnostic
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Venous Disease DiagnosticOther
Clinical and/or echographic diagnosis of Deep Venous Disease in a patient with COVID-19 infection
| Study group | Role | What they receive |
|---|---|---|
| Cases | COVID-19 infection patients with a Deep Venous Disease event Receives: Other: Deep Venous Disease Diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep Venous Disease Incidence
Incidence of Deep Venous Disease events in patients with COVID-19 infection
Measured: 30 days
Secondary outcomes (3)
30-days mortality
30-days mortality in COVID-19 infection patients with a Deep Venous Disease event
Measured: 30 days
ICU admission
Rate of ICU admission in COVID-19 infection patients with a Deep Venous Disease event
Measured: 30 days
Anticoagulant treatment
Type of anticoagulant treatment in COVID-19 infection patients with a Deep Venous Disease event
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study startApr 2020 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sociedad Espanola de Angiologia y Cirugia Vascular
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Joaquin De Haro, MD, Study chair, Hospital Universitario Getafe. Red de Investigacion Vascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361981
- Sponsor's protocol ID
- RIV-R3
- Acronym
- TVP-COVID-RIV
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Cohort Study to Assess the Influence of COVID-19 Infection in Thromboembolic Venous Disease:
- ClinicalTrials.gov ID
- NCT04361981
- Acronym / sponsor ID
- TVP-COVID-RIV / RIV-R3
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sociedad Espanola de Angiologia y Cirugia VascularResearch network
- Study start
- Apr 2020 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Deep Venous Disease DiagnosticCOVID-19 infection patients with a Deep Venous Disease event |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with COVID-19 infection who suffer from deep venous disease
Key inclusion criteria (5 listed)
- 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.
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Venous Disease DiagnosticClinical and/or echographic diagnosis of Deep Venous Disease in a patient with COVID-19 infection | Other | Cases |
Primary outcome
Deep Venous Disease Incidence
Time frame: 30 days
Incidence of Deep Venous Disease events in patients with COVID-19 infection
3 secondary outcomes
30-days mortality
Time frame: 30 days
ICU admission
Time frame: 30 days
Anticoagulant treatment
Time frame: 30days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joaquin De Haro, MD study chair
Hospital Universitario Getafe. Red de Investigacion Vascular
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Sociedad Espanola de Angiologia y Cirugia Vascular at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joaquin De Haro, MD (+34 626022977, deharojoaquin@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep Venous Disease Incidence (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.