COVID-19 DiseaseVTE-COVIDNCT04359212
Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19
An observational study of COVID-19 Disease and Thromboembolism, Venous, run by Quovadis Associazione at 1 site in Italy.
Trial summary
The aim of this study is to verify if patients admitted to hospital in a medical division and in the intensive care unit for a COVID-19 infection are at higher risk of developing a VTE complication and if they actually present an increased hypercoagulable state. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Disease, Thromboembolism, Venous
- What is being tested?
- thromboprophylaxis with low-molecular-weight heparin or fondaparinux
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2020to 31 Jul 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients aged > 18 years with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease (Group 1) or to the ICU for a severe to critical disease (Group 2) will be eligible for the study.
Who may be able to join
- aged >= 18 years
- needing admission to a medical hospital division or to an ICU
- with a confirmed infection for COVID-19
Who cannot join
- aged < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increased Risk of Venous Thromboembolism and Higher Hypercoagulable State in Patients Recovered in Intensive Care Unit and in Medical Ward for Coronavirus Disease 2019 (COVID-19)
The aim of this study is to verify if patients admitted to hospital in a medical division and in the intensive care unit for a COVID-19 infection are at higher risk of developing a VTE complication and if they actually present an increased hypercoagulable state.
Read the detailed description
Between December 2019 and January 2020, a new type of coronavirus, named as "coronavirus disease 2019 - COVID-19" by the World Health Organization, has widely spread throughout the world, becoming a global health threat. The new COVID-19 is similar to other two types of coronavirus that in the past two decades have emerged as cause of severe human disease: Severe Acute Respiratory Syndrome CoV (SARS-CoV) and Middle East Respiratory Syndrome CoV (MERS-CoV). Severe respiratory disease or respiratory failure are the principal symptoms of critical patients, needing a management in ICU with mechanical ventilation.18 Data coming from laboratory results show a leucopenia mainly represented by a lymphopenia, that is a cardinal feature of COVID-19. Moreover, the concentration of several serum pro-thrombotic cytokines, such as interleukins (mainly IL-6, increased in 52% of patients), TNF-α, D-Dimer are reported to be significantly higher in COVID-19 patients, and significantly higher in ICU-patients than in non-ICU patients, suggesting an increased hypercoagulable state that, joined to the other main risk factors (immobilization, ICU admission, mechanical ventilation, infective disease), place these patients to a potential greater risk of developing VTE complications.
- Conditions
- COVID-19 Disease, Thromboembolism, Venous
- Being tested
- thromboprophylaxis with low-molecular-weight heparin or fondaparinux
- Keywords
- COVID-19 pandemic, Thromboembolism, Venous, Deep Venous Thrombosis, Pulmonary Thrombosis
- Medical subject headings
- Venous Thromboembolism, COVID-19, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thromboprophylaxis with low-molecular-weight heparin or fondaparinuxDrug
Also called thromboprophylaxis
thromboprophylaxis with low-molecular-weight heparin or fondaparinux
| Study group | Role | What they receive |
|---|---|---|
| Medical | subject with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease Receives: Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux | |
| Intensive | subject with a confirmed infection for COVID-19 and needing admission to an Intensive Cure Unit for a severe to critical disease Receives: Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism
Measured: 28 days
Secondary outcomes (1)
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism
Measured: 28 days
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 start1 May 2020
- Primary completion30 Jun 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 DiseaseStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quovadis Associazione
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera di Padova
- Responsible party
- Sponsor
- Investigators
- Paolo Simioni, MD, Principal investigator, Department of Medicine, University of Padua (I)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359212
- Sponsor's protocol ID
- VTE-COVID
- Acronym
- VTE-COVID
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
PubMed 35244208Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.
PubMed 33502773
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Risk of Venous Thromboembolism and Higher Hypercoagulable State in Patients Recovered in Intensive Care Unit and in Medical Ward for Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04359212
- Acronym / sponsor ID
- VTE-COVID / VTE-COVID
- Conditions
- COVID-19 Disease, Thromboembolism, Venous
- Keywords
- COVID-19 pandemic, Thromboembolism, Venous, Deep Venous Thrombosis, Pulmonary Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Quovadis AssociazioneUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera di Padova
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- 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.
The aim of this study is to verify if patients admitted to hospital in a medical division and in the intensive care unit for a COVID-19 infection are at higher risk of developing a VTE complication and if they actually present an increased hypercoagulable state.
Detailed description
Between December 2019 and January 2020, a new type of coronavirus, named as "coronavirus disease 2019 - COVID-19" by the World Health Organization, has widely spread throughout the world, becoming a global health threat. The new COVID-19 is similar to other two types of coronavirus that in the past two decades have emerged as cause of severe human disease: Severe Acute Respiratory Syndrome CoV (SARS-CoV) and Middle East Respiratory Syndrome CoV (MERS-CoV). Severe respiratory disease or respiratory failure are the principal symptoms of critical patients, needing a management in ICU with mechanical ventilation.18 Data coming from laboratory results show a leucopenia mainly represented by a lymphopenia, that is a cardinal feature of COVID-19. Moreover, the concentration of several serum pro-thrombotic cytokines, such as interleukins (mainly IL-6, increased in 52% of patients), TNF-α, D-Dimer are reported to be significantly higher in COVID-19 patients, and significantly higher in ICU-patients than in non-ICU patients, suggesting an increased hypercoagulable state that, joined to the other main risk factors (immobilization, ICU admission, mechanical ventilation, infective disease), place these patients to a potential greater risk of developing VTE complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical | – | Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinuxsubject with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease |
| Intensive | – | Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinuxsubject with a confirmed infection for COVID-19 and needing admission to an Intensive Cure Unit for a severe to critical disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients aged > 18 years with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease (Group 1) or to the ICU for a severe to critical disease (Group 2) will be eligible for the study.
Key inclusion criteria (3 listed)
- aged >= 18 years
- needing admission to a medical hospital division or to an ICU
- with a confirmed infection for COVID-19
Key exclusion criteria (1 listed)
- aged < 18 years
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 |
|---|---|---|
| thromboprophylaxis with low-molecular-weight heparin or fondaparinuxAlso: thromboprophylaxisthromboprophylaxis with low-molecular-weight heparin or fondaparinux | Drug | Intensive, Medical |
Primary outcome
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism
Time frame: 28 days
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism
1 secondary outcome
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Derived from this study: PubMed 35244208Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
- Derived from this study: PubMed 33502773Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.
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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.
Paolo Simioni, MD principal investigator
Department of Medicine, University of Padua (I)
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 Disease and Thromboembolism, Venous, run by Quovadis Associazione at 1 site in Italy.
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 3 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: finished, as of the sponsor's last update on 17 Sep 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359212, which also lists 2 linked publications.
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 17 Sep 2020.