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Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19 (VTE-COVID)

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ClinicalTrials.gov Identifier: NCT04359212
Recruitment Status : Completed
First Posted : April 24, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
Azienda Ospedaliera di Padova
Information provided by (Responsible Party):
Quovadis Associazione

Brief 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.

Condition or disease Intervention/treatment
COVID-19 Disease Thromboembolism, Venous Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux

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.

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : July 31, 2020


Group/Cohort Intervention/treatment
Medical
subject with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease
Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux
thromboprophylaxis with low-molecular-weight heparin or fondaparinux
Other Name: thromboprophylaxis

Intensive
subject with a confirmed infection for COVID-19 and needing admission to an Intensive Cure Unit for a severe to critical disease
Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux
thromboprophylaxis with low-molecular-weight heparin or fondaparinux
Other Name: thromboprophylaxis




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • aged >= 18 years
  • needing admission to a medical hospital division or to an ICU
  • with a confirmed infection for COVID-19

Exclusion Criteria:

  • aged < 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359212


Locations
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Italy
Giuseppe Camporese
Padova, Italy, 35138
Sponsors and Collaborators
Quovadis Associazione
Azienda Ospedaliera di Padova
Investigators
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Principal Investigator: Paolo Simioni, MD Department of Medicine, University of Padua (I)
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Responsible Party: Quovadis Associazione
ClinicalTrials.gov Identifier: NCT04359212    
Other Study ID Numbers: VTE-COVID
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Quovadis Associazione:
COVID-19 pandemic
Thromboembolism, Venous
Deep Venous Thrombosis
Pulmonary Thrombosis
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin
PENTA
Fondaparinux
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors